Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2019

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  • Active Ingredient ( in each chewable tablet ) 

    Cetirizine Hydrochloride 5 mg

    Cetirizine Hydrochloride 10 mg

  • Purpose

    Antihistamine

  • Uses:

    temporarily relieves these symptoms due to hay fever or other upper respiratory allergies:

    • runny nose

    • itchy, watery eyes

    • sneezing

    • itching of the nose or throat

  • 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 a 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 at (1-800-222-1222).

  • Directions:

    ● may be taken with and without water

    For Cetirizine hydrochloride chewable tablets 5 mg

    adults and children 6 years and over

    1 to 2 tablets once daily depending upon severity of symptoms; do not take 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 age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

    For Cetirizine hydrochloride chewable tablets 10 mg

    adults and children 6 years and over

    one 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 over

    ask a doctor

    children under 6 years of age

    ask a doctor

    consumers with liver or kidney disease

    ask a doctor

    Other information:

    • store between 20º to 25º C (68º to 77º F)

    • Phenylketonurics: Contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg

    • Phenylketonurics: Contains 3.36 mg Phenylalanine (a component of Aspartame) per 10 mg

    • do not use if carton is opened or if blister unit is broken.

    • see bottom panel for lot number and expiration date.

  • Inactive ingredients:

    acesulfame potassium, artificial and natural flavors, aspartame, betadex, colloidal silicon dioxide, croscarmellose sodium, dl-alpha-tocopherol, ethyl cellulose, FD&C yellow # 6 aluminum lake, fumaric acid, hypromellose, magnesium stearate, mannitol, maltodextrin, microcrystalline cellulose and talc.

  • Questions? call 1-800-313-4623

    Manufactured by:
    Jubilant Generics Ltd.
    Roorkee-247661, India

    Marketed by:
    Jubilant Cadista Pharmaceuticals Inc.
    Salisbury, MD 21801, USA

    Revised : November / 2014

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    CADISTA                               NDC 59746-285-32

    Children's
    Cetirizine Hydrochloride Chewable Tablets 5 mg
    Antihistamine 

    ALLERGY

    Phenylketonurics: contains 1.68 mg Phenylalanine (a component of Aspartame) per 5 mg tablets.

    Indoor & Outdoor Allergies
    24 hour Relief of
    ●  Sneezing 
    ●  Running Nose
    ●  Itchy,Watery Eyes
    ●  Itchy Throat or Nose

    TAMPER EVIDENT : Do not use if blister unit is broken or torn.

    6 yrs. & older
    5 mg each

    30 Chewable Tablets                  Orange Chewables
    5 mg each

    5mgcarton

    CADISTA                               NDC 59746-286-32

    Children's

    Cetirizine Hydrochloride Chewable Tablets 10 mg
    Antihistamine     

    ALLERGY

    Phenylketonurics: contains 3.36 mg Phenylalanine ( a component of Aspartame) per 10 mg tablets.

    Indoor & Outdoor Allergies
    24 hour Relief of 
    ●  Sneezing 
    ●  Running Nose
    ●  Itchy,Watery Eyes
    ●  Itchy Throat or Nose

    TAMPER EVIDENT : Do not use if blister unit is broken or torn.

    6 yrs. & older
    10 mg each

    30 Chewable Tablets         Orange Chewables
    10 mg each 

    10mgcarton
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE  
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59746-285
    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)  
    Aspartame (UNII: Z0H242BBR1)  
    Betadex (UNII: JV039JZZ3A)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    .alpha.-tocopherol, Dl- (UNII: 7QWA1RIO01)  
    Ethylcelluloses (UNII: 7Z8S9VYZ4B)  
    Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
    Fumaric Acid (UNII: 88XHZ13131)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Mannitol (UNII: 3OWL53L36A)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Talc (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize8mm
    FlavorORANGEImprint Code C285
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59746-285-323 in 1 CARTON02/19/2015
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09111602/19/2015
    CETIRIZINE HYDROCHLORIDE  
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59746-286
    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)  
    Aspartame (UNII: Z0H242BBR1)  
    Betadex (UNII: JV039JZZ3A)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    .alpha.-tocopherol, Dl- (UNII: 7QWA1RIO01)  
    Ethylcelluloses (UNII: 7Z8S9VYZ4B)  
    Fd&c Yellow No. 6 (UNII: H77VEI93A8)  
    Fumaric Acid (UNII: 88XHZ13131)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Mannitol (UNII: 3OWL53L36A)  
    Maltodextrin (UNII: 7CVR7L4A2D)  
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Talc (UNII: 7SEV7J4R1U)  
    Product Characteristics
    ColorORANGEScoreno score
    ShapeROUNDSize11mm
    FlavorORANGEImprint Code C286
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59746-286-323 in 1 CARTON02/19/2015
    110 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09111602/19/2015
    Labeler - Jubilant Cadista Pharmaceuticals Inc. (022490515)
    Registrant - Jubilant Generics Limited (650801538)
    Establishment
    NameAddressID/FEIBusiness Operations
    Jubilant Generics Limited Roorkee650369221MANUFACTURE(59746-285, 59746-286)
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