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.
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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 you take
Do not use
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
These could be signs of a serious condition.
Keep out of reach of children.
Overdose warning: 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:
Children under 12 years:
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
EXTRA STRENGTH
acetaminophen tablet |
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ACETAMINOPHEN
EXTRA STRENGTH
acetaminophen tablet |
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Labeler - Amneal Pharmaceuticals (831227777) |
Establishment | |||
Name | Address | ID/FEI | Business Operations |
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Gemini Pharmaceuticals Inc. | 055942270 | analysis(65162-602, 65162-607) , manufacture(65162-602, 65162-607) |