Label: CETIRIZINE HYDROCHLORIDE tablet, chewable

  • NDC Code(s): 47335-343-83, 47335-343-88, 47335-344-83, 47335-344-88
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated September 16, 2024

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  • Active ingredient (in each chewable tablet)
    For 5 mg:Cetirizine hydrochloride, USP 5 mg - For 10 mg:Cetirizine hydrochloride, USP 10 mg
  • Purpose
    Antihistamine
  • Uses
    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies: runny nose - sneezing - itchy, watery eyes - itching of the nose or throat
  • SPL UNCLASSIFIED SECTION
  • 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.
  • Ask a doctor or pharmacist before use if
    you are taking tranquilizers or sedatives.
  • 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 doctor if
    an allergic reaction to this product occurs. Seek medical help right away.
  • If pregnant or breast-feeding:
    if breast-feeding: not recommended - if pregnant: ask a health professional before use.
  • Keep out of reach of children
    In case of overdose, get medical help or contact a Poison Control Center right away. (1-800-222-1222)
  • Directions
    may be taken with or without water - chew or crush tablets completely before swallowing - For 5 mg: adults and children 6 years and over1 tablet (5 mg) or 2 tablets (10 mg) once daily ...
  • Other information
    store between 20° to 25°C (68° to 77°F) do not use if inner safety seal is open or torn - see top layer for lot number and expiration date
  • Inactive ingredients
    acesulfame potassium, colloidal silicon dioxide, compressible sugar, crospovidone, FD & C Blue No # 2 Aluminum Lake, FD & C Red No # 40 Aluminum Lake, guar gum, magnesium oxide light powder ...
  • Questions?
    Call toll free 1-800-818-4555 weekdays
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    For 5 mg Allergy: Original Prescription Strength - NDC 47335-343-83 - Cetirizine Hydrochloride Chewable Tablets - 5 mg - ALLERGY - Antihistamine - Indoor + Outdoor Allergies - Actual ...
  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
    For 10 mg Allergy: Original Prescription Strength - NDC 47335-344-83 - Cetirizine Hydrochloride Chewable Tablets - 10 mg - ALLERGY - Antihistamine - Indoor + Outdoor Allergies - Actual ...
  • INGREDIENTS AND APPEARANCE
    Product Information
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