Label: CETIRIZINE HYDROCHLORIDE- cetirizine tablet

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

Drug Label Information

Updated February 6, 2013

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  • ACTIVE INGREDIENT (IN EACH TABLET)

    Cetirizine HCl, USP 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 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 (1-800-222-1222).

  • DIRECTIONS

    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

    • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SEAL IS BROKEN OR MISSING FROM BOTTLE.
    • store between 20° to 25° C (68° to 77° F)
  • INACTIVE INGREDIENTS

    Corn starch, hypromellose, lactose monohydrate, magnesium stearate, polyethylene glycol, povidone, talc, titanium dioxide

  • QUESTIONS?

    Call 1-800-406-7984

  • PRINCIPAL DISPLAY PANEL

    SHOPKO®

    †Compare to the Active Ingredient of Zyrtec®

    Original Prescription Strength

    Allergy Relief

    Cetirizine HCl Tablets, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 Hour Relief of:

    Sneezing, Runny Nose, Itchy/Watery Eyes, Itchy Throat or Nose

    30 Tablets 10 mg Each

    Manufacturedby: Ohm Laboratories Inc.

    5093681/R0212

    30's bottle carton label.

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:37012-939
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TALC (UNII: 7SEV7J4R1U)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    ColorwhiteScoreno score
    ShapeRECTANGLE (Rounded Off) Size9mm
    FlavorImprint Code R152
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:37012-939-1414 in 1 BLISTER PACK
    2NDC:37012-939-3030 in 1 BOTTLE
    3NDC:37012-939-0575 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07749812/27/2007
    Labeler - Shopko Stores Operating Co., LLC (023252638)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    NameAddressID/FEIBusiness Operations
    Ohm Laboratories Inc.184769029manufacture(37012-939)
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