COMPRESSO PAP 80 DPL by Granules India Limited COMPRESSO PAP 80 DPL

COMPRESSO PAP 80 DPL by

Drug Labeling and Warnings

COMPRESSO PAP 80 DPL by is a Other medication manufactured, distributed, or labeled by Granules India Limited. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

COMPRESSO PAP 80 DPL- acetaminophen 80% and diphenhydramine hcl 4% directly compressible granules powder 
Granules India Limited

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COMPRESSO PAP 80 DPL

COMPRESSO PAP 80 DPL 
acetaminophen 80% and diphenhydramine hcl 4% directly compressible granules powder

Product 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)

Revised: 2/2023

Document Id: f4e53663-365e-1d50-e053-2995a90af3eb

53409-9

Set id: 4a4e2aa2-3604-2806-e054-00144ff8d46c

Version: 4

Effective Time: 20230217