Allergy Relief

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Allergy Relief Recall

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Side Effects & Adverse Reactions

Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy

Ask a doctor before use if you have • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis

Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

When using this product • marked drowsiness may occur • avoid alcoholic drinks • excitability may occur, especially in children • alcohol, sedatives and tranquilizers may increase drowsiness • be careful when driving a motor vehicle or operating machinery

If pregnant or breast-feeding,

ask a health professional before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away. {1-800-222-1222}

Do not use • with any other product containing diphenhydramine, even one used on skin • to make a child sleepy Ask a doctor before use if you have • glaucoma • trouble urinating due to an enlarged prostate gland • a breathing problem such as emphysema or chronic bronchitis Ask a doctor or pharmacist before use if you are

taking sedatives or tranquilizers

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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

• temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: • runny nose • sneezing • itchy, watery eyes • itchy nose or throat • temporarily relieves these symptoms of the common cold: • runny nose • sneezing

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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

Allergy Relief Manufacturers

Cvs Pharmacy

Allergy Relief | Cvs Pharmacy

• take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over

1 or 2 tablets

children 6 to under 12 years of age

1 tablet

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

No Recall
Chain Drug Consortium

Allergy Relief | Chain Drug Consortium

adults and children 12
years of age and over
1 tablet every 4 to 6 hours. Do
not take more than 6 tablets in
24 hours. children 6 to under 12
years of age 1/2 tablet (break tablet in half)
every 4 to 6 hours. Do not
exceed 3 whole tablets in 24
hours. children under 6 years of
age do not use this product in
children under 6 years of age

No Recall
Ohm Pharma Inc.

Allergy Relief | Kinetic Technologies

SHAKE WELL BEFORE USE. Spray directly onto the affected skin area(s). If necessary, part the hair to ensure direct contact with the skin. Rub in well. May be used daily or as directed by veterinarian.

No Recall
Dolgencorp, Inc. (Dollar General & Rexall)

Allergy Relief | Dolgencorp, Inc. (dollar General & Rexall)

take every 4 to 6 hours do not more than 6 doses in 24 hours adults and children 12 years of age and over take 1 to 2 tablets children 6 to under 12 years of age take 1 tablet children under 6 years of age do not use this product in children under 6

No Recall
H E B

Allergy Relief | W.s. Badger Company, Inc.

For full protection, apply liberally (2mg/cm2 of skin) to all exposed skin 15 minutes before sun exposure, then rub in to reduce whitening effect.
Reapply:
After 40 minutes of swimming or sweating Immediately after towel drying At least every 2 hours
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 10am-2pm Wear long-sleeved shirts, pants, hats, and sunglasses For children under 6 months of age: ask a doctor.

No Recall
Harmon Stores

Allergy Relief | Harmon Stores

adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Hyvee Inc

Allergy Relief | Hyvee Inc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Meijer Distribution Inc

Allergy Relief | Meijer Distribution Inc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Safeway

Allergy Relief | Safeway

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Meijer Distribution Inc

Allergy Relief | Meijer Distribution Inc

adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Publix Supermarkets, Inc.

Allergy Relief | Publix Supermarkets, Inc.

adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Meijer

Allergy Relief | Homeopet, Llc

Dose remedy directly into mouth, in water or on food A full dose may be given every 15 minutes up to 4 doses if needed, before or during fireworks For pets home alone, put 2 doses in water bowl, as they drink they will continue to be treated Dosing may be repeated as recommended above throughout the day if multiple stressful situations occur Remedy only needs to be used if pet is anxious

weight (lb)

drops per dose

animals less than 1 lb

2 in at least 8 oz of water

1-20

5

21-60

10

61-100

15

over 100

20

No Recall
Wal-mart Stores Inc

Allergy Relief | Wal-mart Stores Inc

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12
years and over 1 to 2 tablets
children 6 to under 12
years 1 tablet

children under 6 years do not use

No Recall
Allegiant Health

Allergy Relief | Allegiant Health

Adults and children 6 years and older One 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms
Adults 65 years and over Ask a doctor

Children under 6 years of age Ask a doctor

Consumers with liver or kidney Ask a doctor
disease

No Recall
Allegiant Health

Allergy Relief | Allegiant Health

Adults and children 6 years and over: 1 tablet daily: not more than 1 tablet in 24 hours
Children under 6 years of age: ask a doctor
Consumers with liver or kidney disease: ask a doctor

No Recall
Cvs Pharmacy

Allergy Relief | Cvs Pharmacy

• take every 4 to 6 hours, not more than 6 doses in 24 hours
adults & children 12 years of age and over

1 or 2 caplets

children 6 to under 12 years of age

1 caplet

children under 6 years of age

do not use

No Recall
Meijer, Inc.

Allergy Relief | Meijer, Inc.

take every 4 to 6 hours do not take more than 6 times in 24 hours adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use

No Recall
Chain Drug Marketing Association

Allergy Relief | Chain Drug Marketing Association

take every 4 to 6 hours do not exceed 6 doses in 24 hours * 12.5 mg dosage strength is not available in this package. Do not attempt to break capsules. adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 capsules) children 6 to under 12 years of age 12.5 mg * to 25 mg (1 capsule) children under 6 years of age ask a doctor

No Recall
Target Corporation

Allergy Relief | Target Corporation

adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Novartis Consumer Health, Inc.

Allergy Relief | Novartis Consumer Health, Inc.

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Novartsi Consumer Health, Inc.

Allergy Relief | Novartsi Consumer Health, Inc.

adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Publix Super Markets Inc

Allergy Relief | Publix Super Markets Inc

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
H E B

Allergy Relief | H E B

adults and children 12 years of age and over take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

No Recall
Cvs Pharmacy

Allergy Relief | American Health Packaging

Edema
Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.
Adults:
The usual initial dose of FUROSEMIDE TABLET is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of FUROSEMIDE TABLET may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving FUROSEMIDE TABLET on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests).
Geriatric Patients:
In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
Pediatric Patients:
The usual initial dose of oral FUROSEMIDE TABLET in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.
Hypertension
Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.
Adults:
The usual initial dose of FUROSEMIDE TABLET for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when furosemide tablets are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when FUROSEMIDE TABLET are added to the regimen. As the blood pressure falls under the potentiating effect of FUROSEMIDE TABLET, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.
Geriatric Patients:
In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
Edema
Therapy should be individualized according to patient response to gain maximal therapeutic response and to determine the minimal dose needed to maintain that response.
Adults:
The usual initial dose of FUROSEMIDE TABLET is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of FUROSEMIDE TABLET may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving FUROSEMIDE TABLET on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests).
Geriatric Patients:
In general, dose selection for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
Pediatric Patients:
The usual initial dose of oral FUROSEMIDE TABLET in pediatric patients is 2 mg/kg body weight, given as a single dose. If the diuretic response is not satisfactory after the initial dose, dosage may be increased by 1 or 2 mg/kg no sooner than 6 to 8 hours after the previous dose. Doses greater than 6 mg/kg body weight are not recommended. For maintenance therapy in pediatric patients, the dose should be adjusted to the minimum effective level.
Adults:
The usual initial dose of FUROSEMIDE TABLET is 20 to 80 mg given as a single dose. Ordinarily a prompt diuresis ensues. If needed, the same dose can be administered 6 to 8 hours later or the dose may be increased. The dose may be raised by 20 or 40 mg and given not sooner than 6 to 8 hours after the previous dose until the desired diuretic effect has been obtained. The individually determined single dose should then be given once or twice daily (e.g., at 8 am and 2 pm). The dose of FUROSEMIDE TABLET may be carefully titrated up to 600 mg/day in patients with clinically severe edematous states.

