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.
DISTRIBUTED BYCARDINAL HEALTHDUBLIN, OHIO 43017www.myleader.com1-800-200-6313
Otc - Active Ingredient
Active ingredient (in each tablet)Acetaminophen 325 mg
Otc - Purpose
PurposesPain reliever/fever reducer
Indications & Usage
- Usestemporarily relieves minor aches and pains due to:headachemuscular achesbackacheminor pain of arthritistoothachethe common coldpremenstrual and menstrual crampstemporarily reduces fever
- WarningsLiver warning: This product contains acetaminophen. 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 product.Allergy 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 the user has liver disease.
Otc - Ask Doctor/Pharmacist
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
Otc - Stop Use
- Stop use 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.
Overdose warning: In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222) Quick 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 directed (see overdose warning)adults and children 12 years and overtake 2 tablets every 4 to 6 hours while symptoms lastdo not take more than 10 tablets 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 yearstakes 1 tablet every 4 to 6 hours while symptoms lastdo not take more than 5 tablets in 24 hoursdo not use for more than 5 days unless directed by a doctorchildren under 6 yearsask a doctor
Storage And Handling
- Other informationstore at room temperature
Inactive ingredients Povidone, pregelatinized starch, sodium starch glycolate, stearic acid
Otc - Questions
Questions or Comments?call
Other Safety Information
Do not use if carton is open, or if imprinted safety seal under cap is broken or missing
* Please review the disclaimer below.