The product labeling information includes all published material associated to a drug. Product labeling documents include information like generic names, active ingredients, ingredient strength dosage, routes of administration, appearance, usage, warnings, inactive ingredients, etc.
Otc - Active Ingredient
Active ingredient (in each tablet)
Acetaminophen 325 mg
Otc - Purpose
Pain reliever/fever reducer
Indications & Usage
- Usestemporarily relieves minor aches and pains due to:headachethe common coldbackacheminor pain of arthritistoothachemuscular achespremenstrual and menstrual crampstemporarily reduces fever
- WarningsLiver warning: This product contains acetaminophen. The maximum daily dose of this product is 10 tablets (3,250 mg) in 24 hours for adults or 5 tablets (1,625 mg) in 24 hours for children. Severe liver damage may occur if
- Adult takes more than 4,000 mg of acetaminophen in 24 hourschild takes more than 5 doses in 24 hours, which is the maximum daily amounttaken with other drugs containing acetaminophenadult has 3 or more alcoholic drinks every day while using this productAllergy alert: Acetaminophen may cause severe skin reactions. Symptoms may include:
- Skin reddeningblistersrashIf a skin reaction occurs, stop use and seek medical help right away.
Otc - Do Not Use
- Do not usewith 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
Otc - Ask Doctor
Ask a doctor before use if you have liver disease
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin
Otc - Stop Use
- Stop using and ask a doctor ifpain gets worse or lasts more than 10 days in adultspain gets worse or lasts more than 5 days in children under 12 yearsfever gets worse or lasts more than 3 daysnew symptoms occurredness or swelling is presentThese could be signs of a serious condition.
Otc - Pregnancy Or Breast Feeding
If pregnant or breast-feeding, ask a health professional before use.
Otc - Keep Out Of Reach Of Children
Keep out of reach of children.
In case of accidental overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away. Prompt medical attention is critical for adults as well as for children even if you do not notice any signs or symptoms.
Dosage & Administration
- Directionsdo not take more than directedadults and children 12 years and overtake 2 tablets (650 mg) every 4 to 6 hours while symptoms lastdo not take more than 10 tablets (3,250 mg) in 24 hours, unless directed by a doctordo not use for more than 10 days unless directed by a doctorchildren 6 years to under 12 yearstake 1 tablet (325 mg) every 4 to 6 hours while symptoms lastdo not take more than 5 tablets (1,625 mg) in 24 hoursdo not use for more than 5 days unless directed by a doctorchildren under 6 years
- Ask a doctor
- Other informationSODIUM FREEstore at 25°C (77°F) excursions permitted between 15°-30°C (59°-86°F)use by expiration date on package
Inactive ingredients povidone, pregelatinized starch, sodium starch glycolate*, stearic acid *may contain this ingredient
Otc - Questions
Questions or comments? Call 1-877-290-4008
* Please review the disclaimer below.