Label: ALL DAY ALLERGY- cetirizine hydrochloride capsule

  • NDC Code(s): 37205-819-63
  • Packager: Cardinal Health (Leader) 37205
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated 03/13

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 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.

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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 20º-25°C (68º-77°F)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • 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 1-800-200-6313 Monday through Friday 9AM - 5PM EST.

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  • Principal Display Panel

    Compare to Zyrtec® active ingredient†

    All Day Allergy

    Cetirizine HCl Capsules, 10 mg

    Antihistamine

    Indoor & Outdoor Allergies

    24 HOUR RELIEF OF:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • 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 CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

    DISTRIBUTED BY: CARDINAL HEALTH

    DUBLIN, OH  43017

    www.myleader.com

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  • Package Labeling

    Cetirizine HCl 10 mg

    Leader All Day Allergy Softgel

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  • INGREDIENTS AND APPEARANCE
    ALL DAY ALLERGY 
    cetirizine hcl capsule
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:37205-819
    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
    GLYCERIN (UNII: PDC6A3C0OX)  
    MANNITOL (UNII: 3OWL53L36A)  
    POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM HYDROXIDE (UNII: 55X04QC32I)  
    SORBITAN (UNII: 6O92ICV9RU)  
    SORBITOL (UNII: 506T60A25R)  
    FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
    GELATIN (UNII: 2G86QN327L)  
    Product Characteristics
    Color YELLOW Score no score
    Shape OVAL Size 13mm
    Flavor Imprint Code CET
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:37205-819-63 1 in 1 PACKAGE
    1 25 in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022429 03/03/2013
    Labeler - Cardinal Health (Leader) 37205 (097537435)
    Registrant - P and L Development of New York Corporation (800014821)
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