Label: ACETAMINOPHEN tablet
- NDC Code(s): 69396-140-01, 69396-140-03
- Packager: Trifecta Pharmaceuticals USA LLC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
Drug Label Information
Updated June 12, 2024
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- Official Label (Printer Friendly)
- Active Ingredient
- Purpose
- Do Not Use
- Uses
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Warnings
Liver warning
This product contains acetaminophen. Sever liver damage may occur if you take
- more than 4000mg of acetaminophen in 24 hours
- with other drugs containing acetaminophen
- 3 or more alcoholic drinks every day while using this product
Allergy alert
Acetaminophen may cause severe skin reactions. Symptoms may include
- skin reddening
- blisters
- rash
if a skin reaction occurs stop use ad seek medical medical help right away
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- Keep out of reach of children
-
Directions
Do not take more than directed. See overdose warning
Adults and children 12 years and older
- Take 2 tablets every 6 hours while symptoms last
- Do not take more than 6 tablets in 24 hours unless directed by a doctor
- Do not use for more than 10 days unless directed by a doctor
Children under 12 years of age
- Ask a doctor
- Stop Use and ask a doctor if
- If pregnant or breast-feeding
- Overdose Warning
- Other Information
- Inactive Ingredients
- Questions or Comments?
- Distributed By:
- Label
-
INGREDIENTS AND APPEARANCE
ACETAMINOPHEN
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:69396-140 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 STEARIC ACID (UNII: 4ELV7Z65AP) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STARCH, CORN (UNII: O8232NY3SJ) SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POVIDONE K30 (UNII: U725QWY32X) Product Characteristics Color white Score no score Shape ROUND Size 12mm Flavor Imprint Code G552 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:69396-140-03 10000 in 1 BAG 08/08/2023 1 2 in 1 PACKET; Type 0: Not a Combination Product 2 NDC:69396-140-01 50 in 1 BOX 08/08/2023 2 2 in 1 PACKET; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date OTC Monograph Drug M013 08/08/2023 Labeler - Trifecta Pharmaceuticals USA LLC (079424163)