Label: COMPRESSO PAP 80 DPL- acetaminophen 80% and diphenhydramine hcl 4% directly compressible granules powder
- NDC Code(s): 62207-600-10, 62207-600-13, 62207-600-19
- Packager: Granules India Limited
- Category: BULK INGREDIENT
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated February 17, 2023
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INGREDIENTS AND APPEARANCE
COMPRESSO PAP 80 DPL
acetaminophen 80% and diphenhydramine hcl 4% directly compressible granules powderProduct Information Product Type BULK INGREDIENT Item Code (Source) NDC:62207-600 Route of Administration NOT APPLICABLE Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE HYDROCHLORIDE - UNII:TC2D6JAD40) DIPHENHYDRAMINE HYDROCHLORIDE 4 mg in 100 mg ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN 80 mg in 100 mg Inactive Ingredients Ingredient Name Strength MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U) POVIDONE K30 (UNII: U725QWY32X) STEARIC ACID (UNII: 4ELV7Z65AP) STARCH, PREGELATINIZED CORN (UNII: O8232NY3SJ) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) Product Characteristics Color white (White free flowing granules) Score Shape Size Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:62207-600-13 50000000 mg in 1 DRUM 02/10/2010 2 NDC:62207-600-19 400000000 mg in 1 BAG 02/15/2016 3 NDC:62207-600-10 60000000 mg in 1 DRUM 02/10/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Export only 02/10/2010 Labeler - Granules India Limited (915000087) Establishment Name Address ID/FEI Business Operations Granules India Limited 918609236 label(62207-600) , analysis(62207-600) , manufacture(62207-600) , pack(62207-600)