Edema may be most efficiently and safely mobilized by giving FUROSEMIDE TABLET on 2 to 4 consecutive days each week.

When doses exceeding 80 mg/day are given for prolonged periods, careful clinical observation and laboratory monitoring are particularly advisable (see PRECAUTIONS: Laboratory Tests).
Hypertension
Therapy should be individualized according to the patient's response to gain maximal therapeutic response and to determine the minimal dose needed to maintain the therapeutic response.
Adults:
The usual initial dose of FUROSEMIDE TABLET for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when furosemide tablets are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when FUROSEMIDE TABLET are added to the regimen. As the blood pressure falls under the potentiating effect of FUROSEMIDE TABLET, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.
Geriatric Patients:
In general, dose selection and dose adjustment for the elderly patient should be cautious, usually starting at the low end of the dosing range (see PRECAUTIONS: Geriatric Use).
Adults:
The usual initial dose of FUROSEMIDE TABLET for hypertension is 80 mg, usually divided into 40 mg twice a day. Dosage should then be adjusted according to response. If response is not satisfactory, add other antihypertensive agents.

Changes in blood pressure must be carefully monitored when furosemide tablets are used with other antihypertensive drugs, especially during initial therapy. To prevent excessive drop in blood pressure, the dosage of other agents should be reduced by at least 50 percent when FUROSEMIDE TABLET are added to the regimen. As the blood pressure falls under the potentiating effect of FUROSEMIDE TABLET, a further reduction in dosage or even discontinuation of other antihypertensive drugs may be necessary.

No Recall
Aldi Inc.

Allergy Relief | Aldi Inc.

take every 4 to 6 hours
do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

No Recall
Gmp Laboratories Of America, Inc

Allergy Relief | Gmp Laboratories Of America, Inc

do not use if printed blister foil backing is torn or missing adults and children over the age of 12, chew one tablet and allow to dissolve in the mouth every 4 hours children ages 2-12 years take one half the adult dosage not recommended for children under 2 years

No Recall
Cvs Pharmacy

Allergy Relief | Cvs Pharmacy

adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Cvs Pharmacy

Allergy Relief | Cvs Pharmacy

adults and children 12 years of age and over: take 1 tablet every 12 hours; not more than 2 tablets in 24 hours unless directed by a doctor children under 12 years of age: consult a doctor

No Recall
Cardinal Health

Allergy Relief | Cardinal Health

place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Homeocare Laboratories

Allergy Relief | Homeocare Laboratories

Turn tube upside down, twist cap to break seal & release pellets. Using clear cap, place 3 pellets to dissolve under your tongue 3 times a day or as needed.

No Recall
Mckesson (Sunmark)

Allergy Relief | Mckesson (sunmark)

take every 4 to 6 hours, not more than 6 doses in 24 hours adults and children 12 years of age and over take 1 or 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age consult a doctor children under 4 years of age do not use

No Recall
Publix Super Markets Inc

Allergy Relief | Publix Super Markets Inc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Army And Air Force Exchange Service

Allergy Relief | Fred's, Inc.

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

No Recall
Cvs Pharmacy

Allergy Relief | Par Pharmaceutical, Inc.

Argatroban Injection must be diluted 100-fold prior to infusion. Argatroban Injection should not be mixed with other drugs prior to dilution.
2.1 Preparation for Intravenous Administration
Argatroban Injection should be diluted in 0.9% Sodium Chloride Injection, 5% Dextrose Injection, or Lactated Ringer's Injection to a final concentration of 1 mg/mL. The contents of each 2.5-mL vial should be diluted 100-fold by mixing with 250 mL of diluent. Use 250 mg (2.5 mL) per 250 mL of diluent or 500 mg (5 mL) per 500 mL of diluent.

The constituted solution must be mixed by repeated inversion of the diluent bag for 1 minute. Upon preparation, the solution may show slight but brief haziness due to the formation of microprecipitates that rapidly dissolve upon mixing. Use of diluent at room temperature is recommended. The final solution must be clear before use. The pH of the intravenous solution prepared as recommended is 3.2 to 7.5.

Solutions prepared as recommended are stable at controlled room temperature, 20° to 25°C (68° to 77°F) (see USP) in ambient indoor light for 24 hours; therefore, light-resistant measures such as foil protection for intravenous lines are unnecessary. Solutions are physically and chemically stable for up to 96 hours when protected from light and stored at controlled room temperature, 20° to 25°C (68° to 77°F) (see USP), or at refrigerated conditions, 5°± 3°C (41°± 5°F). Prepared solutions should not be exposed to direct sunlight. No significant potency losses have been noted following simulated delivery of the solution through intravenous tubing.

Parenteral drug products should be inspected visually for particulate matter and discoloration prior to administration whenever solution and container permit.
2.2 Dosing in Patients with Heparin-Induced Thrombocytopenia
Initial Dosage: Before administering argatroban, discontinue heparin therapy and obtain a baseline aPTT. The recommended initial dose of argatroban for adult patients without hepatic impairment is 2 mcg/kg/min, administered as a continuous infusion (see Table 1).
Table 1. Recommended Doses and Infusion Rates for 2 mcg/kg/min Dose of Argatroban for Patients With HIT* and Without Hepatic Impairment (1 mg/mL Final Concentration) Body Weight (kg) Dose (mcg/min) Infusion Rate (mL/hr) * with or without thrombosis
50

100

6

60

120

7

70

140

8

80

160

10

90

180

11

100

200

12

110

220

13

120

240

14

130

260

16

140

280

17

Monitoring Therapy:

For use in HIT, therapy with Argatroban Injection is monitored using the aPTT with a target range of 1.5 to 3 times the initial baseline value (not to exceed 100 seconds). Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within 1 to 3 hours following initiation of Argatroban Injection. Check the aPTT 2 hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.

Dosage Adjustment:

After the initiation of Argatroban Injection, adjust the dose (not to exceed 10 mcg/kg/min) as necessary to obtain a steady-state aPTT in the target range [see Clinical Studies (14.1)].
2.3 Dosing in Patients Undergoing Percutaneous Coronary Intervention
Initial Dosage:

Initiate an infusion of Argatroban Injection at 25 mcg/kg/min and administer a bolus of 350 mcg/kg via a large bore intravenous line over 3 to 5 minutes (see Table 2). Check an activated clotting time (ACT) 5 to 10 minutes after the bolus dose is completed. The PCI procedure may proceed if the ACT is greater than 300 seconds.

