Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet, chewable

  • NDC Code(s): 59746-285-33, 59746-286-33
  • Packager: Jubilant Cadista Pharmaceuticals Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated December 30, 2019

If you are a consumer or patient please visit this version.

  • Active Ingredient (in each chewable tablet)

    Cetirizine Hydrochloride 5 mg 

    Cetirizine Hydrochloride 10 mg

  • Purpose

    Antihistamine

  • Uses:

    relieves itching due to hives (urticaria).

    This product will not prevent hives or an allergic skin reaction from occurring.

  • Warnings:

    Severe Allergy Warning: Get emergency help immediately if you have hives along with any of the following symptoms:

    • trouble swallowing

    • swelling of tongue

    • trouble speaking

    • wheezing or problems breathing

    • dizziness or loss of conciousness

    • swelling in or around mouth

    • drooling

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by health professional immediately. Symptoms of anaphylactic shock may occur when hives first appear or up to a few hours later.

    Not a Substitute for Epinephrine. If your doctor has prescribed an epinephrine injector for "anaphylaxis" or severe allergy symptoms that could occur with your hives, never use this product as a substitute for the epinephrine injector. If you have been prescribed an epinephrine injector, you should carry it with you at all times.

  • Do not use

    • to prevent hives from any known cause such as:

    •  foods

    •  insect stings

    •  medicines

    •  latex or rubber gloves

    because this product will not stop hives from occuring. Avoiding the cause of your hives is the only way to prevent them. Hives can sometimes be serious.

    If you do not know the cause of your hives, see your doctor for a medical exam.

    Your doctor may be able to help you find a cause.

    ●     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.

    • hives that are an unusual color, look bruised or blistered.

    • hives that do not itch.

  • Ask a doctor or pharmacist before use if you are taking transquillizers 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

    • symptoms do not improve after 3 days of treatment

    • the hives have lasted more than 6 weeks

  • 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

    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 & 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 59746-285-33 

    Children's
    Cetirizine Hydrochloride Chewable Tablets 5 mg
    Antihistamine

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

    HIVES Relief  
    24 hour Relief of Itching due to hives 

    6 yrs. & older 5 mg each
      

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

    30 Chewable Tablets                                                                              Orange Chewables
    5 mg each

    Cetirizen 5mg hives

    Cetirizine Hydrochloride Chewable Tablets 5 mg Hives Relief

    CADISTA                                                                       NDC 59746-286-33

    Children's
    Cetirizine Hydrochloride Chewable Tablets 10 mg
    Antihistamine


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

    HIVES Relief
    24 hour Relief of Itching due to hives 

    6 yrs. & older 10 mg each


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

    30 Chewable Tablets                                     Orange Chewables
    10 mg each

    Cetirizine 10mg hives

    Cetirizine Hydrochloride Chewable Tablets 10 mg Hives  Relief

  • 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:59746-285-333 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:59746-286-333 in 1 CARTON12/19/2015
    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)