Acetaminophen

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Acetaminophen Recall

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Side Effects & Adverse Reactions

Liver warning: this product contains acetaminophen. The maximum daily dose of this product is 6 tablets (3,000 mg) in 24 hours. Severe liver damage may occur if you take

more than 4,000 mg of acetaminophen in 24 hours
with other drugs containing acetaminophen
3 or more alcoholic drinks every day while using this product

with any other drug containing acetaminophen (prescription or nonprescription). If you are not sure whether a drug contains acetaminophen, ask a doctor or pharmacist.
if you are allergic to acetaminophen or any of the inactive ingredients in this product.

liver disease.

Pain gets worse or lasts more than 10 days.
Fever gets worse or lasts more than 3 days.
New symptoms occur.
Redness or swelling is present.

These could be signs of a serious condition.

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Legal Issues

There is currently no legal information available for this drug.

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FDA Safety Alerts

There are currently no FDA safety alerts available for this drug.

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Manufacturer Warnings

There is currently no manufacturer warning information available for this drug.

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FDA Labeling Changes

There are currently no FDA labeling changes available for this drug.

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Uses

Temporary relieves minor aches and pains due to:

The common cold • Headache
Backache • Minor pain of arthritis
Toothache • Muscular aches
Premenstrual and menstrual cramps

* Temporarily reduces fever

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History

There is currently no drug history available for this drug.

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Other Information

There are no additional details available for this product.

Sources

Acetaminophen Manufacturers

Marlex Pharmaceuticals Inc

Acetaminophen | Marlex Pharmaceuticals Inc

Do not take more than directed (see overdose warning)

Adults and Children 12 years and over:
Take 2 tablets every 6 hours while symptoms last.
Do not take more than 6 tablets in 24 hours, unless directed by a doctor.
Do not use for more than 10 days unless directed by a doctor.
Children under 12 years:
ask a doctor.

No Recall
H-e-b

Acetaminophen | H-e-b

• do not take more than directed (see overdose warning)
adults

▪ take 2 caplets every 8 hours with water.
▪ swallow whole; do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor

under 18 years of age

▪ ask a doctor

No Recall
Meijer

Acetaminophen | Veloxis Pharmaceuticals, Inc

2.1 Administration Instructions Take ENVARSUS XR on an empty stomach at the same time of the day, preferably in the morning (to ensure consistent and maximum possible drug exposure) [see Clinical Pharmacology (12.2)]. Swallow ENVARSUS XR whole with fluid (preferably water); do not chew, divide, or crush the tablets. If a dose is missed, take it as soon as possible within 15 hours after missing the dose; beyond the 15-hour time frame, wait until the usual scheduled time to take the next regular daily dose. Do not double the next dose. Avoid eating grapefruit or drinking grapefruit juice or alcoholic beverage while taking ENVARSUS XR [see Drug Interactions (7.2)]. African-American patients, compared to Caucasian patients, may need to be titrated to higher ENVARSUS XR dosages to attain comparable trough concentrations [see Use in Specific Populations (8.8) and Clinical Pharmacology (12.2)]. 2.2 Conversion from Tacrolimus Immediate-Release Formulations
To convert from a tacrolimus immediate-release product to ENVARSUS XR, administer an ENVARSUS XR once daily dose that is 80% of the total daily dose of the tacrolimus immediate-release product. Monitor tacrolimus whole blood trough concentrations and titrate ENVARSUS XR dosage to achieve target whole blood trough concentration ranges of 4 to 11 ng/mL.
2.3 Therapeutic Drug Monitoring
Measure tacrolimus whole blood trough concentrations at least two times on separate days during the first week after initiation of dosing and after any change in dosage, after a change in co-administration of CYP3A inducers and/or inhibitors, or after a change in renal or hepatic function. When interpreting measured concentrations, consider that the time to achieve tacrolimus steady state is approximately 7 days after initiating or changing the ENVARSUS XR dose.

Monitor tacrolimus whole blood trough concentrations using a validated assay [e.g., immunoassays or high-performance liquid chromatography with tandem mass spectrometric detection (HPLC/MS/MS)]. The immunosuppressive activity of tacrolimus is mainly due to the parent drug rather than to its metabolites. Immunoassays may react with metabolites as well as the parent drug. Therefore, whole blood tacrolimus trough concentrations obtained with immunoassays may be numerically higher than concentrations obtained with an assay using HPLC/MS/MS. Comparison of the whole blood tacrolimus trough concentrations of patients to those described in the prescribing information and other published literature must be made with knowledge of the assay method(s) employed.

No Recall
Mikart, Inc.

Acetaminophen | Mikart, Inc.

The usual adult dosage is one (1) Acetaminophen, Caffeine and Dihydrocodeine Bitartrate Tablet orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than one tablet should be taken in a four hour period. No more than five (5) doses, or five (5) tablets should be taken in a 24-hour period.

No Recall
Spirit Pharmaceuticals, Llc

Acetaminophen | Spirit Pharmaceuticals, Llc

take only as recommended - see Overdose warning do not exceed 4 doses per 24 hours adults and children 12 years and over 2 LiquiCaps with water every 6 hours children under 12 years ask a doctor when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

No Recall
A&z Pharmaceutical, Inc.

Acetaminophen |

No Recall
Himprit Pharmachem Pvt Ltd

Acetaminophen | Himprit Pharmachem Pvt Ltd

* do not use more that directed (see overdose warning) * adults and children 12 years and over : take 2 caplets every 6 hours as needed * do not take more than 8 caplets in 24 hours * Children under 12 years : do not use this adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) and could cause serious health problems.

No Recall
Spirit Pharmaceuticals, Llc

Acetaminophen | Spirit Pharmaceuticals, Llc

take only as recommended - see Overdose warning do not exceed 6 doses per 24 hours adults and children 12 years and over 2 LiquiCaps with water every 4 hours children under 12 years ask a doctor when using other DayQuil or NyQuil products, carefully read each label to insure correct dosing

No Recall
Tds Pharm Co., Ltd

Acetaminophen | Tds Pharm Co., Ltd

do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets every 4 to 6 house as needed do not take more than 8 tablets in 24 hours do not use for more than 10 days unless directed by a doctor

children under 12 years
do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
New World Imports, Inc

Acetaminophen | New World Imports, Inc

Adults and children 12 years of age and older: Take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children 6-11 years of age: Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.

Children under 6 years of age: Do not sue this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

No Recall
Contract Pharmacy Services-pa

Acetaminophen | Contract Pharmacy Services-pa

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Physicians Total Care, Inc.

Acetaminophen | Physicians Total Care, Inc.

Do not take more than directed
Age Dose Adults and Children 12
years and over Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6-11 years Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours Children under 6 years Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Stat Rx Usa Llc

Acetaminophen | Stat Rx Usa Llc

Oral: One or two tablets every four hours. Total daily dosage should not exceed 6 tablets.

Extended and repeated use of this product is not recommended because of the potential for physical dependence.

No Recall
Rebel Distributors Corp

Acetaminophen | Rebel Distributors Corp

Do not take more than directed

° adults and children 12 years and older, take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours. ° children under 12, consult a doctor before use.

No Recall
Remedyrepack Inc.

Acetaminophen | Remedyrepack Inc.

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Keltman Pharmaceuticals Inc.

Acetaminophen | Keltman Pharmaceuticals Inc.

Do not take more than directed
Age Dose Adults and Children 12
years and over Take 1-2 tablets every 4-6 hours, as needed. Do not take more than 8 tablets in 24 hours. Children under 12 years Do not use.