Dosage Adjustment:

If the ACT is less than 300 seconds, an additional intravenous bolus dose of 150 mcg/kg should be administered, the infusion dose increased to 30 mcg/kg/min, and the ACT checked 5 to 10 minutes later (see Table 2). If the ACT is greater than 450 seconds, decrease the infusion rate to 15 mcg/kg/min, and check the ACT 5 to 10 minutes later (Table 3). Continue titrating the dose until a therapeutic ACT (between 300 and 450 seconds) has been achieved; continue the same infusion rate for the duration of the PCI procedure.

In case of dissection, impending abrupt closure, thrombus formation during the procedure, or inability to achieve or maintain an ACT over 300 seconds, additional bolus doses of 150 mcg/kg may be administered and the infusion dose increased to 40 mcg/kg/min. Check the ACT after each additional bolus or change in the rate of infusion.
Table 2. Recommended Starting and Maintenance Doses (Within the Target ACT Range) of Argatroban Injection in Patients Undergoing PCI Without Hepatic Impairment (1 mg/mL Final Concentration) Body Weight
(kg) Starting Bolus Dose
(350 mcg/kg) Starting and Maintenance Continuous Infusion Dosing For ACT
300-450 seconds
25 mcg/kg/min Bolus Dose
(mcg) Bolus Volume
(mL) Continuous Infusion Dose
(mcg/min) Continuous Infusion Rate
(mL/hr) NOTE: 1 mg = 1000 mcg; 1 kg = 2.2 lbs
50

17500

18

1250

75

60

21000

21

1500

90

70

24500

25

1750

105

80

28000

28

2000

120

90

31500

32

2250

135

100

35000

35

2500

150

110

38500

39

2750

165

120

42000

42

3000

180

130

45500

46

3250

195

140

49000

49

3500

210
Table 3. Recommended Dose Adjustments of Argatroban Injection for Patients Outside of ACT Target Range Undergoing PCI Without Hepatic Impairment (1 mg/mL Final Concentration) If ACT Less than 300 seconds
Dosage Adjustment*
30 mcg/kg/min If ACT Greater than 450 seconds
Dosage Adjustment†
15 mcg/kg/min Body Weight
(kg) Additional Bolus Dose
(mcg) Bolus Volume
(mL) Continuous Infusion Dose
(mcg/min) Continuous Infusion Rate
(mL/hr) Continuous Infusion Dose
(mcg/min) Continuous Infusion Rate
(mL/hr) NOTE: 1 mg = 1000 mcg; 1 kg = 2.2 lbs * Additional intravenous bolus dose of 150 mcg/kg should be administered if ACT less than 300 seconds † No bolus dose is given if ACT greater than 450 seconds
50

7500

8

1500

90

750

45

60

9000

9

1800

108

900

54

70

10500

11

2100

126

1050

63

80

12000

12

2400

144

1200

72

90

13500

14

2700

162

1350

81

100

15000

15

3000

180

1500

90

110

16500

17

3300

198

1650

99

120

18000

18

3600

216

1800

108

130

19500

20

3900

234

1950

117

140

21000

21

4200

252

2100

126

Monitoring Therapy:

For use in PCI, therapy with Argatroban Injection is monitored using ACT. Obtain ACTs before dosing, 5 to 10 minutes after bolus dosing, following adjustments in the infusion rate, and at the end of the PCI procedure. Obtain additional ACTs every 20 to 30 minutes during a prolonged procedure.

Continued Anticoagulation after PCI:

If a patient requires anticoagulation after the procedure, Argatroban Injection may be continued, but at a rate of 2 mcg/kg/min and adjusted as needed to maintain the aPTT in the desired range [see Dosage and Administration (2.1)].
2.4 Dosing in Patients With Hepatic Impairment
Initial Dosage:

For adult patients with HIT and moderate or severe hepatic impairment (based on Child-Pugh classification), an initial dose of 0.5 mcg/kg/min is recommended, based on the approximately 4-fold decrease in argatroban clearance relative to those with normal hepatic function. Monitor the aPTT closely, and adjust the dosage as clinically indicated.

Monitoring Therapy:

Achievement of steady state aPTT levels may take longer and require more dose adjustments in patients with hepatic impairment compared to patients with normal hepatic function.

For patients with hepatic impairment undergoing PCI and who have HIT or are at risk for HIT, carefully titrate argatroban until the desired level of anticoagulation is achieved. Use of Argatroban in PCI patients with clinically significant hepatic disease or AST/ALT levels ≥3 times the upper limit of normal should be avoided [see Warnings and Precautions (5.2)].
2.5 Dosing in Pediatric Patients With Heparin-Induced Thrombocytopenia/ Heparin-Induced Thrombocytopenia and Thrombosis Syndrome
Initial Dosage:

Initial argatroban infusion doses are lower for seriously ill pediatric patients compared to adults with normal hepatic function [see Use in Specific Populations (8.4)].

Monitoring Therapy:

In general, therapy with argatroban is monitored using the aPTT. Tests of anticoagulant effects (including the aPTT) typically attain steady-state levels within one to three hours following initiation of argatroban in patients without hepatic impairment [see Warnings and Precautions (5.2)]. Dose adjustment may be required to attain the target aPTT. Check the aPTT two hours after initiation of therapy and after any dose change to confirm that the patient has attained the desired therapeutic range.

Dosage Adjustment: [see Use in Specific Populations (8.4)]
2.6 Conversion to Oral Anticoagulant Therapy
Initiating Oral Anticoagulant Therapy:

When converting patients from Argatroban to oral anticoagulant therapy, consider the potential for combined effects on INR with co-administration of Argatroban and warfarin. A loading dose of warfarin should not be used. Initiate therapy using the expected daily dose of warfarin. To avoid prothrombotic effects and to ensure continuous anticoagulation when initiating warfarin, it is suggested that Argatroban and warfarin therapy be overlapped. There are insufficient data available to recommend the duration of the overlap.

Co-Administration of Warfarin and Argatroban Injection at Doses Up to 2 mcg/kg/min:

Measure INR daily while Argatroban Injection and warfarin are co-administered. In general, with doses of Argatroban Injection up to 2 mcg/kg/min, Argatroban Injection can be discontinued when the INR is >4 on combined therapy. After Argatroban Injection is discontinued, repeat the INR measurement in 4 to 6 hours. If the repeat INR is below the desired therapeutic range, resume the infusion of Argatroban Injection and repeat the procedure daily until the desired therapeutic range on warfarin alone is reached.

Co-Administration of Warfarin and Argatroban Injection at Doses Greater than 2 mcg/kg/min:

For doses of Argatroban greater than 2 mcg/kg/min, the relationship of INR between warfarin alone to the INR on warfarin plus argatroban is less predictable. In this case, in order to predict the INR on warfarin alone, temporarily reduce the dose of Argatroban Injection to a dose of 2 mcg/kg/min. Repeat the INR on Argatroban Injection and warfarin 4 to 6 hours after reduction of the Argatroban Injection dose and follow the process outlined above for administering Argatroban Injection at doses up to 2 mcg/kg/min.

No Recall
Woonsocket Prescription Center,incorporated

Allergy Relief | Delta Brands, Inc

• for adults and children 2 years and over use on hands and face to clean and refresh, allow skin to air dry. For children under 2 years of age ask a doctor before use.

