Label: CETIRIZINE HYDROCHLORIDE tablet, chewable

  • NDC Code(s): 40032-652-03, 40032-652-10, 40032-652-30, 40032-653-03, view more
    40032-653-10, 40032-653-30
  • Packager: Novel Laboratories, Inc.
  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated December 20, 2019

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  • Active Ingredient in each chewable tablet

    For 5 mg:

    Cetirizine hydrochloride 5 mg

    For 10 mg:

    Cetirizine hydrochloride 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
  • WARNINGS

    Do not use if you have ever had an allergic reactions 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 the reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away at (1-800-222-1222).

  • Directions

    • may be taken with or without water

    For Cetirizine Hydrochloride Chewable Tablets, 5 mg

    adults and children 6 years
    		1 to 2 tablets once daily depending upon severity of symptoms; do not take
    and over
    		more than 2 tablets in 24 hours.
    adults 65 years and over
    		1 tablet once a day; do not take more than 1 tablet in 24 hours


    children under 6 years of
    		ask a doctor
    age

    consumers with liver or
    		ask a doctor
    kidney disease

    For Cetirizine Hydrochloride Chewable Tablets, 10 mg

    adults and children 6
    		one 10 mg tablet once daily; do not take more than one 10 mg tablet in 24 hours. A
    years and over
    		5 mg product may be appropriate for less severe symptoms.
    adults 65 years and
    		ask a doctor
    over

    children under 6 years of age
    		ask a doctor
    consumers with liver
    		ask a doctor
    or kidney disease

    Other information

    • store between 20° to 25°C (68° to 77°F)
    • Do not use if individual blister unit is open or torn
  • Inactive Ingredients

    acesulfame potassium, colloidal silicon dioxide, D&C YELLOW # 10, FD&C RED # 40, FD&C YELLOW # 6, low substituted hydroxypropyl cellulose, magnesium stearate, microcrystalline cellulose, polacrilex resin, sodium starch glycolate, sucralose and tutti frutti flavor

  • QUESTIONS

    Call 1-866-403-7592

    Manufactured by:

    Novel Laboratories, Inc.

    Somerset, NJ 08873

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    For 5 mg Allergy:

    NDC 40032-653-03

    Children's

    Cetirizine Hydrochloride Chewable Tablets

    5 mg

    ALLERGY

    Antihistamine

    Indoor & Outdoor Allergies

    Tutti-frutti Flavor

    6 yrs. & older

    30 CHEWABLE TABLETS

    Container Label

    C:\Users\kvyas\Desktop\Cetirizine HCL\container 1.jpg
    C:\Users\kvyas\Desktop\Cetirizine HCL\container 2.jpg
    C:\Users\kvyas\Desktop\Cetirizine HCL\container 3.jpg

    Container Carton

    C:\Users\kvyas\Desktop\Cetirizine HCL\container carton.jpg

    For 10 mg Allergy:

    NDC 40032-652-31

    Children's

    Cetirizine Hydrochloride Chewable Tablets

    10 mg

    ALLERGY

    Antihistamine

    Indoor & Outdoor Allergies

    Tutti-frutti Flavor

    6 yrs. & older

    Blister Label

    C:\Users\kvyas\Desktop\Cetirizine HCL\blister.jpg

    Blister Carton

    NDC 40032-652-30

    C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton front.jpg
    C:\Users\kvyas\Desktop\Cetirizine HCL\blistercarton back.jpg
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-653
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    POLACRILIN (UNII: RCZ785HI7S)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize7mm
    FlavorTUTTI FRUTTIImprint Code n;5
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40032-653-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/08/2016
    2NDC:40032-653-303 in 1 CARTON03/08/2016
    210 in 1 BLISTER PACK; Type 0: Not a Combination Product
    3NDC:40032-653-031 in 1 CARTON03/08/2016
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20679303/08/2016
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:40032-652
    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
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    HYDROXYPROPYL CELLULOSE, LOW SUBSTITUTED (UNII: 2165RE0K14)  
    POLACRILIN (UNII: RCZ785HI7S)  
    ACESULFAME POTASSIUM (UNII: 23OV73Q5G9)  
    SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    Product Characteristics
    ColoryellowScoreno score
    ShapeROUNDSize10mm
    FlavorTUTTI FRUTTIImprint Code n;10
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:40032-652-303 in 1 CARTON03/08/2016
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:40032-652-101000 in 1 BOTTLE; Type 0: Not a Combination Product03/08/2016
    3NDC:40032-652-031 in 1 CARTON03/08/2016
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20679303/08/2016
    Labeler - Novel Laboratories, Inc. (793518643)
    Registrant - Novel Laboratories, Inc. (793518643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novel Laboratories, Inc.793518643analysis(40032-653, 40032-652) , manufacture(40032-653, 40032-652)
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