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

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 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 LABEL Item Code (Source) NDC:59779-415
    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
    FD&C YELLOW NO. 6  
    GELATIN  
    GLYCERIN  
    MANNITOL  
    POLYETHYLENE GLYCOLS  
    WATER  
    SODIUM HYDROXIDE  
    SORBITAN  
    SORBITOL  
    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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