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

62207-600-1962207-600-1362207-600-10

COMPRESSO PAP 80 DPL 
acetaminophen 80% and diphenhydramine hcl 4% directly compressible granules powder
Product Information
Product TypeBULK INGREDIENTItem Code (Source)NDC:62207-600
Route of AdministrationNOT APPLICABLE
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
DIPHENHYDRAMINE HYDROCHLORIDE (UNII: TC2D6JAD40) (DIPHENHYDRAMINE HYDROCHLORIDE - UNII:TC2D6JAD40) DIPHENHYDRAMINE HYDROCHLORIDE4 mg  in 100 mg
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN80 mg  in 100 mg
Inactive Ingredients
Ingredient NameStrength
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
Colorwhite (White free flowing granules) Score    
ShapeSize
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-600-1350000000 mg in 1 DRUM02/10/2010
2NDC:62207-600-19400000000 mg in 1 BAG02/15/2016
3NDC:62207-600-1060000000 mg in 1 DRUM02/10/2010
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/10/2010
Labeler - Granules India Limited (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236label(62207-600) , analysis(62207-600) , manufacture(62207-600) , pack(62207-600)

Revised: 2/2023
Document Id: f4e53663-365e-1d50-e053-2995a90af3eb
Set id: 4a4e2aa2-3604-2806-e054-00144ff8d46c
Version: 4
Effective Time: 20230217
 
Granules India Limited