Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablets tablet, film coated
- NDC Code(s): 62011-0414-1, 62011-0414-2, 62011-0414-3
- Packager: Strategic Sourcing Services LLC
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated December 3, 2020
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- SPL UNCLASSIFIED SECTION
- Active ingredient (in each tablet)
- Purpose
- Uses
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Warnings
Do not use if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistaminecontaining 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
- Principal Display Panel
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablets tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:62011-0414 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:62011-0414-1 1 in 1 CARTON 11/12/2019 1 30 in 1 BOTTLE; Type 0: Not a Combination Product 2 NDC:62011-0414-2 1 in 1 CARTON 11/12/2019 2 60 in 1 BOTTLE; Type 0: Not a Combination Product 3 NDC:62011-0414-3 1 in 1 CARTON 11/12/2019 3 90 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 11/12/2019 Labeler - Strategic Sourcing Services LLC (116956644)