No Recall
Medicine Shoppe International Inc

Allergy Relief | Medicine Shoppe International Inc

adults and children 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor

No Recall
Kroger Company

Allergy Relief | Kroger Company

adults and children 6 years and over 2 teaspoonfuls daily; do not take more than 2 teaspoonfuls in 24 hours children 2 to under 6 years of age 1 teaspoonful daily; do not take more than 1 teaspoonful in 24 hours consumers with liver or kidney disease ask a doctor

No Recall
Supervalu (Equaline)

Allergy Relief | Supervalu (equaline)

take every 4 to 6 hours do not take more than 6 times in 24 hours adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use

No Recall
Homeostasis Laboratories, Inc.

Allergy Relief | Homeostasis Laboratories, Inc.

(adults and children 8 years of age and older)

Chew two tablets thoroughly, allowing each to dissolve in the mouth, then swallow. Repeat with one tablet every 4 hours as needed.

No Recall
Army And Air Force Exchange Service

Allergy Relief | Apotex Corp

2.1 Adult Hypertension
Dosage must be individualized. Blood pressure response is dose related over the range of 2 to 32 mg. The usual recommended starting dose of candesartan cilexetil tablets are 16 mg once daily when it is used as monotherapy in patients who are not volume depleted. Candesartan cilexetil tablets can be administered once or twice daily with total daily doses ranging from 8 mg to 32 mg. Larger doses do not appear to have a greater effect, and there is relatively little experience with such doses. Most of the antihypertensive effect is present within 2 weeks, and maximal blood pressure reduction is generally obtained within 4 to 6 weeks of treatment with candesartan cilexetil tablets.

Use in Hepatic Impairment: Initiate with 8 mg candesartan cilexetil tablets in patients with moderate hepatic insufficiency. Dosing recommendations cannot be provided for patients with severe hepatic insufficiency [see CLINICAL PHARMACOLOGY (12.3)].

Candesartan cilexetil tablets may be administered with or without food.

If blood pressure is not controlled by candesartan cilexetil tablets alone, a diuretic may be added. Candesartan cilexetil tablets may be administered with other antihypertensive agents.
2.2 Pediatric Hypertension 1 to < 17 Years of age
Candesartan cilexetil tablets may be administered once daily or divided into two equal doses. Adjust the dosage according to blood pressure response. For patients with possible depletion of intravascular volume (e.g., patients treated with diuretics, particularly those with impaired renal function), initiate candesartan cilexetil tablets under close medical supervision and consider administration of a lower dose [see WARNINGS AND PRECAUTIONS (5.3)].

Children 1 to < 6 years of age

The dose range is 0.05 to 0.4 mg/kg per day. The recommended starting dose is 0.20 mg/kg (oral suspension).

Children 6 to < 17 years of age

For those less than 50 kg, the dose range is 2 to 16 mg per day. The recommended starting dose is 4 to 8 mg.

For those greater than 50 kg, the dose range is 4 to 32 mg per day. The recommended starting dose is 8 to 16 mg.

Doses above 0.4 mg/kg (1 to < 6 year olds) or 32 mg (6 to < 17 year olds) have not been studied in pediatric patients [see CLINICAL STUDIES (14.1)].

An antihypertensive effect is usually present within 2 weeks, with full effect generally obtained within 4 weeks of treatment with candesartan cilexetil tablets.

Children < 1 year of age must not receive candesartan cilexetil tablets for hypertension.

All pediatric patients with a glomerular filtration rate less than 30 ml/min/1.73m2 should not receive candesartan cilexetil tablets since candesartan cilexetil has not been studied in this population [see SPECIAL POPULATIONS (8)].

For children who cannot swallow tablets, an oral suspension may be substituted as described below:

Preparation of Oral Suspension

Candesartan cilexetil oral suspension can be prepared in concentrations within the range of 0.1 to 2.0 mg/mL. Typically, a concentration of 1 mg/mL will be suitable for the prescribed dose. Any strength of candesartan cilexetil tablets can be used in the preparation of the suspension.

Follow the steps below for preparation of the suspension. The number of tablets and volume of vehicle specified below will yield 160 mL of a 1 mg/mL suspension.
Prepare the vehicle by adding equal volumes of *Ora-Plus® (80 mL) and *Ora-Sweet SF® (80 mL) or, alternatively, use *,†Ora-Blend SF® (160 mL). Add a small amount of vehicle to the required number of candesartan cilexetil tablets (five 32 mg tablets) and grind into a smooth paste using a mortar and pestle. Add the paste to a preparation vessel of suitable size. Rinse the mortar and pestle clean using the vehicle and add this to the vessel. Repeat, if necessary. Prepare the final volume by adding the remaining vehicle. Mix thoroughly. Dispense into suitably sized amber PET bottles. Label with an expiry date of 100 days and include the following instructions:
Store at room temperature (below 30°C/86°F). Use within 30 days after first opening. Do not use after the expiry date stated on the bottle.

Do not freeze.

Shake well before each use.

*Ora-Plus®, Ora-Sweet SF®, and Ora-Blend SF® are registered trademarks of Paddock Laboratories, Inc.

†Supplied as a 50/50% pre-mix of Ora-Plus® and Ora-Sweet SF®.
2.3 Adult Heart Failure
The recommended initial dose for treating heart failure is 4 mg once daily. The target dose is 32 mg once daily, which is achieved by doubling the dose at approximately 2-week intervals, as tolerated by the patient.

No Recall
H E B

Allergy Relief | H E B

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Meijer Distribution Inc

Allergy Relief | Meijer Distribution Inc

• do not take more than directed (see Liver warning)

No Recall
Navarro Discount Pharmacies,llc

Allergy Relief | Navarro Discount Pharmacies,llc

take every 4 to 6 hours do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets) children 6 to under 12 years of age 25 mg (1 tablet)
children under 6 years of age

children under 4 years of age

ask a doctor

do not use

No Recall
P And L Development Of New York Corporation

Allergy Relief | P And L Development Of New York Corporation

adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

No Recall
Kareway Product, Inc.

Allergy Relief | Kareway Product, Inc.

take every 4 to 6 hours do not take more than 6 doses in 24 hours
adults and children 12 years of age and over 25 mg to 50 mg (1 to 2 tablets) children 6 to under 12 years of age 12.5** to 25 mg (1 tablet) children under 6 years of age ask a doctor
**12.5 mg dosage strength is not available in this package. Do not attempt to break tablets.

No Recall
Kareway Product, Inc.

Allergy Relief | Kareway Product, Inc.

Adults and children 12 years and over: Take one (1) tablet every 4 to 6 hours. Do not exceed 6 tablets in 24 hours. Children 12 years and under: Consult a physician before use

No Recall
Dolgencorp, Llc

Allergy Relief | Dolgencorp, Llc

take every 4 to 6 hours

do not take more than 6 doses in 24 hours

adults and children 12 years of age and over
1 to 2 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 years of age

No Recall
Top Care (Topco Associates Llc)

Allergy Relief | Top Care (topco Associates Llc)

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over take 1 to 2 tablets children 6 to under 12 years of age take 1 tablet children under 6 years of age do not use this product in children under 6

No Recall
L.n.k. International, Inc.

