Label: CETIRIZINE HYDROCHLORIDE- cetirizine tablet
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Contains inactivated NDC Code(s)
NDC Code(s): 65162-046-03, 65162-046-50 - Packager: Amneal Pharmaceuticals
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated February 22, 2012
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- Official Label (Printer Friendly)
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
- DO NOT USE
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- WARNINGS
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
- DOSAGE AND ADMINISTRATION
- OTHER INFORMATION
- INACTIVE INGREDIENT
- OTC - QUESTIONS
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:65162-046 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) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL (UNII: 532B59J990) POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TALC (UNII: 7SEV7J4R1U) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 8mm Flavor Imprint Code IP;46 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65162-046-03 1 in 1 CARTON 1 30 in 1 BOTTLE 2 NDC:65162-046-50 500 in 1 BOTTLE Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078780 01/21/2010 Labeler - Amneal Pharmaceuticals (123797875) Registrant - Amneal Pharmaceuticals (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals 831227801 ANALYSIS, LABEL, MANUFACTURE, PACK