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 over    		1 tablet (5 mg) or 2 tablets (10 mg) once daily depending upon severity of symptoms; do not take more than 2 tablets (10mg) in 24 hours.
    adults 65 years and over
    		1 tablet (5 mg) once daily; do not take more than 1 tablet (5 mg) in 24 hours.
    children under 6 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor

    For 10 mg:

    adults and children 6 years and overChew and swallow 1 tablet (10 mg) once daily; do not take more than 1 tablet
    (10 mg) 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

  • 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, magnesium stearate, mannitol, microcrystalline cellulose, pregelatinized starch, prosweet N & A flavor powder, talc, tutti frutti flavor

  • 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 Size
    Tutti-frutti Flavor
    6 yrs & older
    30 CHEWABLE TABLETS
    SUN PHARMACEUTICAL INDUSTRIES LTD.

    spl-cetirizine-5mg-allergy-1

    spl-cetirizine-5mg-allergy-2

    spl-cetirizine-5mg-allergy-3

    spl-cetirizine-5mg-allergy-4

    spl-cetirizine-5mg-allergy-5

    spl-cetirizine-5mg-allergy-6

    spl-cetirizine-5mg-allergy-7

  • 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 Size
    Tutti-frutti Flavor
    6 yrs & older
    30 CHEWABLE TABLETS
    SUN PHARMA

    spl-cetirizine-10mg-allergy-1

    spl-cetirizine-10mg-allergy-22

    spl-cetirizine-10mg-allergy-33

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47335-343
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE5 mg
    Inactive Ingredients
    Ingredient NameStrength
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize8mm
    FlavorTUTTI FRUTTIImprint Code 343
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47335-343-8330 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
    2NDC:47335-343-88100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09014209/09/2011
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:47335-344
    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
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCROSE (UNII: C151H8M554)  
    CROSPOVIDONE (UNII: 2S7830E561)  
    FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    GUAR GUM (UNII: E89I1637KE)  
    MAGNESIUM OXIDE (UNII: 3A3U0GI71G)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    MANNITOL (UNII: 3OWL53L36A)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    TALC (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorPURPLEScoreno score
    ShapeROUNDSize10mm
    FlavorTUTTI FRUTTIImprint Code 344
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:47335-344-8330 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
    2NDC:47335-344-88100 in 1 BOTTLE; Type 0: Not a Combination Product09/09/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09014209/09/2011
    Labeler - Sun Pharmaceutical Industries, Inc. (146974886)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Limited725959238ANALYSIS(47335-343, 47335-344) , MANUFACTURE(47335-343, 47335-344)
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