Allergy Relief | L.n.k. International, Inc.

take every 4 to 6 hours, or as directed by a doctor

do not take more than 6 times in 24 hours

adults and children 12
years and over
1 to 2 tablets children 6 to under 12
years 1 tablet children under 6 years
do not use

No Recall
L.n.k. International, Inc.

Allergy Relief | L.n.k. International, Inc.

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12
year of age and over 1 to 2 capsules children 6 to under 12
years of age 1 capsule children under 6 years
of age do not use this
product in children
under 6 years of age

No Recall
Family Dollar

Allergy Relief | Family Dollar

do not exceed 6 doses in 24 hours adults and 12 years of age and older
1 tablet every 4 to 6 hours. Do not take more than 6 tablets in 24 hours
children 6 years to under 12 years of age
1/2 tablet (break tablet in half) every 4 to 6 hours. Do not exceend 3 whole tablets in 24 hours. children under 6 years of age
do not use this product in children under 6 years of age

No Recall
Family Dollar

Allergy Relief | Family Dollar

take every 4 to 6 hours

do not take more than 6 doses in 24 hours

adults and children 12 years of age and over
1 to 2 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use

No Recall
Geri-care Pharmaceutical Corp

Allergy Relief | Geri-care Pharmaceutical Corp

adults and children
12 years and over
1 tablet daily; not more
than 1 tablet in 24 hours
children under 12
years of age
ask a doctor
consumers with liver
or kidney disease
ask a doctor

No Recall
Army And Air Force Exchange Service

Allergy Relief | Target Corporation

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

No Recall
Rite Aid

Allergy Relief | Medsource Pharmaceuticals

Dosage should be adjusted according to the severity of the pain and the response of the patient. It may occasionally be necessary to exceed the usual dosage recommended below in cases of more severe pain or in those patients who have become tolerant to the analgesic effect of opioids. If pain is constant, the opioid analgesic should be given at regular intervals on an around-the-clock schedule. Oxycodone and Acetaminophen Tablets are given orally.

Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg

The usual adult dosage is one tablet every 6 hours as needed for pain. The total daily dose of acetaminophen should not exceed 4 grams.
Strength Maximal Daily Dose Oxycodone and Acetaminophen Tablets, USP, 10 mg/325 mg 6 Tablets Cessation of Therapy
In patients treated with Oxycodone and Acetaminophen Tablets for more than a few weeks who no longer require therapy, doses should be tapered gradually to prevent signs and symptoms of withdrawal in the physically dependent patient.

No Recall
Rite Aid

Allergy Relief | Rite Aid

take every 4 to 6 hours

do not take more than 6 doses in 24 hours

adults and children 12 years of age and over
1 to 2 tablets children 6 to under 12 years of age 1 tablet children under 6 years of age do not use this product in children under 6 years of age

No Recall
Family Dollar

Allergy Relief | Family Dollar

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12
years of age and over 1 to 2 capsules children 6 to under 12
years of age 1 capsule children under 6
years of age do not use this
product in children
under 6 years of age

No Recall
Kroger Company

Allergy Relief | Kroger Company

adults and children 12 years and over

1 tablet every 4 to 6 hours, not to exceed 6 tablets in 24 hours

children 6 to under 12 years of age

½ tablet (break tablet in half) every 4 to 6 hours, not to exceed 3 whole tablets in 24 hours

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

No Recall
Shopko Stores Operating Co., Llc

Allergy Relief | Shopko Stores Operating Co., Llc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Rite Aid

Allergy Relief | Rite Aid

take every 4 to 6 hours
do not take more than 6 doses in 24 hours adults and children 12 years of age and over 1 to 2 capsules children 6 to under 12 years of age 1 capsule children under 6 years of age do not use this product in children under 6 years of age

No Recall
Shopko Stores Operating Co., Llc

Allergy Relief | Shopko Stores Operating Co., Llc

• take every 4 to 6 hours, not more than 6 doses in 24 hours
adults and children 12 years of age and over

1 or 2 tablets

children 6 to under 12 years of age

1 tablet

children 4 to under 6 years of age

do not use unless directed by a doctor

children under 4 years of age

do not use

No Recall
Shopko Stores Operating Co., Llc

Allergy Relief | Oceanside Pharmaceuticals

For topical use only. Fluocinonide Cream is not for ophthalmic, oral, or intravaginal use.

For psoriasis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected skin areas as directed by a physician. Twice daily application for the treatment of psoriasis has been shown to be more effective in achieving treatment success during 2 weeks of treatment.

For atopic dermatitis, apply a thin layer of Fluocinonide Cream once daily to the affected skin areas as directed by a physician. Once daily application for the treatment of atopic dermatitis has been shown to be as effective as twice daily treatment in achieving treatment success during 2 weeks of treatment [see Clinical Studies (14)].

For corticosteroid responsive dermatoses, other than psoriasis or atopic dermatitis, apply a thin layer of Fluocinonide Cream once or twice daily to the affected areas as directed by a physician.

No Recall
Safeway

Allergy Relief | Tya Pharmaceuticals

Citalopram HBr should be administered once daily, in the morning or evening, with or without food.

Initial Treatment

Citalopram HBr should be administered at an initial dose of 20 mg once daily, with an increase to a maximum dose of 40 mg/day at an interval of no less than one week. Doses above 40 mg/day are not recommended due to the risk of QT prolongation. Additionally, the only study pertinent to dose response for effectiveness did not demonstrate an advantage for the 60 mg/day dose over the 40 mg/day dose.

Special Populations

20 mg/day is the maximum recommended dose for patients who are greater than 60 years of age, patients with hepatic impairment, and for CYP2C19 poor metabolizers or those patients taking cimetidine or another CYP2C19 inhibitor. (see ) WARNINGS

No dosage adjustment is necessary for patients with mild or moderate renal impairment. Citalopram tablets should be used with caution in patients with severe renal impairment.

Treatment of Pregnant Women During the Third Trimester

Neonates exposed to Citalopram tablets and other SSRIs or SNRIs, late in the third trimester, have developed complications requiring prolonged hospitalization, respiratory support, and tube feeding (see ). When treating pregnant women with Citalopram tablets during the third trimester, the physician should carefully consider the potential risks and benefits of treatment. PRECAUTIONS

Maintenance Treatment

It is generally agreed that acute episodes of depression require several months or longer of sustained pharmacologic therapy. Systematic evaluation of Citalopram tablets in two studies has shown that its antidepressant efficacy is maintained for periods of up to 24 weeks following 6 or 8 weeks of initial treatment (32 weeks total). In one study, patients were assigned randomly to placebo or to the same dose of Citalopram tablets (20-60 mg/day) during maintenance treatment as they had received during the acute stabilization phase, while in the other study, patients were assigned randomly to continuation of Citalopram tablets 20 or 40 mg/day, or placebo, for maintenance treatment. In the latter study, the rates of relapse to depression were similar for the two dose groups (see under ). Based on these limited data, it is not known whether the dose of citalopram needed to maintain euthymia is identical to the dose needed to induce remission. If adverse reactions are bothersome, a decrease in dose to 20 mg/day can be considered. Clinical TrialsCLINICAL PHARMACOLOGY

