CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, coated 
Granules India Ltd

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Cetrizine Hydrochloride Tablets

PRINCIPAL DISPLAY PANEL

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CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-764
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
Inactive Ingredients
Ingredient NameStrength
LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
Product Characteristics
Colorwhite (white to off white) Score2 pieces
ShapeRECTANGLE (rounded off rectangualr) Size9mm
FlavorImprint Code G;4
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:62207-764-88100000 in 1 BOX06/15/2018
1NDC:62207-764-3020000 in 1 POUCH; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Export only06/15/2018
Labeler - Granules India Ltd (915000087)
Establishment
NameAddressID/FEIBusiness Operations
Granules India Ltd918609236manufacture(62207-764)

Revised: 2/2023
Document Id: f4e0965c-10e4-5b3c-e053-2995a90a4a5f
Set id: 6e5bdf93-d96b-19bc-e053-2a91aa0ad94d
Version: 2
Effective Time: 20230217
 
Granules India Ltd