Label: CETIRIZINE HYDROCHLORIDE tablet, chewable

  • NDC Code(s): 47335-343-15, 47335-343-16, 47335-344-15, 47335-344-16
  • Packager: Sun Pharmaceutical Industries, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 26, 2018

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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


    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
    • dizziness or loss of consciousness
    • swelling of tongue
    • swelling in or around mouth
    • trouble speaking
    • drooling
    • wheezing or problems breathing

    These symptoms may be signs of anaphylactic shock. This condition can be life threatening if not treated by a 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 occurring. 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 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.
    • 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. (1-800-222-1222)

  • Directions


    • may be taken with or without water

    For 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 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 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

  • Principal Display Panel


    For 5 mg Hives Relief:
    Original Prescription Strength
    NDC 47335-343-16
    Children's
    Cetirizine Hydrochloride Chewable Tablets
    5 mg
    HIVES Relief
    Antihistamine
    24 hour Relief of ITCHING Due to Hives
    Tutti-frutti Flavor
    6 yrs. & older
    100 CHEWABLE TABLETS
    SUN PHARMACEUTICAL INDUSTRIES LTD.


    label-5mg-hives-1

    label-5mg-hives-2

    label-5mg-hives-3

    label-5mg-hives-4

    label-5mg-hives-5

    For 10 mg Hives Relief:
    Original Prescription Strength
    NDC 47335-344-16
    Children's
    Cetirizine Hydrochloride Chewable Tablets
    10 mg
    HIVES Relief
    Antihistamine
    Tutti-frutti Flavor
    6 yrs. & older
    100 CHEWABLE TABLETS
    SUN PHARMACEUTICAL INDUSTRIES LTD.


    label-10mg-hives-1

    label-10mg-hives-2

    label-10mg-hives-3

    label-10mg-hives-4

    label-10mg-hives-5
  • 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: 68401960MK)  
    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:47335-343-1530 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2011
    2NDC:47335-343-16100 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09014209/26/2011
    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: 68401960MK)  
    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:47335-344-1530 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2011
    2NDC:47335-344-16100 in 1 BOTTLE; Type 0: Not a Combination Product09/26/2011
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09014209/26/2011
    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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