Discontinuation of Treatment with Citalopram tablets

Symptoms associated with discontinuation of Citalopram tablets and other SSRIs and SNRIs have been reported (see ). Patients should be monitored for these symptoms when discontinuing treatment. A gradual reduction in the dose rather than abrupt cessation is recommended whenever possible. If intolerable symptoms occur following a decrease in the dose or upon discontinuation of treatment, then resuming the previously prescribed dose may be considered. Subsequently, the physician may continue decreasing the dose but at a more gradual rate. PRECAUTIONS

Switching a Patient To or From a Monoamine Oxidase Inhibitor (MAOI) Intended to Treat Psychiatric Disorders

At least 14 days should elapse between discontinuation of an MAOI intended to treat psychiatric disorders and initiation of therapy with Citalopram Hydrobromide tablet. Conversely, at least 14 days should be allowed after stopping Citalopram Hydrobromide tablet before starting an MAOI intended to treat psychiatric disorders (see ). CONTRAINDICATIONS

Use of Citalopram Hydrobromide tablet with Other MAOIs, Such as Linezolid or Methylene Blue

Do not start Citalopram Hydrobromide tablet in a patient who is being treated with linezolid or intravenous methylene blue because there is an increased risk of serotonin syndrome. In a patient who requires more urgent treatment of a psychiatric condition, other interventions, including hospitalization, should be considered (see ). CONTRAINDICATIONS

In some cases, a patient already receiving Citalopram Hydrobromide tablet therapy may require urgent treatment with linezolid or intravenous methylene blue. If acceptable alternatives to linezolid or intravenous methylene blue treatment are not available and the potential benefits of linezolid or intravenous methylene blue treatment are judged to outweigh the risks of serotonin syndrome in a particular patient, Citalopram Hydrobromide tablet should be stopped promptly, and linezolid or intravenous methylene blue can be administered. The patient should be monitored for symptoms of serotonin syndrome for 2 weeks or until 24 hours after the last dose of linezolid or intravenous methylene blue, whichever comes first. Therapy with Citalopram Hydrobromide tablet may be resumed 24 hours after the last dose of linezolid or intravenous methylene blue (see ). WARNINGS

The risk of administering methylene blue by non-intravenous routes (such as oral tablets or by local injection) or in intravenous doses much lower than 1 mg/kg with Citalopram Hydrobromide tablet is unclear. The clinician should, nevertheless, be aware of the possibility of emergent symptoms of serotonin syndrome with such use (see ). WARNINGS

No Recall
Homeolab Usa Inc.

Allergy Relief | Homeolab Usa Inc.

Adults: Allow 3 to 4 pellets to dissolve in mouth at onset of symptoms of allergies. Repeat every 15 minutes until relief begins, then take three times a day.

Children under 12: Take 1/2 the adult dose.

No Recall
Rite Aid Corporation

Allergy Relief | Rite Aid Corporation

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Homeolab Usa Inc.

Allergy Relief | Homeolab Usa Inc.

Adults: 15-20 drops under the tongue or in a teaspoonful of water 3 times a day. Children under 12: Take 1/2 the adult dose.

No Recall
Preferred Plus (Kinray)

Allergy Relief | Preferred Plus (kinray)

take every 4 to 6 hours do not take more than 6 doses in 24 hours swallow whole; do not crush, chew, or dissolve adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use

No Recall
Rite Aid Corporation

Allergy Relief | Rite Aid Corporation

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
L.n.k. International, Inc.

Allergy Relief | Publix Super Markets Inc

• take only as directed – see Overdose warning • use dose cup • do not exceed 4 doses per 24 hrs
adults & children 12 yrs & over

30 mL (2 TBSP) every 6 hrs

children 4 to under 12 yrs

ask a doctor

children under 4 yrs

do not use

No Recall
A&z Pharmaceutical, Inc.

Allergy Relief | A&z Pharmaceutical, Inc.

Adults and children 6 years and older One 10mg tablet once daily; do not take more than one 10mg tablet in 24 hours. A 5mg product may be appropriate for less severe symptoms
Adults 65 years and over Ask a doctor

Children under 6 years of age Ask a doctor

Consumers with liver or kidney Ask a doctor
disease

No Recall
A&z Pharmaceutical, Inc

Allergy Relief | The University Of Utah Dba Cyclotron Radiochemistry Lab Huntsman Cancer Institute

2.1 Radiation Safety - Drug Handling Wear waterproof gloves and effective shielding when handling Sodium Fluoride F 18 Injection. Use appropriate safety measures, including shielding, consistent with proper patient management to avoid unnecessary radiation exposure to the patient, occupational workers, clinical personnel, and other persons.
Radiopharmaceuticals should be used by or under the control of physicians who are qualified by specific training and experience in the safe use and handling of radionuclides, and whose experience and training have been approved by the appropriate governmental agency authorized to license the use of radionuclides.
Use aseptic technique to maintain sterility during all operations involved in the manipulation and administration of Sodium Fluoride F 18 Injection.
The dose of Sodium Fluoride F 18 Injection should be minimized consistent with the objectives of the procedure, and the nature of the radiation detection devices employed.
The final dose for the patient should be calculated using proper decay factors from the time of End of Synthesis (EOS), and measured by a suitable radioactivity calibration system before administration [see Description (11.2)]. 2.2 Radiation Safety - Patient Preparation To minimize the radiation-absorbed dose to the bladder, encourage adequate hydration. Encourage the patient to ingest at least 500 mL of fluid immediately prior and subsequent to the administration of Sodium Fluoride F 18 Injection.
Encourage the patient to void one-half hour after administration of Sodium Fluoride F 18 Injection and as frequently thereafter as possible for the next 12 hours. 2.3 Drug Preparation and Administration Calculate the necessary volume to administer based on calibration time and dose.
Inspect Sodium Fluoride F 18 Injection visually for particulate matter and discoloration before administration, whenever solution and container permit.
Do not administer Sodium Fluoride F 18 Injection containing particulate matter or discoloration; dispose of these unacceptable or unused preparations in a safe manner, in compliance with applicable regulations.
Aseptically withdraw Sodium Fluoride F 18 Injection from its container. 2.4 Recommended Dose for Adults
Administer 300–450 MBq (8–12 mCi) as an intravenous injection.
2.5 Recommended Dose for Pediatric Patients
In reported clinical experience in approximately 100 children, weight based doses (2.1 MBq/kg) ranging from 19 MBq–148 MBq (0.5 mCi–4 mCi) were used.
2.6 Radiation Dosimetry
The age/weight- based estimated absorbed radiation doses (mGy/MBq) from intravenous injection of Sodium Fluoride F 18 Injection are shown in Table 1. These estimates were calculated based on human data and using the data published by the Nuclear Regulatory Commission [1] and the International Commission on Radiological Protection for Sodium Fluoride Injection [2]. The bone, bone marrow and urinary bladder are considered target and critical organs.
Table 1: Estimated Absorbed Radiation Doses after Intravenous Administration of Sodium Fluoride F 18 Injection Organ Estimated Radiation Dose mGy/MBq Adult
70 kg [1] 15 year
56.8 kg [2] 10 year
33.2 kg [2] 5 year
19.8 kg [2] 1 year
9.7 kg [2] Adrenals 0.0062 0.012 0.018 0.028 0.052 Brain 0.0056 N/A N/A N/A N/A Bone
surfaces 0.060 0.050 0.079 0.13 0.30 Breasts 0.0028 0.0061 0.0097 0.015 0.030 GI Gallbladder wall 0.0044 N/A N/A N/A N/A Stomach wall 0.0038 0.008 0.013 0.019 0.036 Small intestine 0.0066 0.012 0.018 0.028 0.052 Upper large intestine wall 0.0058 0.010 0.016 0.026 0.046 Lower large intestine wall 0.012 0.016 0.025 0.037 0.063 Heart wall 0.0039 N/A N/A N/A N/A Kidneys 0.019 0.025 0.036 0.053 0.097 Liver 0.0040 0.0084 0.013 0.021 0.039 Lungs 0.0041 0.0084 0.013 0.020 0.039 Muscle 0.0060 N/A N/A N/A N/A Ovaries 0.011 0.016 0.023 0.036 0.063 Pancreas 0.0048 0.0096 0.015 0.023 0.044 Red marrow 0.028 0.053 0.088 0.18 0.38 Skin 0.0040 N/A N/A N/A N/A Spleen 0.0042 0.0088 0.014 0.021 0.041 Testes 0.0078 0.013 0.021 0.033 0.062 Thymus 0.0035 N/A N/A N/A N/A Thyroid 0.0044 0.0084 0.013 0.020 0.036 Urinary bladder wall 0.25 0.27 0.4 0.61 1.1 Uterus 0.019 0.023 0.037 0.057 0.099 Other tissue N/A 0.010 0.015 0.024 0.044 Effective Dose Equivalent mSv/MBq 0.027 0.034 0.052 0.086 0.17
[1] Data from Nuclear Regulatory Commission Report, Radiation Dose Estimates for Radiopharmaceuticals, NUREG/CR-6345, page 10, 1996.

