Label: ACETAMINOPHEN 500 MG ROUND- acetaminophen tablet
- NDC Code(s): 62207-538-85, 62207-538-87
- Packager: Granules India Limited
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated January 27, 2023
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INGREDIENTS AND APPEARANCE
ACETAMINOPHEN 500 MG ROUND
acetaminophen tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62207-538 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 POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) STEARIC ACID (UNII: 4ELV7Z65AP) LECITHIN, SOYBEAN (UNII: 1DI56QDM62) FD&C RED NO. 40 (UNII: WZB9127XOA) POVIDONE K30 (UNII: U725QWY32X) FD&C YELLOW NO. 6 (UNII: H77VEI93A8) STARCH, CORN (UNII: O8232NY3SJ) SUCRALOSE (UNII: 96K6UQ3ZD4) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color red Score no score Shape ROUND Size 11mm Flavor Imprint Code L;1 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-538-87 15000 in 1 BOX; Type 0: Not a Combination Product 02/13/2023 2 NDC:62207-538-85 90000 in 1 BOX; Type 0: Not a Combination Product 02/13/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 02/13/2023 Labeler - Granules India Limited (915000087) Registrant - Granules India Limited (918609236) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 manufacture(62207-538) , analysis(62207-538) , pack(62207-538) , label(62207-538)