No Recall
Cispharma, Inc

Acetaminophen | Cispharma, Inc

adults and children 12 years and over
take 2 tablets every 4 to 6 hours while symptoms last if needed, tablets may be crushed and should be taken immediately. Take the entire dose for best results. Crushing the tablets will result in bitter taste. do not take more than 8 tablets in 24 hours do not use more than 10 days unless directed by a doctor
children under 12 years
do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Cispharma, Inc

Acetaminophen | Cispharma, Inc

adults and children 12 years and over
take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours do not use more than 10 days unless directed by a doctor
children 6 years to 11 years
take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours
children under 6 years
do not use adult Regular Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Cispharma, Inc

Acetaminophen | Cispharma, Inc

adults and children 12 years and over
take 2 caplets every 6 hours as needed. do not take more than 8 caplets in 24 hours do not use more than 10 days unless directed by a doctor
children under 12 years
do not use this adult product in children under 12 years of age: this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Cardinal Health

Acetaminophen | Cardinal Health

do not take more than directed (see overdose warning)
adults and children 12 years and over: take 2 tablets every 4 to 6 hours as needed. Do not take more than 8 tablets in 24 hours. Do not take for more than 10 days unless directed by doctor. children under 12 years: Do not use this adult extra strength product in children under 12 years of age. This will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Cardinal Health

Acetaminophen | Cardinal Health

Do not take more than directed (see overdose warning)

Adults and children 12 years of age and over
take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours do not use more than 10 days unless directed by a doctor
Children 6-11 years
take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor
Children under 6 years
do not use this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Cardinal Health

Acetaminophen | Cardinal Health

do not take more than directed (see overdose warning) Adults and children 12 years of age and over take 2 caplets every 4 to 6 hours while symptoms last do not take more than 8 caplets in 24 hours do not use for more than 10 days unless directed by a doctor Children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

No Recall
Time Cap Labs Inc

Acetaminophen | Time Cap Labs Inc

Directions: Do not take more than directed (see overdose warning)

adults and children 12 years and over: take 2 caplets every 4 to 6 hours while symptoms last

do not take more than 8 caplets in 24 hours

do not take for more than 10 days unless directed by a doctor

children under 12 years: do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended does (overdose) of acetaminophen any may cause lier damage.

No Recall
Accudial Pharmaceutical, Inc.

Acetaminophen | Accudial Pharmaceutical, Inc.

This product does not contain directions or complete warnings for adult use.
shake well before using if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours when weight is known: use the rotating bottle label to find the child's weight and read the correct dose. This is the most accurate dose.
when weight is unknown: use the age chart on the rotating label. use only enclosed dosing syringe and adapter to dose this product. Do not use any other dosing device Age (yr) Dose (mL or tsp) under 6 mos. ask a doctor 6 mos. to under 2 2.5 mL or ½ tsp. 2 to under 4 5 mL or 1 tsp. 4 to under 6 7.5 mL or 1½ tsp. 6 to under 9 10 mL or 2 tsp. 9 to under 11 12.5 mL or 2½ tsp. 11 to under 12 15 mL or 3 tsp. or as directed by a doctor tsp. = teaspoon mL = milliliter

No Recall
Time Cap Labs Inc

Acetaminophen | Time Cap Labs Inc

Directions
do not take more than directed (see overdose warning) adults and children 12 years and over
take 2 tablets (1,000 mg) every 6 hours while symptoms last do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years
do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

No Recall
H.j. Harkins Company, Inc.

Acetaminophen | H.j. Harkins Company, Inc.

do not take more than directed (see overdose warning).
if needed, repeat dose every 4 hours or as directed by a doctor
do not give more than 5 doses in 24 hours
children under 2 yrs (under 24 lbs)
ask a doctor
children 2-3 years (24-35 lbs)
1 teaspoonful (5 mL)
children 4-5 years (36-47 lbs)
1 1/2 teaspoonfuls (7.5 mL)
children 6-8 years (48-59 lbs)
2 teaspoonfuls (10 mL)
children 9-10 years (60-71 lbs)
2 1/2 teaspoonfuls (12.5 mL)
children 11 years (72-95 lbs)
3 teaspoonfuls (15 mL)
adults & children 12 years & older
4 teaspoonfuls (20 mL)
Other information
Store at room temperature 20°-25°C (68°-77°F)

No Recall
Time Cap Labs Inc

Acetaminophen | Time Cap Labs Inc

Directions
do not take more than directed (see overdose warning) adults and children 12 years and over
take 2 tablets (1,000 mg) every 6 hours while symptoms last do not take more than 6 tablets (3,000 ng) in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor children under 12 years
do not use this adult extra strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage

No Recall
Cardinal Health

Acetaminophen | Cardinal Health

Do not take more than directed.
adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours. children 6 to 11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours. children under 6 years Do not use adult regular strength products in children under 6 years of age: this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Physicians Total Care, Inc.

Acetaminophen | Physicians Total Care, Inc.

find right dose on chart if possible, use weight to dose; otherwise, use age if needed, repeat dose every 4 hours do not use more than 5 times in 24 hours Weight Age Dose under 24 lbs under 2 years ask a doctor 24 to 35 lbs 2 to 3 years 1 teaspoon (5 mL) 36 to 47 lbs 4 to 5 years 1 ½ teaspoons (7.5 mL) 48 to 59 lbs 6 to 8 years 2 teaspoons (10 mL) 60 to 71 lbs 9 to 10 years 2 ½ teaspoons (12.5 mL) 72 to 95 lbs 11 years 3 teaspoons (15 mL)

No Recall
Western Family Foods Inc

Acetaminophen | Western Family Foods Inc

this product does not contain directions or complete warnings for adult use do not give more than directed (see Liver warning) shake well before using find right dose on chart. If possible, use weight to dose; otherwise use age. use only enclosed syringe designed for use with this product. Do not use any other dosing device. remove bottle cap and insert syringe tip through opening at top of the bottle tip the bottle upside down and draw medicine into the syringe fill to dose level dispense liquid slowly into child’s mouth, toward inner cheek if needed, repeat dose every 4 hours while symptoms last do not give more than 5 times in 24 hours do not give for more than 5 days unless directed by a doctor replace cap tightly to maintain child resistance Dosing Chart Weight (lb) Age (yr) Dose (mL) under 24 under 2 years ask a doctor 24-35 2-3 years 5 mL
Attention: use only enclosed syringe specifically designed for use with this product. Do not use any other dosing device.

No Recall
Freds, Inc

Acetaminophen | Freds, Inc

Do Not take more than directed
(see overdose warning)
Adults and children 12 years and over:
take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours unless directed by a doctor do not take more than 10 days unless directed by a doctor
children under 12 years: ask a doctor

No Recall
Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals

Acetaminophen | Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals

Do not take more than directed AGE DOSE Adults and Children 12 years and over Take 2 tablets every 4 to 6 hours while symptoms last Do not take more than 12 tablets in 24 hours Children 6 to 11 years Take 1 tablet every 4 to 6 hours while symptoms last Do not take more than 5 tablets in 24 hours Children under 6 years Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals

Acetaminophen | Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals

Do not take more than directed (see overdose warning)

Adults and children 12 years and over:
take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours unless directed by a doctor do not take for more than 10 days unless directed by a doctor. Children under 12 years: ask a doctor.

