Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.
*Compared to the active ingredient in Tylenol®
(in each tablet)
Acetaminophen 325 mg
Pain Reliever/Fever Reducer
for the temporary relief of minor aches and pains due to:
Minor pain of arthritis
The common cold
Premenstrual and menstrual cramps
Temporarily reduces fever.
This product contains acetaminophen. Severe liver damage may occur if
adult takes more than 12 tablets in 24 hours, which is the maximum daily amount
child takes more than 5 doses in 24 hours
taken with other drugs containing acetaminophen
adult has 3 or more alcoholic drinks every day while using this product
Do not use
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
Ask a doctor before use if the user has liver disease.
Ask a doctor or pharmacist before use if the user is taking the blood thinning drug warfarin.
Stop use and ask a doctor if
Pain gets worse or lasts more than 10 days in adults and children
Pain gets worse or lasts more than 5 days in children under 12 years
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.
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children.
Taking more than the recommended dose (overdose) may cause liver damage. 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.
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 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.