ACETAMINOPHEN EXTRA STRENGTH
acetaminophen tablet Amneal Pharmaceuticals
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 Extra Strength Tylenol®
(in each tablet)
Acetaminophen 500 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 you take
more than 8 caplets in 24 hours, which is the maximum 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 liver disease.
Ask a doctor or pharmacist before use if you are taking the blood thinning drug warfarin.
Stop use and ask a doctor if
Pain gets worse or lasts more than 10 days
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 the 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 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 doctor
Children 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.