Label: ALL DAY ALLERGY RELIEF- cetirizine hydrochloride tablet

  • NDC Code(s): 33992-0128-4
  • Packager: ASSURED (Greenbrier International, Inc.)
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 12/12

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

  • Active Ingredient (in each tablet)

    Cetirizine HCl 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.

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  • Ask a doctor before use if you have

    liver or kidney disease.  Your doctor should determine if you need a different dose.

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  • Ask a doctor or pharmacist before use if you are

    taking tranquilizers or sedatives.

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  • 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

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  • Stop use and ask a doctor if

    an allergic reaction to this product occurs. Seek medical help right away.

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  • If pregnant or breast-feeding

    • if breast-feeding: not recommended

    • if pregnant: ask a health professional before use.

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  • Keep out of reach of children

    In case of overdose, get medical help or contact a Poison Control Center right away.

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  • Directions

    Adults and children 6 years and over  Take 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

    • store between 20 to 25°C (68 to 77°F)

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  • Inactive Ingredients

    colloidal silicon dioxide, hypromellose, lactose monohydrate, magnesium stearate, microcrystalline cellulose, polyethylene glycol, povidone, sodium starch glycolate, titanium dioxide. 

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  • Questions or comments?

    Call toll free 1-877-753-3935 Monday-Friday 9am-5pm EST.

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  • Principal Display Panel

    † Compare to the active ingredient in Zyrtec®

    All Day

    Allergy Relief

    Cetirizine Hydrochloride tablets, 10 mg

    Antihistamine

    Relief of:

    • Runny nose
    • sneezing
    • Itchy, watery eyes
    • Itchy throat or nose

    Indoor & Outdoor allergies

    †This product is not manufactured or distributed by McNeil Consumer Healthcare Division of McNeil-PPC, Inc., owner of the registered trademark Zyrtec®

    THIS PRODUCT IS PACKAGED IN A CHILD RESISTANT AND TAMPER EVIDENT PACKAGE. USE ONLY IF BLISTERS ARE INTACT.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    PRODUCT OF INDIA

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  • Package Labeling

    Assured

    Cetirizine HCl 10 mg

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  • INGREDIENTS AND APPEARANCE
    ALL DAY ALLERGY RELIEF 
    cetirizine hcl tablet
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:33992-0128
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    POVIDONES (UNII: FZ989GH94E)  
    SODIUM STARCH GLYCOLATE TYPE A CORN (UNII: AG9B65PV6B)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    Product Characteristics
    Color WHITE Score no score
    Shape ROUND Size 8mm
    Flavor Imprint Code W989
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:33992-0128-4 1 in 1 CARTON
    1 14 in 1 BLISTER PACK
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA078427 10/19/2012
    Labeler - ASSURED (Greenbrier International, Inc.) (610322518)
    Registrant - P and L Development of New York Corporation (800014821)
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