Acetaminophen
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.
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
Age | Dose |
Adults and Children 12
years and over |
|
Children 6-11 years |
|
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. |
- 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
Relabeling of "Additional Barcode Label" by:
Physicians Total Care, Inc.
Tulsa, OK 74146
Acetaminophen Tablets
325 mg
Bottles of 50 |
NDC 54868-0548-2 |
Bottles of 100 |
NDC 54868-0548-4 |
Bottles of 1000 |
NDC 54868-0548-3 |
AcetaminophenAcetaminophen TABLET
|