Label: INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS- cetirizine hydrochloride capsule

  • NDC Code(s): 59779-415-25, 59779-415-30, 59779-415-40
  • Packager: CVS Pharmacy
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 08/14

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

  • Active Ingredient (in each capsule)

     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.

    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
    • alcohol, sedatives, and tranquilizers may increase drowsiness
    • avoid alcoholic drinks
    • be careful when driving a motor vehicle or operating machinery

    Stop use and ask a doctor if

    an allergic reation 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.

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  • Directions

    adults and children 6 years and over one 10 mg capsule once daily; do not take more than one 10 mg capsule 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°-25°C (68°-77°F)
    • avoid high humidity and excessive heat above 40°C (104°F)
    • protect from light
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  • Inactive ingredients

    FD&C yellow #6, gelatin, glycerin, mannitol, pharmaceutical ink, polyethylene glycol, purified water, sodium hydroxide, sorbitan, sorbitol

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  • Questions or comments?

    Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

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  • Principal Display Panel

    Compare to the active ingredient in ZYRTEC®*

    Original Prescription Strength

    24 HOUR Symptom Relief

    INDOOR & OUTDOOR ALLERGY RELIEF

    CETIRIZINE HYDROCHLORIDE SOFTGELS 10 mg / ANTIHISTAMINE

    24 hour relief of:

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

    Softgels†

    †Liquid-filled capsules

    *This product is not manufactured or distributed by McNeil Consumer Healthcare, owner of the registered trademark ZYRTEC®.

    TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

    KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    Distributed by: CVS Pharmacy, Inc.

    One CVS Drive, Woonsocket, RI  02895

    www.cvs.com   1-800-SHOP-CVS 

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  • Package Label

     Cetirizine HCl 10 mg

    CVS Pharmacy Indoor & Outdoor Allergy Relief

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  • INGREDIENTS AND APPEARANCE
    INDOOR/OUTDOOR ALLERGY RELIEF SOFTGELS 
    cetirizine hydrochloride capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:59779-415
    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
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    Product Characteristics
    Color YELLOW Score no score
    Shape CAPSULE Size 7mm
    Flavor Imprint Code CET
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:59779-415-30 1 in 1 PACKAGE
    1 30 in 1 BOTTLE, PLASTIC
    2 NDC:59779-415-25 1 in 1 PACKAGE
    2 25 in 1 BOTTLE, PLASTIC
    3 NDC:59779-415-40 1 in 1 PACKAGE
    3 40 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022429 03/01/2013
    Labeler - CVS Pharmacy (062312574)
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