[2] Data from ICRP publication 53, Radiation Dose to Patients from Radiopharmaceuticals , Ann ICRP, Volume 18, pages 15 and 74, 1987
2.7 Imaging Guidelines Imaging of Sodium Fluoride F 18 Injection can begin 1–2 hours after administration; optimally at 1 hour post administration.
Encourage the patient to void immediately prior to imaging the fluoride F18 radioactivity in the lumbar spine or bony pelvis.

No Recall
Kroger Company

Allergy Relief | Kroger Company

adults and children 12 years of age and over

take one 60 mg tablet with water every 12 hours; do not take more than 2 tablets in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Healthy Accents (Dza Brands, Llc)

Allergy Relief | Healthy Accents (dza Brands, Llc)

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over take 1 to 2 tablets children 6 to under 12 years of age take 1 tablet children under 6 years of age do not use this product in children under 6

No Recall
Western Family Foods, Inc.

Allergy Relief | Western Family Foods, Inc.

adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Wal-mart Stores, Inc.

Allergy Relief | Wal-mart Stores, Inc.

180 mg
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

No Recall
Safeway Inc

Allergy Relief | Safeway Inc

180 mg
adults and children 12 years of age and over take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours children under 12 years of age do not use Adults 65 years of age and older ask a doctor consumers with kidney disease ask a doctor

No Recall
Meijer Distribution Inc

Allergy Relief | Ag Professional Hair Care Products, Ltd

USE TWICE A WEEK, OR AS DIRECTED BY A PHYSICIAN FOR CHRONIC CONDITIONS. MASSAGE INTO SCALP FOR 3-5 MINUTES. RINSE THOROUGHLY.

No Recall
Hyvee Inc

Allergy Relief | Hyvee Inc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Rite Aid Corporation

Allergy Relief | Pd-rx Pharmaceuticals, Inc.

Cefadroxil capsules are acid-stable and may be administered orally without regard to meals. Administration with food may be helpful in diminishing potential gastrointestinal complaints occasionally associated with oral cephalosporin therapy.
Adults Urinary Tract Infections
For uncomplicated lower urinary tract infections (i.e., cystitis) the usual dosage is 1 or 2 g per day in a single (q.d.) or divided doses (b.i.d.).

For all other urinary tract infections the usual dosage is 2 g per day in divided doses (b.i.d.).
Skin and Skin Structure Infections
For skin and skin structure infections the usual dosage is 1 g per day in single (q.d.) or divided doses (b.i.d.).
Pharyngitis and Tonsillitis
Treatment of group A beta-hemolytic streptococcal pharyngitis and tonsillitis – 1 g per day in single (q.d.) or divided doses (b.i.d.) for 10 days.
Children
For urinary tract infections, the recommended daily dosage for children is 30 mg/kg/day in divided doses every 12 hours. For pharyngitis, tonsillitis, and impetigo, the recommended daily dosage for children is 30 mg/kg/day in a single dose or in equally divided doses every 12 hours. For other skin and skin structure infections, the recommended daily dosage is 30 mg/kg/day in equally divided doses every 12 hours. In the treatment of beta-hemolytic streptococcal infections, a therapeutic dosage of cefadroxil capsules should be administered for at least 10 days.

See chart for total daily dosage for children.
DAILY DOSAGE OF CEFADROXIL FOR ORAL SUSPENSION Child’s Weight lbs kg 250 mg/5 mL 500 mg/5 mL 10 4.5 ½ tsp 20 9.1 1 tsp 30 13.6 1½ tsp 40 18.2 2 tsp 1 tsp 50 22.7 2½ tsp 1¼ tsp 60 27.3 3 tsp 1½ tsp 70 & above 31.8 + -- 2 tsp Renal Impairment
In patients with renal impairment, the dosage of cefadroxil monohydrate should be adjusted according to creatinine clearance rates to prevent drug accumulation. The following schedule is suggested. In adults, the initial dose is 1000 mg of cefadroxil capsules and the maintenance dose (based on the creatinine clearance rate [mL/min/1.73 m2]) is 500 mg at the time intervals listed below.
Creatinine Clearances Dosage Interval 0 to 10 mL/min 36 hours 10 to 25 mL/min 24 hours 25 to 50 mL/min 12 hours
Patients with creatinine clearance rates over 50 mL/min may be treated as if they were patients having normal renal function.

No Recall
Western Family Foods Inc

Allergy Relief | Western Family Foods Inc

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Geri-care Pharmaceutical Corp

Allergy Relief | Geri-care Pharmaceutical Corp

do not exceed recommended dose adults and children 12 years and over: take 1 tablet every 4 to 6
hours, as needed, not more than 6 tablets in 24 hours or as directed by a doctor
children under 12 years: consult a doctor

No Recall
Shopko Stores Operating Co., Llc

Allergy Relief | Shopko Stores Operating Co., Llc

adults and children 6 years and over

one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms.

adults 65 years and over

ask a doctor

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Kroger Company

Allergy Relief | Kroger Company

adults and children 6 years and over

1 tablet daily; not more than 1 tablet in 24 hours

children under 6 years of age

ask a doctor

consumers with liver or kidney disease

ask a doctor

No Recall
Ohm Laboratories Inc.

