Label: CETIRIZINE HYDROCHLORIDE tablet, coated
- NDC Code(s): 62207-764-30, 62207-764-88
- Packager: Granules India Ltd
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Export only
Drug Label Information
Updated February 17, 2023
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, coatedProduct 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)
