ACETAMINOPHEN
-
acetaminophen tablet
Amneal Pharmaceuticals
*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:
Temporarily reduces fever.
Liver warning:
This product contains acetaminophen. Severe liver damage may occur if
Do not use
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
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
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. |
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
ACETAMINOPHEN
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Marketing Information | |||
Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
OTC monograph final | part343 | 12/16/2009 |
Labeler - Amneal Pharmaceuticals (804220023) |
Registrant - Amneal Pharmaceuticals (831227801) |
Establishment | |||
Name | Address | ID/FEI | Operations |
Gemini Pharmaceuticals Inc. | 055942270 | ANALYSIS, MANUFACTURE |