No Recall
Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals

Acetaminophen | Gemini Pharmaceuticals, Inc. Dba Ondra Pharmaceuticals

Do not take more than directed (see overdose warning)

Adults and children 12 years and over:
take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours unless directed by a doctor do not take for more than 10 days unless directed by a doctor

Children under 12 years: ask a doctor

No Recall
Time Cap Laboratories, Inc

Acetaminophen | Time Cap Laboratories, Inc

Do not take more than directed (see overdosage warning)

Adults and children 12 years and over: take 2 tablets (1,000 mg) every 6 hours while symptoms last; do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor; do not take for more than 10 days unless directed by a doctor
Children under 12 years: Do not use this adult extra strength product in children under 12 years of age, this will provide more than the recommended dose (overdosage) of acetaminophen and may cause liver damage

No Recall
Freds, Inc

Acetaminophen | Freds, Inc

Do Not take more than directed
(see overdose warning)
Adults and children 12 years and over:
take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours unless directed by a doctor do not take more than 10 days unless directed by a doctor
Children under 12 years: ask a doctor

No Recall
Western Family Foods Inc

Acetaminophen | Western Family Foods Inc

do not use more than directed (see Liver warning)
adults and children
12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Physicians Total Care, Inc.

Acetaminophen | Physicians Total Care, Inc.

■ This products does not contain directions or complete warnings for adult use.
■ Find right dose on the chart below. If possible, use weight to dose; otherwise, use age.
■ Chew before swallowing
■ If needed, repeat dose every 4 hours while symptoms lasts
■ Do not give more than 5 times in 24 hours
■ Do not give for more than 5 days unless directed by a doctor.

Weight Age Tablets Under 24 lbs
Under 2 years
Ask a doctor
24-35 lbs
2-3 years
2 tablets
36-47 lbs
4-5 years
3 tablets
48-59 lbs
6-8 years
4 tablets
60-71 lbs
9-10 years
5 tablets
72-95 lbs
11 years
6 tablets

No Recall
Health Mart

Acetaminophen | Health Mart

do not take more than directed (see overdose warning) Adults take 2 caplets every 8 hours with water
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

No Recall
Rite Aid Corporation

Acetaminophen | Rite Aid Corporation

do not take more than directed (see Liver warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Nash-finch Company

Acetaminophen | Hyvee Inc

• do not use more than directed (see overdose warning) • take every 4 hours, while symptoms persist. Do not take more than 5 packets in 24 hours unless directed by a doctor.
Age

Dose

children under 4 years of age

do not use

children 4 to under 12 years of age

do not use unless directed by a doctor

adults and children 12 years of age and over

one packet
• dissolve contents of one packet into 8 oz. hot water: sip while hot. Consume entire drink within 10-15 minutes. • if using a microwave, add contents of one packet to 8 oz. of cool water: stir briskly before and after heating. Do not overheat.

No Recall
Family Dollar Services, Inc.

Acetaminophen | Family Dollar Services, Inc.

do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

No Recall
Safeway Inc.

Acetaminophen | Safeway Inc.

do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water
swallow whole - do not crush, chew or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor children under 18 years of age ask a doctor

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Acetaminophen | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Do not take more than the directed (see overdose warning)

Adults and children 12 years and over:
Take 2 tablets every 6 hours while symptoms last. Do not take more than 6 tablets in 24 hours unless directed by a doctor Do not take for more than 10 days unless directed by a doctor
Children under 12 years: Do not use adult Extra Strength product in children under 12 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Rebel Distributors Corp

Acetaminophen | Rebel Distributors Corp

this product does not contain directions or complete warnings for adult use

find correct does on chart below

if possible, use weight to dose, otherwise use age

chew tablets before swallowing

give dose every 4 hours while symptoms last

do not give more than 5 doses in 24 hours
Weight
(pounds) Age
(years) Dose
(tablets) 72 - 95 11 - 12 4 - 6 60 - 71 9 - 10 4 - 5 48 - 59 6 - 8 4 36 - 47 4 - 5 3 24 - 35 2 - 3 2 under 24 under 2 ask a doctor

No Recall
Rugby Laboratories Inc.

Acetaminophen | Rugby Laboratories Inc.

this product does not contain directions or complete warnings for adult use find correct dose below if possible use weight to dose, otherwise use age chew tablets before swallowing give dose every 4 hours while symptoms last do not give more than 5 doses in 24 hours Weight Age Dose 72 - 95 lbs 11-12 years 4 – 6 tablets 60 - 71 lbs 9 - 10 years 4 – 5 tablets 48 - 59 lbs 6 - 8 years 4 tablets 36 - 47 lbs 4 - 5 years 3 tablets 24 - 35 lbs 2 - 3 years 2 tablets under 24 lbs under 2 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 10 tablets in 24 hours do not use for more than 10 days unless directed by a doctor children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours do not use for more than 5 days unless directed by a doctor children under 6 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve do not take more than 6 caplets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last swallow whole – do not crush, chew, or dissolve do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 6 tablets in 24 hours, unless directed by a doctor do not use for more than 10 days unless directed by a doctor children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not to take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not to take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not use more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under
12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 6 hours do not take more than 8 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole - do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 10 caplets in 24 hours children under 12 years ask a doctor

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Aaa Pharmaceutical, Inc.

Acetaminophen | Aaa Pharmaceutical, Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 4 hours swallow whole – do not crush, chew, or dissolve do not take more than 12 caplets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Amerisource Bergen

Acetaminophen | Amerisource Bergen

do not take more than directed (see overdose warning) adults and children 12 years and over ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor children under 12 years ▪ do not use

No Recall
Walgreen Company

Acetaminophen | D.j.h. Inc

Apply product as needed.

No Recall
Cardinal Health

Acetaminophen | Cardinal Health

do not take more than directed (see overdose warning) adults ▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time.
▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 geltabs in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Amerisource Bergen

Acetaminophen | Amerisource Bergen

do not take more than directed (see overdose warning) adults ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Chain Drug Marketing Association Inc.

Acetaminophen | Chain Drug Marketing Association Inc.

do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

No Recall
Chain Drug Marketing Association Inc.

Acetaminophen | Chain Drug Marketing Association Inc.

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 caplets every 8 hours with water
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor children under 12 years do not use

No Recall
American Sales Company

Acetaminophen | American Sales Company

do not take more than directed (see overdose warning) adults ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Select Brand

Acetaminophen | Select Brand

adults take 2 caplets every 8 hours with water
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

No Recall
Fred’s Inc.

Acetaminophen | Fred's Inc.

do not take more than directed (see overdose warning) adults ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Cvs Pharmacy

Acetaminophen | Cvs Pharmacy

do not take more than directed (see overdose warning) adults take 2 caplets every 8 hours with water
swallow whole - do not crush, chew, split or dissolve
do not take more than 6 caplets in 24 hours
do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

No Recall
Walgreen Company

Acetaminophen | Neutrogena Corporation

cleanse skin thoroughly before applying this product cover the entire affected area with a thin layer one to three times daily because excessive drying of the skin may occur, start with one application daily, then gradually increase to two or three times daily if needed or as directed by a doctor if bothersome dryness or peeling occurs, reduce application to once a day or every other day.

No Recall
Walgreen Company

Acetaminophen | H E B

do not take more than the recommended dose (see overdose warning) adults and children 12 years and older: take 2 caplets with water repeat every 6 hours, as needed do not exceed 6 caplets per day children under 12 years: ask a doctor

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Acetaminophen | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Do Not Take More than Directed.

Adults and Children 12 years and over:

                            • Take 2 tablets every 4 to 6 hours while symptoms last.

                            • Do not take more than 12 tablets in 24 hours.

