Label: CETIRIZINE HYDROCHLORIDE tablet, chewable

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

Drug Label Information

Updated December 21, 2018

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  • Active Ingredient in each chewable tablet

    Cetirizine Hydrochloride Chewable Tablets 10mg

  • 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
    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 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

    1-888-287-1915

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    Blister
    carton
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride tablet, chewable
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:49035-652
    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:49035-652-244 in 1 CARTON03/08/2016
    1NDC:49035-652-256 in 1 BLISTER PACK; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20679303/08/2016
    Labeler - Wal-Mart Stores, Inc. (051957769)
    Registrant - Novel Laboratories, Inc. (793518643)
    Establishment
    NameAddressID/FEIBusiness Operations
    Novel Laboratories, Inc.793518643ANALYSIS(49035-652) , MANUFACTURE(49035-652) , PACK(49035-652)
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