*Compared to the active ingredient in Tylenol®
(in each tablet)
Acetaminophen 325 mg
Pain Reliever/Fever Reducer
for the temporary relief of minor aches and pains due to:
Temporarily reduces fever.
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.
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
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®.
104 Hippocrates Way,
Glasgow, KY 42141
|Application Number or Monograph Citation
|Marketing Start Date
|Marketing End Date
|OTC monograph final
|Labeler - Amneal Pharmaceuticals (804220023)
|Registrant - Amneal Pharmaceuticals (831227801)
|Gemini Pharmaceuticals Inc.