Children 6-11 years:

                            • Take 1 tablet every 4 to 6 hours while symptoms last.

                            • Do not take more than 5 tablet in 24 hours.

Children under 6 years:

                            • Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the     recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Acetaminophen | Ge Healthcare Inc.

2.1 CNS (Central Nervous System)
Adults: The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection.

Pediatric Patients (2-16 years): The recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) administered as a bolus intravenous injection [see Dosage and Administration (2.3)].
2.2 Body (Intrathoracic [noncardiac], Intra-abdominal, Pelvic and Retroperitoneal Regions)
Adult and Pediatric Patients (2-16 years of age): For imaging the kidney, the recommended dose of OMNISCAN is 0.1 mL/kg (0.05 mmol/kg). For imaging the intrathoracic (noncardiac), intra-abdominal, and pelvic cavities, the recommended dose of OMNISCAN is 0.2 mL/kg (0.1 mmol/kg) [see Dosage and Administration (2.3)].
2.3 Dosage Chart BODY WEIGHT PEDIATRIC ADULTS kg lb 0.05 0.1 0.05 0.1 (mmol/kg) (mmol/kg) VOLUME (mL) VOLUME (mL) * The heaviest patient in clinical studies weighed 136 kg. 12 26 1.2 2.4 - - 14 31 1.4 2.8 - - 16 35 1.6 3.2 - - 18 40 1.8 3.6 - - 20 44 2 4 - - 22 48 2.2 4.4 - - 24 53 2.4 4.8 - - 26 57 2.6 5.2 - - 28 62 2.8 5.6 - - 30 66 3 6 - - 40 88 4 8 4 8 50 110 5 10 5 10 60 132 6 12 6 12 70 154 7 14 7 14 80 176 8 16 8 16 90 198 - - 9 18 100 220 - - 10 20 110 242 - - 11 22 120 264 - - 12 24 130* 286 - - 13 26 2.4 Dosing Guidelines
Inspect OMNISCAN visually for particulate matter and discoloration before administration, whenever solution and container permit.

Do not use the solution if it is discolored or particulate matter is present.

Draw OMNISCAN into the syringe and use immediately. Discard any unused portion of OMNISCAN Injection.

To ensure complete delivery of the desired volume of contrast medium, follow the injection of OMNISCAN with a 5 mL flush of 0.9% sodium chloride. Complete the imaging procedure within 1 hour of administration of OMNISCAN.
2.5 Directions for Proper Use of OMNISCAN Pharmacy Bulk Package Use only a suitable work area, such as a laminar flow hood, to withdraw OMNISCAN Injection doses from the Pharmacy Bulk Package. Penetrate the Pharmacy Bulk Package container closure only once using a suitable transfer device and aseptic technique. Once the closure is penetrated, withdraw the container contents without delay. If delay is unavoidable, complete the fluid transfer as soon as possible within a maximum time of 8 hours. Once the closure is penetrated, keep the Pharmacy Bulk Package container in the aseptic area and at room temperature (do not exceed 30ºC). Following withdrawal of any dose from the Pharmacy Bulk Package, immediately label the dose with the supplied peel-off label that identifies the dose contents as OMNISCAN and that OMNISCAN is not for intrathecal use. Use each individual dose of OMNISCAN Injection immediately following withdrawal from the Pharmacy Bulk Package container; discard any unused portion of the OMNISCAN Injection dose not used immediately. Discard any unused OMNISCAN doses remaining in the Pharmacy Bulk Package 8 hours after the penetration of the container closure.

No Recall
Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Acetaminophen | Ncs Healthcare Of Ky, Inc Dba Vangard Labs

Do Not Take More than Directed.

Adults and Children 12 years and over: Take 2 tablets every 4 to 6 hours whild symptoms last. Do not take more than 12 tablets in 24 hours.

Children 6-11 years: Take 1 tablet every 4 to 6 hours while symptoms last. Do not take more than 5 tablet in 24 hours.

Children under 6 years: Do not use adult Regular Strength products in children under 6 years of age; this will provide more than the recommended dose (overdose) of acetaminophen and may cause liver damage.

No Recall
Advance Pharmaceutical Inc.

Acetaminophen | Advance Pharmaceutical Inc.

adults and children 12 years and over 1-2 tablets every 4 hours or 2-3 tablets every 6 hours while symptoms last, not more than 12 tablets in 24 hours children 6 to 11 years 1 tablet every 4 hours while symptoms last, not more than 5 tablets in 24 hours children under 6 years ask a doctor

No Recall
Medline Industries, Inc.

Acetaminophen | Medline Industries, Inc.

do not take more than directed (see overdose warning) adults ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Shopko Stores Operating Co., Llc

Acetaminophen | Shopko Stores Operating Co., Llc

do not take more than directed (see overdose warning) adults ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ask a doctor

No Recall
Bonita Pharmaceuticals Llc

Acetaminophen | Bonita Pharmaceuticals Llc

Do not take more than directed (see overdose warning)
Adults and children 12 years and over:
take 2 caplets every 6 hours while symptoms last do not take more than 6 caplets in 24 hours unless directed by a doctor do not take for more than 10 days unless directed by a doctor
Children under 12years: ask a doctor

No Recall
Ohm Laboratories Inc.

Acetaminophen | Ohm Laboratories Inc.

do not take more than directed (see overdose warning) adults ▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time.
▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 geltabs in 24 hours
▪ do not use for more than 10 days unless directed by a doctor
under 18 years of age ▪ ask a doctor

No Recall
Humanwell Puracap Pharmaceutical (Wuhan), Ltd.

Acetaminophen | Humanwell Puracap Pharmaceutical (wuhan), Ltd.

Do not take more than directed
(see overdose warning)

Adults and children 12 years and over
take 2 softgels every 4 to 6 hours while symptoms last do not take more than 10 softgels in 24 hours do not use for more than 10 days unless directed by a doctor
Children 6-11 years
take 1 softgel every 4 to 6 hours while symptoms last do not take more than 5 softgels 24 hours do not use for more than 5 days unless directed by a doctorr
children under 6 years
ask a doctor

No Recall
Kareway Product, Inc.

Acetaminophen | Kareway Product, Inc.

do not take more than directed (see overdose warning)
adults and children 12 years and over
take 2 tablets every 4 to 6 house as needed do not take more than 8 tablets in 24 hours do not use for more than 10 days unless directed by a doctor

children under 12 years
do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Wal-mart Stores, Inc

Acetaminophen | Wal-mart Stores, Inc

do not take more than directed (see overdose warning) adults ▪ take 2 geltabs every 8 hours. Swallow only one geltab at a time.
▪ take a sip of water before swallowing each geltab and wash each geltab down with water (up to a full 8 oz. glass).
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 geltabs in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Velocity Pharma

Acetaminophen | Velocity Pharma

do not take more than directed (see overdose warning). Adults and children 12 years and over: take 2 caplets every 6 hours while symptoms last. do not take more than 6 caplets of this product in 24 hours, unless directed by a doctor do not take for more than 10 days unless directed by a doctor
children under 12 years:
Ask a doctor

No Recall
Supervalu Inc.

Acetaminophen | Supervalu Inc.

do not take more than directed (see overdose warning) adults ▪ take 2 caplets every 8 hours with water
▪ swallow whole - do not crush, chew, split or dissolve
▪ do not take more than 6 caplets in 24 hours
▪ do not use for more than 10 days unless directed by a doctor under 18 years of age ▪ ask a doctor

No Recall
Apotheca, Inc

Acetaminophen | Apotheca, Inc

Directions
do not take more than directed (see overdose warning).

