Label: CETIRIZINE HYDROCHLORIDE tablet, film coated
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Contains inactivated NDC Code(s)
NDC Code(s): 66116-417-30 - Packager: MedVantx, Inc.
- This is a repackaged label.
- Source NDC Code(s): 16714-271
- Category: HUMAN OTC DRUG LABEL
Drug Label Information
Updated May 27, 2013
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- Official Label (Printer Friendly)
- 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 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
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- drowsiness may occur
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- avoid alcoholic drinks
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- alcohol, sedatives, and tranquilizers may increase drowsiness
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- 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 or comments?
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
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INGREDIENTS AND APPEARANCE
CETIRIZINE HYDROCHLORIDE
cetirizine hydrochloride tablet, film coatedProduct Information Product Type HUMAN OTC DRUG Item Code (Source) NDC:66116-417(NDC:16714-271) 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 STARCH, CORN (UNII: O8232NY3SJ) LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X) POVIDONE K29/32 (UNII: 390RMW2PEQ) MAGNESIUM STEARATE (UNII: 70097M6I30) Product Characteristics Color WHITE Score no score Shape CAPSULE Size 9mm Flavor Imprint Code S;521 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:66116-417-30 30 in 1 BOTTLE, PLASTIC Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date ANDA ANDA078862 10/19/2009 Labeler - MedVantx, Inc. (806427725) Registrant - Northstar Rx LLC (830546433) Establishment Name Address ID/FEI Business Operations Blenheim Pharmacal, Inc. 171434587 REPACK(66116-417)