Label: CETIRIZINE HYDROCHLORIDE tablet, coated

  • NDC Code(s): 62207-764-49, 62207-764-55
  • Packager: Granules India Ltd
  • Category: HUMAN OTC DRUG LABEL

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 years and overask a doctor
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

  • 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

    62207-764-73-carton-jpg62207-764-73-blisterpacking-jpgcet1000s

    cet14s

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:62207-764
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    Product Characteristics
    Colorwhite (white to off white) Score2 pieces
    ShapeRECTANGLE (rounded off rectangualr) Size9mm
    FlavorImprint Code G;4
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:62207-764-5514 in 1 BOTTLE; Type 0: Not a Combination Product05/28/2018
    2NDC:62207-764-491000 in 1 BOTTLE; Type 0: Not a Combination Product05/28/2018
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20927405/28/2018
    Labeler - Granules India Ltd (915000087)
    Establishment
    NameAddressID/FEIBusiness Operations
    Granules India Ltd918609236manufacture(62207-764)
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