WAL-ZYR TABLET [WALGREEN COMPANY]

WAL-ZYR TABLET [WALGREEN COMPANY]
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NDC 0363-1024-01, 0363-1024-03, 0363-1024-04, 0363-1024-07
Set ID ee124853-3cf0-8154-31d8-7caf5965d709
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA078317
  • Active ingredients (in each tablet)

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

    Stop use and ask 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. (1-800-222-1222)

  • Directions

    adults and children 6 years and overone 10 mg tablet once daily; do not take more than one10 mg tablet in 24 hours.A 5 mg product may be appropriate for less severe symptoms.
    adults 65 years and overask a doctor
    children under 6 years of ageask a doctor
    consumers with liveror kidney disease ask a doctor

  • Other information

    • do not use if blister unit is broken or torn
    • store between 20°C to 25°C (68°F to 77°F)

  • Inactive ingredients

    Lactose monohydrate, microcrystalline cellulose, starch (corn), magnesium stearate, hypromellose, polydextrose, polyethylene glycol, and titanium dioxide

  • Questions

    1-800-706-5575

    * This product is not manufactured or distributed by McNeil-PPC, Inc., distributor ofZyrtec®. 

  • Principal Display Panel - 10 mg-Bottle-label-45count

    OTC Medicine

    Walgreens

    Wal-ZyrTM

    NDC# 0363-1024-04

    24 Hour Allergy

    Antihistamine

    • 24 hour symptom relief

    45 TABLETS 10 mg each

    10 mg-Bottle-label-45count

  • Principal Display Panel - 10 mg-Carton-label-45count

    OTC Medicine

    Walgreens

    Wal-ZyrTM

    Carton

    NDC# 0363-1024-04

    24 Hour Allergy

    Antihistamine

    • 24 hour symptom relief

    45 TABLETS 10 mg each

    10 mg-Carton-label-45count

  • INGREDIENTS AND APPEARANCE
    WAL-ZYR 
    wal-zyr tablet
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-1024
    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
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STARCH, CORN (UNII: O8232NY3SJ)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    CARNAUBA WAX (UNII: R12CBM0EIZ)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeRECTANGLESize9mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-1024-041 in 1 CARTON09/02/201404/30/2021
    145 in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:0363-1024-071 in 1 CARTON09/02/201404/30/2021
    270 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-1024-011 in 1 CARTON09/02/201404/30/2021
    3150 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-1024-031 in 1 CARTON09/02/201404/30/2021
    4300 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07831709/02/201404/30/2021
    Labeler - Walgreen Company (008965063)
    Registrant - Apotex Inc. (209429182)
    Establishment
    NameAddressID/FEIBusiness Operations
    Apotex Inc.209429182manufacture(0363-1024) , analysis(0363-1024)

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