Adults and children 12 years and over

Take 2 tablets every 4 to 6 while symptoms last.
Do not take more than 12 tablets in 24 hours.

Children 6 to under 12 years

Take 1 tablet every 4 to 6 while symptoms last.
Do not take more than 5 tablets in 24 hours.

Children under 6 years

Do not use adult regular strength products in childern under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage.

Other information
Tamper Evident: do not use if imprinted safety seal under cap is broken or missing store between 20-25°C (68-77°F) use by expiration date on package

No Recall
Rite Aid Corporation

Acetaminophen | Pharmaceutical Associates, Inc.

Adults and children 12 years of age and over
5 mL (teaspoonful) of the syrup every four to six hours as needed; do not exceed 6 teaspoonfuls in 24 hours.
Children 6 to 12 years of age
2.5 mL (1/2 teaspoonful) of the syrup every four to six hours as needed; do not exceed 3 teaspoonfuls in 24 hours.

No Recall
Rite Aid Corporation

Acetaminophen | Proficient Rx Lp

Epilepsy

In the controlled add-on trials, no correlation has been demonstrated between trough plasma concentrations of topiramate and clinical efficacy. No evidence of tolerance has been demonstrated in humans. Doses above 400 mg/day (600, 800, or 1000 mg/day) have not been shown to improve responses in dose-response studies in adults with partial onset seizures.

It is not necessary to monitor topiramate plasma concentrations to optimize Topiramate therapy. On occasion, the addition of Topiramate to phenytoin may require an adjustment of the dose of phenytoin to achieve optimal clinical outcome. Addition or withdrawal of phenytoin and/or carbamazepine during adjunctive therapy with Topiramate may require adjustment of the dose of Topiramate. Because of the bitter taste, tablets should not be broken.

Topiramate can be taken without regard to meals.

Monotherapy Use

The recommended dose for topiramate monotherapy in adults and children 10 years of age and older is 400 mg/day in two divided doses. Approximately 58% of patients randomized to 400 mg/day achieved this maximal dose in the monotherapy controlled trial; the mean dose achieved in the trial was 275 mg/day. The dose should be achieved by titrating according to the following schedule:

Morning Dose

Evening Dose

Week 1

25 mg

25 mg

Week 2

50 mg

50 mg

Week 3

75 mg

75 mg

Week 4

100 mg

100 mg

Week 5

150 mg

150 mg

Week 6

200 mg

200 mg

Adjunctive Therapy Use

Adults (17 Years of Age and Over) - Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of Topiramate as adjunctive therapy in adults with partial seizures is 200-400 mg/day in two divided doses, and 400 mg/day in two divided doses as adjunctive treatment in adults with primary generalized tonic-clonic seizures. It is recommended that therapy be initiated at 25-50 mg/day followed by titration to an effective dose in increments of 25-50 mg/week. Titrating in increments of 25 mg/week may delay the time to reach an effective dose. Daily doses above 1,600 mg have not been studied.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose was reached at the end of 8 weeks (see CLINICAL STUDIES, Adjunctive Therapy Controlled Trials in Patients With Primary Generalized Tonic-Clonic Seizures).

Pediatric Patients (Ages 2 - 16 Years) - Partial Seizures, Primary Generalized Tonic-Clonic Seizures, or Lennox-Gastaut Syndrome

The recommended total daily dose of Topiramate as adjunctive therapy for patients with partial seizures, primary generalized tonic-clonic seizures, or seizures associated with Lennox-Gastaut Syndrome is approximately 5 to 9 mg/kg/day in two divided doses. Titration should begin at 25 mg (or less, based on a range of 1 to 3 mg/kg/day) nightly for the first week. The dosage should then be increased at 1- or 2-week intervals by increments of 1 to 3 mg/kg/day (administered in two divided doses), to achieve optimal clinical response. Dose titration should be guided by clinical outcome.

In the study of primary generalized tonic-clonic seizures the initial titration rate was slower than in previous studies; the assigned dose of 6 mg/kg/day was reached at the end of 8 weeks (see CLINICAL STUDIES, Adjunctive Therapy Controlled Trial in Patients With Primary Generalized Tonic-Clonic Seizures).

Patients with Renal Impairment:

In renally impaired subjects (creatinine clearance less than 70 mL/min/1.73m2), one half of the usual adult dose is recommended. Such patients will require a longer time to reach steady-state at each dose.

Geriatric Patients (Ages 65 Years and Over):

Dosage adjustment may be indicated in the elderly patient when impaired renal function (creatinine clearance rate ≤70 mL/min/1.73 m2) is evident (see DOSAGE AND ADMINISTRATION:Patients with Renal Impairment and CLINICAL PHARMACOLOGY:Special Populations:Age, Gender, and Race).

Patients Undergoing Hemodialysis:

Topiramate is cleared by hemodialysis at a rate that is 4 to 6 times greater than a normal individual. Accordingly, a prolonged period of dialysis may cause topiramate concentration to fall below that required to maintain an anti-seizure effect. To avoid rapid drops in topiramate plasma concentration during hemodialysis, a supplemental dose of topiramate may be required. The actual adjustment should take into account 1) the duration of dialysis period, 2) the clearance rate of the dialysis system being used, and 3) the effective renal clearance of topiramate in the patient being dialyzed.

Patients with Hepatic Disease:

In hepatically impaired patients topiramate plasma concentrations may be increased. The mechanism is not well understood.

No Recall
Kroger Company

Acetaminophen | Asclemed Usa, Inc.

Adult:
The maximum recommended single dose of Lidocaine Hydrochloride Oral Topical Solution, USP (Viscous) 2% for healthy adults should be such that the dose of lidocaine HCI does not exceed 4.5 mg/kg or 2 mg/lb body weight and does not in any case exceed a total of 300 mg.

For symptomatic treatment of irritated or inflamed mucous membranes of the mouth and pharynx, the usual adult dose is one 15 mL tablespoonful undiluted. For use in the mouth, the solution should be swished around in the mouth and spit out. For use in the pharynx, the undiluted solution should be gargled and may be swallowed. This dose should not be administered at intervals of less than three hours, and not more than eight doses should be given in a 24-hour period.

The dosage should be adjusted commensurate with the patient's age, weight and physical condition. (See PRECAUTIONS).
Pediatric:
Care must be taken to ensure correct dosage in all pediatric patients as there have been cases of overdose due to inappropriate dosing.

It is difficult to recommend a maximum dose of any drug for children since this varies as a function of age and weight. For children over 3 years of age who have a normal lean body mass and normal body development, the maximum dose is determined by the child's weight or age. For example: in a child of 5 years weighing 50 lbs., the dose of lidocaine hydrochloride should not exceed 75-100 mg (3/4 to 1 teaspoonful).

For infants and in children under 3 years of age, 1/4 teaspoonful of the solution should be accurately measured and applied to the immediate area with a cotton-tipped applicator. This dose should not be administered at intervals of less than three hours. Not more than four doses should be given in a 12-hour period.

Remove one stick at a time. Swab mouth as needed. Discard stick after single use.

No Recall
Kroger Company

Acetaminophen | Medicis Pharmaceutical Corp.

For topical use only. LUZU Cream, 1% is not for ophthalmic, oral, or intravaginal use.
When treating interdigital tinea pedis, a thin layer of LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for two (2) weeks. When treating tinea cruris or tinea corporis, LUZU Cream, 1% should be applied to the affected area and approximately 1 inch of the immediate surrounding area(s) once daily for one (1) week.

