FDA records indicate that there are no current recalls for this drug.
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Acetaminophen Extra Strength Recall
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Questions & Answers
Side Effects & Adverse Reactions
Liver warning: This product contains acetaminophen. The maximum daily dose of this product is 6 gelcaps (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
Allergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- skin reddening
- blisters
- rash
If a skin reaction occurs, stop use and seek medical help right away.
- if you are allergic to acetaminophen or any of the inactive ingredients in 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.
liver disease.
taking the blood thinning drug warfarin.
- pain gets worse or lasts more than 10 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition.
ask a health professional before use.
In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
- if you are allergic to acetaminophen or any of the inactive ingredients in 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.
liver disease.
Ask a doctor or pharmacist before use if you aretaking the blood thinning drug warfarin.
Stop use and ask a doctor if- pain gets worse or lasts more than 10 days
- new symptoms occur
- fever gets worse or lasts more than 3 days
- redness or swelling is present
These could be signs of a serious condition.
Legal Issues
There is currently no legal information available for this drug.
FDA Safety Alerts
There are currently no FDA safety alerts available for this drug.
Manufacturer Warnings
There is currently no manufacturer warning information available for this drug.
FDA Labeling Changes
There are currently no FDA labeling changes available for this drug.
Uses
- temporarily relieves minor aches and pains due to:
- backache
- toothache
- headache
- the common cold
- muscular aches
- minor pain of arthritis
- premenstrual and menstrual cramps
- temporarily reduces fever
History
There is currently no drug history available for this drug.
Other Information
There are no additional details available for this product.
Sources
Acetaminophen Extra Strength Manufacturers
- Sam’s West Inc
Acetaminophen Extra Strength | Sam's West Inc
do not take more than directed
adults and children 12 years and over take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps 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 - Supervalu Inc.
Acetaminophen Extra Strength | Supervalu 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 - Equate (Walmart Stores, Inc.)
Acetaminophen Extra Strength | Equate (walmart Stores, 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 do not take for more than 10 days unless directed by a doctor children under 12 years: do not use - Winco Foods, Llc
Acetaminophen Extra Strength | Winco Foods, 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 use for more than 10 days unless directed by a doctor children under 12 years ask a doctor - Family Dollar (Family Wellness)
- Amneal Pharmaceuticals
- New World Imports, Inc
Acetaminophen Extra Strength | Macleods Pharmaceuticals Limited
2.1 AsthmaMontelukast sodium chewable tabletsshould be taken once daily in the evening. The following doses are recommended:
For adults and adolescents 15 years of age and older: 10 mg.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet.
Safety and effectiveness in pediatric patients less than 12 months of age with asthma have not been established.
There have been no clinical trials in patients with asthma to evaluate the relative efficacy of morning versus evening dosing. The pharmacokinetics of montelukast are similar whether dosed in the morning or evening. Efficacy has been demonstrated for asthma when montelukast was administered in the evening without regard to time of food ingestion.
2.2 Exercise-Induced Bronchoconstriction (EIB)For prevention of EIB, a single dose of montelukast sodium should be taken at least 2 hours before exercise.
The following doses are recommended:
For adults and adolescents 15 years of age and older: 10 mg.
An additional dose of montelukast sodium should not be taken within 24 hours of a previous dose. Patients already taking montelukast sodium daily for another indication (including chronic asthma) should not take an additional dose to prevent EIB. All patients should have available for rescue a short-acting β-agonist. Safety and efficacy in patients younger than 15 years of age have not been established. Daily administration of montelukast sodium for the chronic treatment of asthma has not been established to prevent acute episodes of EIB.
Pediatric use information for patients ages 6 to 14 years of age for acute prevention of exercise-induced bronchoconstriction (EIB) is approved for Merck Sharp & Dohme Corp’s montelukast tablet products. However, due to Merck Sharp & Dohme Corp’s marketing exclusivity rights, this drug product is not labeled with that pediatric information.
2.3 Allergic RhinitisFor allergic rhinitis, montelukast sodium chewable tablets should be taken once daily. Efficacy was demonstrated for seasonal allergic rhinitis when montelukast was administered in the morning or the evening without regard to time of food ingestion. The time of administration may be individualized to suit patient needs.
The following doses for the treatment of symptoms of seasonal allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: 10 mg.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 2 years of age with seasonal allergic rhinitis have not been established.
The following doses for the treatment of symptoms of perennial allergic rhinitis are recommended:
For adults and adolescents 15 years of age and older: 10 mg.
For pediatric patients 6 to 14 years of age: one 5-mg chewable tablet.
For pediatric patients 2 to 5 years of age: one 4-mg chewable tablet.
Safety and effectiveness in pediatric patients younger than 6 months of age with perennial allergic rhinitis have not been established.
2.4 Asthma and Allergic RhinitisPatients with both asthma and allergic rhinitis should take only one montelukast sodium chewable tablet dose daily in the evening.
- New World Imports, Inc
Acetaminophen Extra Strength | New World Imports, Inc
Adults and children 12 years of age and older: Take 2 caplets every 4 to 6 hours as needed. Do not take more than 8 caplets in 24 hours.
Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
- Physicians Total Care, Inc.
- Physicians Total Care, Inc.
Acetaminophen Extra Strength | Physicians Total Care, Inc.
Do not take more than directed.
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 doctorChildren 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. - Western Family Foods Inc
Acetaminophen Extra Strength | Western Family Foods Inc
• do not take more than directed (see overdose warning)adults and children 12 years and over
• take 2 geltabs every 6 hours while symptoms last • do not take more than 6 geltabs in 24 hours, unless directed by a doctor • do not use for more than 10 days unless directed by a doctorchildren under 12 years
ask a doctor
- Western Family Foods Inc
Acetaminophen Extra Strength | Western Family Foods 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 doctorchildren under 12 years
ask a doctor
- Equate (Walmart Stores, Inc.)
Acetaminophen Extra Strength | Equate (walmart Stores, 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 do not take for more than 10 days unless directed by a doctor children under 12 years: do not use - Family Dollar (Family Wellness)
Acetaminophen Extra Strength | Family Dollar (family Wellness)
Directions 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 do not take for more than 10 days unless directed by a doctor children under 12 years: do not use - Family Dollar (Family Wellness)
Acetaminophen Extra Strength | Family Dollar (family Wellness)
Directions do not take more than directed (see overdose warning) adults and children 12 years and over: take 2 gelcaps every 6 hours while symptoms last do not take more than 6 gelcaps in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years: do not use - Save-a-lot Food Stores, Ltd.
Acetaminophen Extra Strength | Save-a-lot Food Stores, Ltd.
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 - Assured / Dollar Tree (Greenbrier International, Inc.)
Acetaminophen Extra Strength | Assured / Dollar Tree (greenbrier International, 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 8 tablets in 24 hours do not take for more than 10 days unless directed by a doctor children under 12 years: do not use - Save-a-lot Food Stores, Ltd.
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