Acetaminophen

Amneal Pharmaceuticals
Amneal Pharmaceuticals

Acetaminophen Tablets

FULL PRESCRIBING INFORMATION

*Compared to the active ingredient in Tylenol^®

Drug Facts

(in each tablet)

Acetaminophen 325 mg

Pain Reliever/Fever Reducer

for the temporary relief of minor aches and pains due to:

• Headache
• Muscular aches
• Backache
• Minor pain of arthritis
• The common cold
• Toothache
• Premenstrual and menstrual cramps

Temporarily reduces fever.

Liver warning:

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.

Overdose warning:

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

• Store at room temperature 15°-30°C (59°-86°F)
• Use by expiration date on package.

Povidone, Pregelatinized Starch, Sodium Starch Glycolate, Stearic Acid

Questions? To report a Serious Adverse Event contact 1-877-835-5472.

*This product is not manufactured or distributed by McNeil Consumer Products Co., owners of the registered trademark Tylenol^®.

Distributed by:

Amneal Pharmaceuticals

104 Hippocrates Way,

Glasgow, KY 42141

Rev. 11/2009