Label: CETIRIZINE HYDROCHLORIDE TABLETS,10 MG- cetirizine hydrochloride tablet
- NDC Code(s): 49483-692-01, 49483-692-20, 49483-692-50, 49483-692-65
- Packager: TIME CAP LABORATORIES, INC.
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated March 6, 2024
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- DRUG FACTS
- ACTIVE INGREDIENT
- PURPOSE
- INDICATIONS & USAGE
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WARNINGS
Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients, or to an antihistamine containing hydroxyzine.
Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
When using this product:
• drowsiness may occur
• avoid alcoholic drinks
• alcohol, sedatives, and tranquilizers may increase drowsiness
• be careful when driving a motor vehicle or operating machinery
Stop use and ask a doctor if an allergic reaction to this product occurs. Seek medical help right away.
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DOSAGE & ADMINISTRATION
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 kidney disease ask a doctor - OTHER SAFETY INFORMATION
- INACTIVE INGREDIENT
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE TABLETS,10 MG
cetirizine hydrochloride tabletProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:49483-692 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 TITANIUM DIOXIDE (UNII: 15FIX9V2JP) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) STARCH, CORN (UNII: O8232NY3SJ) POVIDONE K30 (UNII: U725QWY32X) MAGNESIUM STEARATE (UNII: 70097M6I30) HYPROMELLOSES (UNII: 3NXW29V3WO) POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A) Product Characteristics Color white (White to off white) Score no score Shape RECTANGLE (Rounded-off rectangular shaped) Size 9mm Flavor Imprint Code J;220 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:49483-692-65 365 in 1 BOTTLE; Type 0: Not a Combination Product 02/12/2022 2 NDC:49483-692-50 500 in 1 BOTTLE; Type 0: Not a Combination Product 05/30/2022 3 NDC:49483-692-01 100 in 1 BOTTLE; Type 0: Not a Combination Product 03/11/2024 4 NDC:49483-692-20 200 in 1 BOTTLE; Type 0: Not a Combination Product 03/11/2024 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078933 02/12/2022 Labeler - TIME CAP LABORATORIES, INC. (037052099) Registrant - TIME CAP LABORATORIES, INC. (037052099) Establishment Name Address ID/FEI Business Operations MARKSANS PHARMA LIMITED 925822975 manufacture(49483-692)