CETIRIZINE HYDROCHLORIDE tablet, coated

Cetirizine hydrochloride by

Drug Labeling and Warnings

Cetirizine hydrochloride by is a Otc medication manufactured, distributed, or labeled by Granules India Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

CETIRIZINE HYDROCHLORIDE 
cetirizine hydrochloride tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 62207-764
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24)	CETIRIZINE HYDROCHLORIDE	10 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (white to off white)	Score	2 pieces
Shape	RECTANGLE (rounded off rectangualr)	Size	9mm
Flavor		Imprint Code	G;4
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 62207-764-88	100000 in 1 BOX	06/15/2018
1	NDC: 62207-764-30	20000 in 1 POUCH; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Export only		06/15/2018

Labeler - Granules India Ltd (915000087)

Establishment
Name	Address	ID/FEI	Business Operations
Granules India Ltd		918609236	manufacture(62207-764)