Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, film coated
- NDC Code(s): 53943-519-30, 53943-519-45
- Packager: Discount Drug Mart, Inc
- This is a repackaged label.
- Source NDC Code(s): 55111-699
- Category: HUMAN OTC DRUG LABEL
- DEA Schedule: None
- Marketing Status: Abbreviated New Drug Application
Drug Label Information
Updated June 15, 2023
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- Official Label (Printer Friendly)
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
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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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 information
- Inactive ingredients
- Questions?
- PRINCIPAL DISPLAY PANEL
-
INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:53943-519(NDC:55111-699) 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 HYPROMELLOSES (UNII: 3NXW29V3WO) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) MAGNESIUM STEARATE (UNII: 70097M6I30) POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ) POVIDONE (UNII: FZ989GH94E) STARCH, CORN (UNII: O8232NY3SJ) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) Product Characteristics Color WHITE Score no score Shape OVAL Size 7mm Flavor Imprint Code C Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:53943-519-45 1 in 1 CARTON 01/20/2020 1 45 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:53943-519-30 1 in 1 CARTON 01/20/2020 2 30 in 1 BOTTLE; Type 0: Not a Combination Product Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078343 01/20/2020 Labeler - Discount Drug Mart, Inc (047741335)