Label: CETIRIZINE- cetiirizine tablet
- NDC Code(s): 51316-764-65
- Packager: CVS PHARMACY, INC
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated November 18, 2024
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- Download DRUG LABEL INFO: PDF XML
- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
- Do not use
- Ask a doctor before use if you have
- Ask a doctor or pharmacist before use if you are
- When using this product
- Stop use and ask a doctor if
- If pregnant or breast-feeding:
- Keep out of reach of children.
-
Directions
adults and children 6 years and over ■ one 10 mg tablet once daily; do not
take more than one 10 mg tablet in
24 hours. A 5 mg product may be
appropriate for less severe symptoms.adults 65 years and over ■ ask a doctor
children under 6 years of age ■ ask a doctor
consumers with liver or ■ ask a doctor
kidney disease - Other information
- Inactive ingredients
- Questions?
- PDP
-
INGREDIENTS AND APPEARANCE
CETIRIZINE
cetiirizine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:51316-764 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) SILICON DIOXIDE (UNII: ETJ7Z6XBU4) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) MAGNESIUM STEARATE (UNII: 70097M6I30) CROSCARMELLOSE SODIUM (UNII: M28OL1HH48) CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U) HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white (white to off white) Score 2 pieces Shape RECTANGLE (rounded off rectangular) Size 9mm Flavor Imprint Code G;4 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:51316-764-65 365 in 1 BOTTLE; Type 0: Not a Combination Product 10/16/2023 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA209274 10/16/2023 Labeler - CVS PHARMACY, INC (062312574)