Allergy Relief | Ohm Laboratories Inc.

place 1 tablet on tongue; tablet disintegrates, with or without water adults and children 6 years and over 1 tablet daily; not more than 1 tablet in 24 hours children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Wal-mart Stores Inc

Allergy Relief | Wal-mart Stores Inc

adults and children 6 years and over one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A 5 mg product may be appropriate for less severe symptoms. adults 65 years and over ask a doctor children under 6 years of age ask a doctor consumers with liver or kidney disease ask a doctor

No Recall
Kroger Company

Allergy Relief | Cardinal Health

DISTRIBUTED BY:

CARDINAL HEALTH

DUBLIN, OHIO 43017 USA

No Recall
Bio-pharm, Inc.

Allergy Relief | Bio-pharm, Inc.

use only enclosed dosing cup to dose this product do not take more than 6 doses in 24 hours take every 4 to 6 hours adults and children 12 years of age and over 2-4 TSP (10mL - 20mL) adults and children 6 to under 12 years of age 1-2 TSP (5mL - 10mL) children 2 to 5 years of age ask a doctor children under 2 years of age do not use

No Recall
Kroger Company

Allergy Relief | Kroger Company

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Hyvee Inc

Allergy Relief | Target Corporation

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Safeway

Allergy Relief | Teva Pharmaceuticals Usa Inc

BECAUSE OF THE UNIQUE PHARMACOKINETIC PROPERTIES, DIFFICULT DOSING SCHEDULE, AND SEVERITY OF THE SIDE EFFECTS IF PATIENTS ARE IMPROPERLY MONITORED, AMIODARONE HYDROCHLORIDE TABLETS SHOULD BE ADMINISTERED ONLY BY PHYSICIANS WHO ARE EXPERIENCED IN THE TREATMENT OF LIFE-THREATENING ARRHYTHMIAS WHO ARE THOROUGHLY FAMILIAR WITH THE RISKS AND BENEFITS OF AMIODARONE THERAPY, AND WHO HAVE ACCESS TO LABORATORY FACILITIES CAPABLE OF ADEQUATELY MONITORING THE EFFECTIVENESS AND SIDE EFFECTS OF TREATMENT.

In order to insure that an antiarrhythmic effect will be observed without waiting several months, loading doses are required. A uniform, optimal dosage schedule for administration of amiodarone hydrochloride tablets has not been determined. Because of the food effect on absorption, amiodarone hydrochloride tablets should be administered consistently with regard to meals (see CLINICAL PHARMACOLOGY). Individual patient titration is suggested according to the following guidelines:

For life-threatening ventricular arrhythmias, such as ventricular fibrillation or hemodynamically unstable ventricular tachycardia:Close monitoring of the patients is indicated during the loading phase, particularly until risk of recurrent ventricular tachycardia or fibrillation has abated. Because of the serious nature of the arrhythmia and the lack of predictable time course of effect, loading should be performed in a hospital setting. Loading doses of 800 to 1,600 mg/day are required for 1 to 3 weeks (occasionally longer) until initial therapeutic response occurs. (Administration of amiodarone hydrochloride tablets in divided doses with meals is suggested for total daily doses of 1,000 mg or higher, or when gastrointestinal intolerance occurs.) If side effects become excessive, the dose should be reduced. Elimination of recurrence of ventricular fibrillation and tachycardia usually occurs within 1 to 3 weeks, along with reduction in complex and total ventricular ectopic beats.

Since grapefruit juice is known to inhibit CYP3A4-mediated metabolism of oral amiodarone in the intestinal mucosa, resulting in increased plasma levels of amiodarone, grapefruit juice should not be taken during treatment with oral amiodarone (see PRECAUTIONS, Drug Interactions).

Upon starting amiodarone hydrochloride tablet therapy, an attempt should be made to gradually discontinue prior antiarrhythmic drugs (see PRECAUTIONS, Drug Interactions). When adequate arrhythmia control is achieved, or if side effects become prominent, amiodarone hydrochloride tablet dose should be reduced to 600 to 800 mg/day for one month and then to the maintenance dose, usually 400 mg/day (see CLINICAL PHARMACOLOGY, Monitoring Effectiveness). Some patients may require larger maintenance doses, up to 600 mg/day, and some can be controlled on lower doses. Amiodarone hydrochloride tablets may be administered as a single daily dose, or in patients with severe gastrointestinal intolerance, as a b.i.d. dose. In each patient, the chronic maintenance dose should be determined according to antiarrhythmic effect as assessed by symptoms, Holter recordings, and/or programmed electrical stimulation and by patient tolerance. Plasma concentrations may be helpful in evaluating nonresponsiveness or unexpectedly severe toxicity (see CLINICAL PHARMACOLOGY).

The lowest effective dose should be used to prevent the occurrence of side effects. In all instances, the physician must be guided by the severity of the individual patient’s arrhythmia and response to therapy.

When dosage adjustments are necessary, the patient should be closely monitored for an extended period of time because of the long and variable half-life of amiodarone and the difficulty in predicting the time required to attain a new steady-state level of drug. Dosage suggestions are summarized below:

Loading Dose

Adjustment and Maintenance Dose

(Daily)

(Daily)

Ventricular Arrhythmias

1 to 3 weeks

~1 month

usual maintenance

800 to 1,600 mg

600 to 800 mg

400 mg

No Recall
Meijer Distribution Inc

Allergy Relief | Meijer Distribution Inc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Supervalu Inc.

Allergy Relief | Supervalu Inc.

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12
years and over 1 to 2 tablets

children 6 to under 12
years 1 tablet

children under 6 years do not use

No Recall
Supervalu Inc.

Allergy Relief | Supervalu Inc.

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children
12 years of age and
over
1 to 2 capsules
children 6 to under
12 years of age
1 capsule
children under 6
years of age
do not use this
product in children
under 6 years of age

No Recall
Safeway

Allergy Relief | Better Living Brands, Llc

take every 4 to 6 hours, or as directed by a doctor do not take more than 6 times in 24 hours adults and children 12
years and over 1 to 2 tablets children 6 to under 12
years 1 tablet children under 6 years do not use

No Recall
Western Family Foods Inc

Allergy Relief | Western Family Foods Inc

adults and children 12 years of age and over

take one 180 mg tablet with water once a day; do not take more than 1 tablet in 24 hours

children under 12 years of age

do not use

adults 65 years of age and older

ask a doctor

consumers with kidney disease

ask a doctor

No Recall
Hyvee Inc

Allergy Relief | Hyvee Inc

• do not take more than directed (see overdose warning)
adults and children 12 years and over
• take 2 caplets every 4-6 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
Best Choice (Valu Merchandisers Company)

Allergy Relief | Best Choice (valu Merchandisers Company)

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use

No Recall
Mckesson (Sunmark)

Allergy Relief | Mckesson (sunmark)

take every 4 to 6 hours do not take more than 6 doses in 24 hours adults and children 12 years of age and over take 1 to 2 capsules children 6 to under 12 years of age take 1 capsule children under 6 years of age do not use

No Recall