Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride tablet

  • NDC Code(s): 37012-939-05, 37012-939-14, 37012-939-30
  • Packager: Shopko Stores Operating Co., LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 02/13

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

  • ACTIVE INGREDIENT (IN EACH TABLET)

    Cetirizine HCl, USP 10 mg

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  • PURPOSE

    Antihistamine

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  • 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
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  • 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).

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  • 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
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  • 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)
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  • INACTIVE INGREDIENTS

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

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  • QUESTIONS?

    Call 1-800-406-7984

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  • 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.

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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine tablet
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:37012-939
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (CETIRIZINE) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    STARCH, CORN  
    HYPROMELLOSES  
    LACTOSE MONOHYDRATE  
    MAGNESIUM STEARATE  
    POLYETHYLENE GLYCOLS  
    POVIDONE  
    TALC  
    TITANIUM DIOXIDE  
    Product Characteristics
    Color white Score no score
    Shape RECTANGLE (Rounded Off) Size 9mm
    Flavor Imprint Code R152
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37012-939-14 14 in 1 BLISTER PACK
    2 NDC:37012-939-30 30 in 1 BOTTLE
    3 NDC:37012-939-05 75 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA077498 12/27/2007
    Labeler - Shopko Stores Operating Co., LLC (023252638)
    Registrant - Ranbaxy Pharmaceuticals Inc. (937890044)
    Establishment
    Name Address ID/FEI Business Operations
    Ohm Laboratories Inc. 184769029 manufacture(37012-939)
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