Label: CETIRIZINE HYDROCHLORIDE- cetirizine tablet
- NDC Code(s): 65162-045-03, 65162-045-50
- Packager: Amneal Pharmaceuticals LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated August 8, 2023
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- Official Label (Printer Friendly)
- SPL UNCLASSIFIED SECTION
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS AND USAGE
- WARNINGS
- ASK DOCTOR
- ASK DOCTOR/PHARMACIST
- STOP USE
- PREGNANCY OR BREAST FEEDING
- KEEP OUT OF REACH OF CHILDREN
-
DIRECTIONS
Adults and children 6years and over 1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10 mg) in 24 hours. Adults 65years and over 1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours. Children under 6 years of age ask a doctor Consumers with liver or kidney disease ask a doctor - OTHER INFORMATION
- INACTIVE INGREDIENTS
- OTC - QUESTIONS
- SPL UNCLASSIFIED SECTION
- 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:65162-045 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 5 mg Inactive Ingredients Ingredient Name Strength LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990) POLYETHYLENE GLYCOL, UNSPECIFIED (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 6mm Flavor Imprint Code IP;45 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:65162-045-03 1 in 1 CARTON 01/21/2010 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:65162-045-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 01/21/2010 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078780 01/21/2010 Labeler - Amneal Pharmaceuticals LLC (123797875) Establishment Name Address ID/FEI Business Operations Amneal Pharmaceuticals of New York, LLC 831227801 analysis(65162-045) , label(65162-045) , manufacture(65162-045) , pack(65162-045)