- Active ingredient
- Purpose
- Uses
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Warnings
Liver warning: This product contains acetaminophen. Severe liver damage may occur if you takemore than 4000 mg of acetaminophen in 24 hours with other drugs containing acetaminophen 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
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
- Keep Out of Reach of Children
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Directions
Adults and children 12 years of age and older: Take 2 tablets (1,000 mg) every 6 hours while symptoms last. Do not take more than 6 tablets (3,000 mg) in 24 hours, unless directed by a doctor.
Children under 12 years of age: Do not use this extra strength product. This will provide more than the recommended dose (overdose) and could cause serious health problems.
- Inactive Ingredients
- Package/Label Principal Display Panel
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INGREDIENTS AND APPEARANCE
PAIN RELIEF EXTRA STRENGTH
acetaminophen 500 mg tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69168-235 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 500 mg Inactive Ingredients Ingredient Name Strength STARCH, CORN (UNII: O8232NY3SJ) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Other Ingredients Ingredient Kind Ingredient Name Quantity May contain POVIDONES (UNII: FZ989GH94E) May contain SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B) Product Characteristics Color WHITE Score no score Shape ROUND Size 12mm Flavor Imprint Code AZ235 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69168-235-50 50 in 1 BOTTLE; Type 0: Not a Combination Product 12/17/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC monograph not final part343 12/17/2014 Labeler - Allegiant Health (079501930) Registrant - Allegiant Health (079501930) Establishment Name Address ID/FEI Business Operations Allegiant Health 079501930 ANALYSIS(69168-235) , LABEL(69168-235) , MANUFACTURE(69168-235) , PACK(69168-235) , RELABEL(69168-235) , REPACK(69168-235)