Label: 24 HOUR ALLERGY- cetirizine hcl capsule

  • NDC Code(s): 0363-1219-15, 0363-1219-86
  • Packager: Walgreens
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated September 13, 2018

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

  • Active ingredient (in each capsule)

    Cetirizine HCl 10 mg

  • Purpose

    Antihistamine

  • 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
  • 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.

  • Directions

    adults and children 6 years and overone 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

  • Other Information

    • store at 20º-25ºC (68º-77ºF)
    • avoid high humidity and excessive heat above 40ºC (104ºF)
    • protect from light
  • Inactive ingredients

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

  • Questions or comments?

    call toll free 1-888-235-2466

  • SPL UNCLASSIFIED SECTION

    ††All trademarks are property of their respective owners. This product is not affiliated with the makers/owners of Zyrtec®.

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

    KEEP THIS CARD FOR COMPLETE WARNINGS AND PRODUCT INFORMATION

    DISTRIBUTED BY: WALGREEN CO., 200 WILMOT RD., DEERFIELD, IL 60015

    100% SATISFACTION GUARANTEED walgreens.com ©2018 Walgreen Co.

  • Principal Display Panel

    ORIGINAL PRESCRIPTION STRENGTH

    Compare to Zyrtec® active ingredient††

    NDC 0363-1219-15

    Wal-ZyrTM

    24 HOUR ALLERGY

    CETIRIZINE HYDROCHLORIDE CAPSULES, 10 mg / ANTIHISTAMINE

    24 HOUR

    SOFTGELS

    INDOOR & OUTDOOR ALLERGIES

    • 24-hour relief of sneezing; runny nose; itchy, watery eyes & itchy throat or nose

    40 SOFTGELS**

    (**LIQUID-FILLED CAPSULES) 10 mg EACH

    Front

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  • INGREDIENTS AND APPEARANCE
    24 HOUR ALLERGY 
    cetirizine hcl capsule
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1219
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    CETIRIZINE HYDROCHLORIDE (UNII: 64O047KTOA) (CETIRIZINE - UNII:YO7261ME24) CETIRIZINE HYDROCHLORIDE10 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColororangeScoreno score
    ShapeOVALSize13mm
    FlavorImprint Code CE1
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1219-151 in 1 PACKAGE09/14/2018
    140 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    2NDC:0363-1219-861 in 1 BOX09/14/2018
    225 in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02242909/14/2018
    Labeler - Walgreens (008965063)
    Registrant - Bionpharma Inc. (079637826)
    Establishment
    NameAddressID/FEIBusiness Operations
    Patheon Softgels Inc.002193829manufacture(0363-1219)