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.
Active Ingredients (in each tablet)
Pain Reliever/fever reducer
this product contains acetaminophen. Severe liver damage may occur if you take
more than 8 tablets in 24 hours, which is the maxium daily amount
with other drugs containing acetaminophen
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 you have
Ask a doctor or pharmacist before use if you are
taking the blood thinning drug warfarin
Stop use and ask a doctor if
new symptoms occur
redness or swelling is present
pain gets worse or lasts for more than 10 days
fever gets worse or lasts for more than 3 days
These could be sign of a serious condition
If pregnant or breast-feeding
ask a health professional before use.
Keep out of reach of children.
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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. 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 (see overdose warning)
adults and children 12 years and over
take 2 tablets every 4 to 6 house as needed
do not take more than 8 tablets in 24 hours
do not use for more than 10 days unless directed by a doctor
children under 12 years
do not use this adult Extra Strength product in children under 6 years of age; this will provide more than the recommended dose (overdose) and may cause liver damage
do not use if imprinted safety seal under cap is broken or missing.