ACETAMINOPHEN 500 MG ROUND- acetaminophen tablet 
Granules India Limited

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Acetaminophen tablets USP 500 mg (Round)

apap-500-mg-red

ACETAMINOPHEN 500 MG  ROUND
acetaminophen tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-538
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ACETAMINOPHEN (UNII: 362O9ITL9D) (ACETAMINOPHEN - UNII:362O9ITL9D) ACETAMINOPHEN500 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorredScoreno score
ShapeROUNDSize11mm
FlavorImprint Code L;1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-538-8715000 in 1 BOX; Type 0: Not a Combination Product02/13/2023
2NDC:62207-538-8590000 in 1 BOX; Type 0: Not a Combination Product02/13/2023
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only02/13/2023
Labeler - Granules India Limited (915000087)
Registrant - Granules India Limited (918609236)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Limited918609236manufacture(62207-538) , analysis(62207-538) , pack(62207-538) , label(62207-538)

Revised: 1/2023
Document Id: f339915b-70e9-3ab6-e053-2a95a90a1b91
Set id: ebe97ec1-bb02-9dc4-e053-2995a90a149d
Version: 3
Effective Time: 20230127
 
Granules India Limited