No Recall
Mckesson Packaging Services Business Unit Of Mckesson Corporation

Acetaminophen | Mckesson Packaging Services Business Unit Of Mckesson Corporation

Directions

Adults and children 12 years of age and older
• take 2 tablets every 4 to 6 hours as needed. Do not take more than 12 tablets in 24 hours.

Children 6-11 years of age
• Take 1 tablet every 4 to 6 hours as needed. Do not take more than 5 tablets in 24 hours.

Children under 6 years of age
• Do not use this regular strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.

No Recall
Mckesson

Acetaminophen | Mckesson

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours children under 6 years do not use this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Cardinal Health

Acetaminophen | Major Pharmaceuticals

Dosage should be individualized for maximum beneficial effect. While the usual daily dosages given below will meet the needs of most patients, there will be some who may require higher doses. In such cases dosage should be increased cautiously to avoid adverse effects.
ADULTS: USUAL DAILY DOSE: Management of Anxiety Disorders and relief of Symptoms of Anxiety. Depending on severity of symptoms - 2 mg to 10 mg, 2 to 4 times daily Symptomatic Relief in Acute Alcohol Withdrawal. 10 mg, 3 or 4 times during the first 24 hours, reducing to 5 mg, 3 or 4 times daily as needed Adjunctively for Relief of Skeletal Muscle Spasm. 2 mg to 10 mg, 3 or 4 times daily Adjunctively in Convulsive Disorders. 2 mg to 10 mg, 2 to 4 times daily Geriatric Patients, or in the presence of debilitating
disease. 2 mg to 2.5 mg, 1 or 2 times daily initially; increase gradually as needed and tolerated PEDIATRIC PATIENTS: Because of varied responses to CNS-acting drugs, initiate therapy with lowest dose and increase as required. Not for use in children under 6 months. 1 mg to 2.5 mg, 3 or 4 times daily initially; increase gradually as needed and tolerated

No Recall
Mckesson

Acetaminophen | Mckesson

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 8 tablets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Mckesson

Acetaminophen | Mckesson

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 6 hours while symptoms last do not take more than 8 tablets in 24 hours children under 12 years do not use this adult product in children under 12 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Mckesson

Acetaminophen | Mckesson

do not take more than directed (see overdose warning) adults and children 12 years and over take 2 tablets every 4 to 6 hours while symptoms last do not take more than 12 tablets in 24 hours children 6-11 years take 1 tablet every 4 to 6 hours while symptoms last do not take more than 5 tablets in 24 hours children under 6 years do not use this adult product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage

No Recall
Kroger Company

Acetaminophen | Pharmaderm A Division Of Fougera Pharmaceuticals Inc.

Apply a thin layer of Temovate® E to the affected skin areas twice daily and rub in gently and completely. Wash hands after each application.

Temovate® E is a super-high potency topical corticosteroid; therefore, treatment should be limited to 2 consecutive weeks, and amounts greater than 50 grams per week should not be used.

In moderate to severe plaque-type psoriasis, Temovate® E applied to 5% to 10% of body surface area can be used for up to 4 weeks. The total dosage should not exceed 50 grams per week. When dosing for more than 2 weeks, any additional benefits of extending treatment should be weighed against the risk of HPA suppression. Therapy should be discontinued when control has been achieved. If no improvement is seen within 2 weeks, reassessment of diagnosis may be necessary. Treatment beyond 4 consecutive weeks is not recommended.

Temovate® E should not be used with occlusive dressings.

No Recall
Agile Pharmachem

Acetaminophen | Sicos Et Cie

For sunscreen use:

● shake well before use

● apply liberally 15 minutes before sun exposure

● reapply at least every 2 hours

● use a water resistant sunscreen if swimming or sweating

● Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including:

● limit time in the sun, especially from 10 a.m. – 2 p.m.

● wear long-sleeved shirts, pants, hats, and sunglasses

● children under 6 months of age: Ask a doctor

No Recall
Agile Pharmachem

Acetaminophen | It Cosmetics, Llc

There is currently no dosage information available for this product. We apologize for any inconvenience.

No Recall
Kroger Company

Acetaminophen | Kroger Company

• do not take more than directed (see Liver warning)
adults and children 12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under 12 years

ask a doctor

No Recall
Supervalu Inc.

Acetaminophen | Cardinal Health

2.1 Recommended Dosing Schedule
PROTONIX is supplied as delayed-release granules in packets for preparation of oral suspensions or as delayed-release tablets. The recommended dosages are outlined in Table 1.
Table 1: Recommended Dosing Schedule for PROTONIX Indication Dose Frequency * For adult patients who have not healed after 8 weeks of treatment, an additional 8-week course of PROTONIX may be considered. † Controlled studies did not extend beyond 12 months ‡ Dosage regimens should be adjusted to individual patient needs and should continue for as long as clinically indicated. Doses up to 240 mg daily have been administered.
Short-Term Treatment of Erosive Esophagitis Associated With GERD

  Adults

40 mg

Once daily for up to 8 weeks*

  Children (5 years and older)

    ≥ 15 kg to < 40 kg

20 mg

Once daily for up to 8 weeks

    ≥ 40 kg

40 mg

Maintenance of Healing of Erosive Esophagitis

  Adults

40 mg

Once daily†

Pathological Hypersecretory Conditions Including Zollinger-Ellison Syndrome

  Adults

40 mg

Twice daily‡
2.2 Administration Instructions
Directions for method of administration for each dosage form are presented in Table 2.
Table 2: Administration Instructions Formulation Route Instructions* * Patients should be cautioned that PROTONIX Delayed-Release Tablets and PROTONIX For Delayed-Release Oral Suspension should not be split, chewed, or crushed.
Delayed-Release Tablets

Oral

Swallowed whole, with or without food

For Delayed-Release Oral Suspension

Oral

Administered in 1 teaspoonful of applesauce or apple juice approximately 30 minutes prior to a meal

For Delayed-Release Oral Suspension

Nasogastric tube

See instructions below

PROTONIX Delayed-Release Tablets

PROTONIX Delayed-Release Tablets should be swallowed whole, with or without food in the stomach. If patients are unable to swallow a 40 mg tablet, two 20 mg tablets may be taken. Concomitant administration of antacids does not affect the absorption of PROTONIX Delayed-Release Tablets.

PROTONIX For Delayed-Release Oral Suspension

PROTONIX For Delayed-Release Oral Suspension should only be administered approximately 30 minutes prior to a meal via oral administration in apple juice or applesauce or nasogastric tube in apple juice only. Because proper pH is necessary for stability, do not administer PROTONIX For Delayed-Release Oral Suspension in liquids other than apple juice, or foods other than applesauce.

Do not divide the 40 mg PROTONIX For Delayed-Release Oral Suspension packet to create a 20 mg dosage for pediatric patients who are unable to take the tablet formulation.

PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Applesauce
• Open packet. • Sprinkle granules on one teaspoonful of applesauce. DO NOT USE OTHER FOODS OR CRUSH OR CHEW THE GRANULES. • Take within 10 minutes of preparation. • Take sips of water to make sure granules are washed down into the stomach. Repeat water sips as necessary.
PROTONIX For Delayed-Release Oral Suspension - Oral Administration in Apple Juice
• Open packet. • Empty granules into a small cup or teaspoon containing one teaspoon of apple juice. • Stir for 5 seconds (granules will not dissolve) and swallow immediately. • To make sure that the entire dose is taken, rinse the container once or twice with apple juice to remove any remaining granules. Swallow immediately.
PROTONIX For Delayed-Release Oral Suspension - Nasogastric (NG) Tube or Gastrostomy Tube Administration

For patients who have a nasogastric tube or gastrostomy tube in place, PROTONIX For Delayed-Release Oral Suspension can be given as follows:
• Remove the plunger from the barrel of a 2 ounce (60 mL) catheter-tip syringe. Discard the plunger. • Connect the catheter tip of the syringe to a 16 French (or larger) tube. • Hold the syringe attached to the tubing as high as possible while giving PROTONIX For Delayed-Release Oral Suspension to prevent any bending of the tubing. • Empty the contents of the packet into the barrel of the syringe. • Add 10 mL (2 teaspoonfuls) of apple juice and gently tap and/or shake the barrel of the syringe to help rinse the syringe and tube. Repeat at least twice more using the same amount of apple juice (10 mL or 2 teaspoonfuls) each time. No granules should remain in the syringe.

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Kroger Company

Acetaminophen | Select Brand Dist.

clean affected area apply small amount of this product on the area 1-3 times daily may be covered with a sterile bandage if bandaged, let dry first

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Perrigo New York Inc

Acetaminophen | Procter & Gamble Manufacturing Company

apply liberally 15 minutes before sun exposure reapply at least every 2 hours use water resistant sunscreen if swimming or sweating Sun Protection Measures. Spending time in the sun increases your risk of skin cancer and early skin aging. To decrease this risk, regularly use a sunscreen with a Broad Spectrum SPF value of 15 or higher and other sun protection measures including: limit time in sun, especially from 10 a.m. - 2 p.m. wear long-sleeved shirts, pants, hats, and sunglasses children under 6 months: ask a doctor

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Kroger Company

Acetaminophen | Basiem

There is currently no dosage information available for this product. We apologize for any inconvenience.

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Kroger Company

Acetaminophen | Citron Pharma Llc

Clarithromycin tablets may be given with or without food.

Clarithromycin may be administered without dosage adjustment in the presence of hepatic impairment if there is normal renal function. In patients with severe renal impairment (CLCR < 30 mL/min), the dose of clarithromycin should be reduced by 50%. However, when patients with moderate or severe renal impairment are taking clarithromycin concomitantly with atazanavir or ritonavir, the dose of clarithromycin should be reduced by 50% or 75% for patients with CLCR of 30 to 60 mL/min or < 30 mL/min, respectively.

ADULT DOSAGE GUIDELINES Clarithromycin Tablets Infection Dosage
(q 12 h) Duration
(Days) Pharyngitis/Tonsillitis due to

     S. pyogenes 250 mg
10
Acute maxillary sinusitis due to
500 mg
14
     H. influenzae

     M. catarrhalis

     S. pneumoniae

Acute exacerbation of chronic bronchitis due to

     H. influenzae 500 mg
7 to 14
     H. parainfluenzae
500 mg
7
     M. catarrhalis
250 mg
7 to 14
     S. pneumoniae
250 mg
7 to 14
Community-Acquired Pneumonia due to

     H. influenzae 250 mg
7
     H. parainfluenzae
-
-
     M. catarrhalis
-
-
     S. pneumoniae
250 mg
7 to 14
     C. pneumoniae
250 mg
7 to 14
     M. pneumoniae
250 mg
7 to 14
Uncomplicated skin and skin structure
250 mg
7 to 14
     S. aureus

     S. pyogenes

H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence

Triple therapy: clarithromycin/lansoprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 30 mg lansoprazole, and 1 gram amoxicillin, all given twice daily (q 12 h) for 10 or 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Triple therapy: clarithromycin/omeprazole/amoxicillin

The recommended adult dose is 500 mg clarithromycin, 20 mg omeprazole, and 1 gram amoxicillin, all given twice daily (q 12 h) for 10 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). In patients with an ulcer present at the time of initiation of therapy, an additional 18 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/omeprazole

The recommended adult dose is 500 mg clarithromycin given three times daily (q 8 h) and 40 mg omeprazole given once daily (qAM) for 14 days (see INDICATIONS AND USAGE and CLINICAL STUDIES sections). An additional 14 days of omeprazole 20 mg once daily is recommended for ulcer healing and symptom relief.

Dual therapy: clarithromycin/ranitidine bismuth citrate

The recommended adult dose is 500 mg clarithromycin given twice daily (q 12 h) or three times daily (q 8 h) and 400 mg ranitidine bismuth citrate given twice daily (q 12 h) for 14 days. An additional 14 days of 400 mg twice daily is recommended for ulcer healing and symptom relief. Clarithromycin and ranitidine bismuth citrate combination therapy is not recommended in patients with creatinine clearance less than 25 mL/min (see INDICATIONS AND USAGE and CLINICAL STUDIES sections).

Children

The usual recommended daily dosage is 15 mg/kg/day divided q 12 h for 10 days.

PEDIATRIC DOSAGE GUIDELINES Based on Body Weight Dosing Calculated on 7.5 mg/kg q 12 h Weight Dose Kg lbs (q 12 h) 9
20
62.5 mg
17
37
125 mg
25
55
187.5 mg
33
73
250 mg
Mycobacterial Infections

Prophylaxis

The recommended dose of clarithromycin for the prevention of disseminated Mycobacterium avium disease is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. No studies of clarithromycin for MAC prophylaxis have been performed in pediatric populations and the doses recommended for prophylaxis are derived from MAC treatment studies in children. Dosing recommendations for children are in the table above.

Treatment

Clarithromycin is recommended as the primary agent for the treatment of disseminated infection due to Mycobacterium avium complex. Clarithromycin should be used in combination with other antimycobacterial drugs that have shown in vitro activity against MAC or clinical benefit in MAC treatment (see CLINICAL STUDIES). The recommended dose for mycobacterial infections in adults is 500 mg b.i.d. In children, the recommended dose is 7.5 mg/kg b.i.d. up to 500 mg b.i.d. Dosing recommendations for children are in the table above.

Clarithromycin therapy should continue if clinical response is observed. Clarithromycin can be discontinued when the patient is considered at low risk of disseminated infection.

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Preferred Pharmaceuticals, Inc.

Acetaminophen | Preferred Pharmaceuticals, Inc.

Do not take more than directed (see overdose warning)

Adults and children 12 years and over:
• take 2 tablets every 6 hours while symptoms last • do not take more than 6 tablets in 24 hours unless directed by a doctor • do not take for more than 10 days unless directed by a doctor.
Children under 12 years: ask a doctor.

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Cardinal Health

Acetaminophen | Upsher-smith Laboratories, Inc.

2.1 Adults
The usual initial antihypertensive oral dose of amlodipine besylate tablets is 5 mg once daily, and the maximum dose is 10 mg once daily.

Small, fragile, or elderly patients, or patients with hepatic insufficiency may be started on 2.5 mg once daily and this dose may be used when adding amlodipine besylate tablets to other antihypertensive therapy.

Adjust dosage according to blood pressure goals. In general, wait 7 to 14 days between titration steps. Titrate more rapidly, however, if clinically warranted, provided the patient is assessed frequently.

Angina: The recommended dose for chronic stable or vasospastic angina is 5 to 10 mg, with the lower dose suggested in the elderly and in patients with hepatic insufficiency. Most patients will require 10 mg for adequate effect.

