Label: CETIRIZINE HYDROCHLORIDE tablet, coated

  • NDC Code(s): 70010-163-05, 70010-163-09
  • Packager: Granules Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated January 27, 2023

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  • Cetirizine Hydrochloride Tablets
    Drug Facts
  • Active Ingredient
    Cetirizine HCl 10 mg
  • PURPOSE
    Antihistamine
  • USE(S)
    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
  • 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
    liver or kidney disease. Your doctor should determine if you need a different dose.
  • ASK A DOCTOR OR PHARMACIST BEFORE USE IF
    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.
  • PREGNANCY/BREASTFEEDING
    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
    adults and children 6 years and overone 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 ...
  • STORAGE
    store between 20° to 25°C (68° to 77°F)
  • Other information
    ◾Contains no ingredient made from a gluten-containing grain (wheat, barley or rye).
  • Inactive ingredients
    colloidal silicon dioxide, croscarmellose sodium, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, titanium dioxide.
  • PRINCIPAL DISPLAY PANEL
    Cetirizine-HCl-tablets-500-ct ...
  • INGREDIENTS AND APPEARANCE
    Product Information
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