Coronary artery disease: The recommended dose range for patients with coronary artery disease is 5 to 10 mg once daily. In clinical studies, the majority of patients required 10 mg [see Clinical Studies (14.4)].
2.2 Children
The effective antihypertensive oral dose in pediatric patients ages 6 to 17 years is 2.5 mg to 5 mg once daily. Doses in excess of 5 mg daily have not been studied in pediatric patients [see Clinical Pharmacology (12.4), Clinical Studies (14.1)].

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Cardinal Health

Acetaminophen | Genentech, Inc.

2.1 Administration
Administer only as an Intravenous Infusion [see Dosage and Administration (2.7)].

Do not administer as an intravenous push or bolus.

Premedicate before each infusion [see Dosage and Administration (2.7)].

Rituxan should only be administered by a healthcare professional with appropriate medical support to manage severe infusion reactions that can be fatal if they occur [see Warnings and Precautions (5.1)].
First Infusion: Initiate infusion at a rate of 50 mg/hr. In the absence of infusion toxicity, increase infusion rate by 50 mg/hr increments every 30 minutes, to a maximum of 400 mg/hr. Subsequent Infusions:
Standard Infusion: Initiate infusion at a rate of 100 mg/hr. In the absence of infusion toxicity, increase rate by 100 mg/hr increments at 30-minute intervals, to a maximum of 400 mg/hr.
For previously untreated follicular NHL and DLBCL patients:
If patients did not experience a Grade 3 or 4 infusion related adverse event during Cycle 1, a 90-minute infusion can be administered in Cycle 2 with a glucocorticoid-containing chemotherapy regimen. Initiate at a rate of 20% of the total dose given in the first 30 minutes and the remaining 80% of the total dose given over the next 60 minutes. If the 90-minute infusion is tolerated in Cycle 2, the same rate can be used when administering the remainder of the treatment regimen (through Cycle 6 or 8). Patients who have clinically significant cardiovascular disease or who have a circulating lymphocyte count ≥5000/mm3 before Cycle 2 should not be administered the 90-minute infusion [see Clinical Studies (14.4)]. Interrupt the infusion or slow the infusion rate for infusion reactions [see Boxed Warning, Warnings and Precautions (5.1)]. Continue the infusion at one-half the previous rate upon improvement of symptoms. 2.2 Recommended Dose for Non-Hodgkin's Lymphoma (NHL)
The recommended dose is 375 mg/m2 as an intravenous infusion according to the following schedules:
Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 or 8 doses. Retreatment for Relapsed or Refractory, Low-Grade or Follicular, CD20-Positive, B-Cell NHL
Administer once weekly for 4 doses. Previously Untreated, Follicular, CD20-Positive, B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy, for up to 8 doses. In patients with complete or partial response, initiate Rituxan maintenance eight weeks following completion of Rituxan in combination with chemotherapy. Administer Rituxan as a single-agent every 8 weeks for 12 doses. Non-progressing, Low-Grade, CD20-Positive, B-cell NHL, after first-line CVP chemotherapy
Following completion of 6–8 cycles of CVP chemotherapy, administer once weekly for 4 doses at 6-month intervals to a maximum of 16 doses. Diffuse Large B-Cell NHL
Administer on Day 1 of each cycle of chemotherapy for up to 8 infusions. 2.3 Recommended Dose for Chronic Lymphocytic Leukemia (CLL)
The recommended dose is:
375 mg/m2 the day prior to the initiation of FC chemotherapy, then 500 mg/m2 on Day 1 of cycles 2–6 (every 28 days). 2.4 Recommended Dose as a Component of Zevalin® for treatment of NHL Infuse rituximab 250 mg/m2 within 4 hours prior to the administration of Indium-111-(In-111-) Zevalin and within 4 hours prior to the administration of Yttrium-90- (Y-90-) Zevalin. Administer Rituxan and In-111-Zevalin 7–9 days prior to Rituxan and Y-90- Zevalin. Refer to the Zevalin package insert for full prescribing information regarding the Zevalin therapeutic regimen. 2.5 Recommended Dose for Rheumatoid Arthritis (RA) Administer Rituxan as two-1000 mg intravenous infusions separated by 2 weeks. Glucocorticoids administered as methylprednisolone 100 mg intravenous or its equivalent 30 minutes prior to each infusion are recommended to reduce the incidence and severity of infusion reactions. Subsequent courses should be administered every 24 weeks or based on clinical evaluation, but not sooner than every 16 weeks. Rituxan is given in combination with methotrexate. 2.6 Recommended Dose for Granulomatosis with Polyangiitis (GPA) (Wegener's Granulomatosis) and Microscopic Polyangiitis (MPA) Administer Rituxan as a 375 mg/m2 intravenous infusion once weekly for 4 weeks. Glucocorticoids administered as methylprednisolone 1000 mg intravenously per day for 1 to 3 days followed by oral prednisone 1 mg/kg/day (not to exceed 80 mg/day and tapered per clinical need) are recommended to treat severe vasculitis symptoms. This regimen should begin within 14 days prior to or with the initiation of Rituxan and may continue during and after the 4 week course of Rituximab treatment. Safety and efficacy of treatment with subsequent courses of Rituxan have not been established [see Warnings and Precautions (5.14)]. 2.7 Recommended Concomitant Medications
Premedicate before each infusion with acetaminophen and an antihistamine. For patients administered Rituxan according to the 90-minute infusion rate, the glucocorticoid component of their chemotherapy regimen should be administered prior to infusion [see Clinical Studies (14.4)].

For RA patients, methylprednisolone 100 mg intravenously or its equivalent is recommended 30 minutes prior to each infusion.

For GPA and MPA patients, glucocorticoids are given in combination with Rituxan [see Dosage and Administration (2.6)].

Pneumocystis jiroveci pneumonia (PCP) and anti-herpetic viral prophylaxis is recommended for patients with CLL during treatment and for up to 12 months following treatment as appropriate.

PCP prophylaxis is also recommended for patients with GPA and MPA during treatment and for at least 6 months following the last Rituxan infusion.
2.8 Preparation for Administration
Use appropriate aseptic technique. Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration. Do not use vial if particulates or discoloration is present. Withdraw the necessary amount of Rituxan and dilute to a final concentration of 1 mg/mL to 4 mg/mL in an infusion bag containing either 0.9% Sodium Chloride, USP, or 5% Dextrose in Water, USP. Gently invert the bag to mix the solution. Do not mix or dilute with other drugs. Discard any unused portion left in the vial.

Rituxan solutions for infusion may be stored at 2°C–8°C (36°F–46°F) for 24 hours. Rituxan solutions for infusion have been shown to be stable for an additional 24 hours at room temperature. However, since Rituxan solutions do not contain a preservative, diluted solutions should be stored refrigerated (2°C–8°C). No incompatibilities between Rituxan and polyvinylchloride or polyethylene bags have been observed.

No Recall
Kroger Company

Acetaminophen | Kroger Company

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 caplets every 6 hours while symptoms last • do not take more than 6 caplets in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctor
children under

12 years

ask a doctor

No Recall
Preferred Pharmaceuticals Inc.

Acetaminophen | Preferred Pharmaceuticals Inc.

The usual adult dosage is two (2) Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than two (2) capsules should be taken in a 4-hour period. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.

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Medsource Pharmaceuticals

Acetaminophen | Medsource Pharmaceuticals

The usual adult dosage is two (2) Acetaminophen, Caffeine, and Dihydrocodeine Bitartrate capsules orally every four (4) hours, as needed. Dosage should be adjusted according to the severity of the pain and the response of the patient. No more than two (2) capsules should be taken in a 4-hour period. No more than five (5) doses, or ten (10) capsules should be taken in a 24-hour period.

No Recall