WAL ZYR (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]

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WAL ZYR (CETIRIZINE HYDROCHLORIDE) TABLET, FILM COATED [WALGREEN COMPANY]
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NDC 0363-0495-06, 0363-0495-13, 0363-0495-39, 0363-0495-47, 0363-0495-58, 0363-0495-66, 0363-0495-72, 0363-0495-75, 0363-0495-87, 0363-0495-95
Set ID 16625a43-22c1-4754-a7bd-ccc262e2dbd5
Category HUMAN OTC DRUG LABEL
Packager Walgreen Company
Generic Name
Product Class
Product Number
Application Number ANDA078336
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  • Active ingredient (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 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. (1-800-222-1222)

  • Directions

    adults and children 6 years and over

    one 10 mg tablet once daily; do not take more than one 10 mg tablet 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 between 20-25°C (68-77°F)
    •
    do not use if blister unit is broken or torn
  • Inactive ingredients

    corn starch, FD&C blue no. 1 aluminum lake, hypromellose, lactose monohydrate, magnesium stearate, polydextrose, polyethylene glycol, povidone, titanium dioxide, triacetin

  • Questions or comments?

    1-800-719-9260

  • Principal Display Panel

    ORIGINAL PRESCRIPTION STRENGTH

    Wal-Zyr™

    Compare to Zyrtec® active ingredient

    24 HOUR ALLERGY

    CETIRIZINE HYDROCHLORIDE TABLETS 10 mg / ANTIHISTAMINE

    24 HOUR

    TABLETS

    INDOOR & OUTDOOR ALLERGIES

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

    24 HOUR

    ACTUAL SIZE

    5 TABLETS 10 mg EACH

    4h2-94-wal-zyr.jpg
  • INGREDIENTS AND APPEARANCE
    WAL ZYR 
    cetirizine hydrochloride tablet, film coated
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-0495
    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
    STARCH, CORN (UNII: O8232NY3SJ)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    HYPROMELLOSES (UNII: 3NXW29V3WO)  
    LACTOSE MONOHYDRATE (UNII: EWQ57Q8I5X)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    POLYDEXTROSE (UNII: VH2XOU12IE)  
    POLYETHYLENE GLYCOL (UNII: 3WJQ0SDW1A)  
    POVIDONE (UNII: FZ989GH94E)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Product Characteristics
    ColorWHITEScoreno score
    ShapeOVALSize10mm
    FlavorImprint Code 4H2
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-0495-135 in 1 CARTON01/31/2008
    11 in 1 BLISTER PACK; Type 0: Not a Combination Product
    2NDC:0363-0495-061 in 1 CARTON11/06/2013
    270 in 1 BOTTLE; Type 0: Not a Combination Product
    3NDC:0363-0495-391 in 1 CARTON08/14/2008
    330 in 1 BOTTLE; Type 0: Not a Combination Product
    4NDC:0363-0495-471 in 1 CARTON05/02/2008
    4150 in 1 BOTTLE; Type 0: Not a Combination Product
    5NDC:0363-0495-6614 in 1 CARTON01/09/2008
    51 in 1 BLISTER PACK; Type 0: Not a Combination Product
    6NDC:0363-0495-721 in 1 CARTON01/27/200809/20/2015
    660 in 1 BOTTLE; Type 0: Not a Combination Product
    7NDC:0363-0495-751 in 1 CARTON01/27/2008
    790 in 1 BOTTLE; Type 0: Not a Combination Product
    8NDC:0363-0495-871 in 1 CARTON01/21/2010
    8300 in 1 BOTTLE; Type 0: Not a Combination Product
    9NDC:0363-0495-951 in 1 CARTON01/05/2009
    945 in 1 BOTTLE; Type 0: Not a Combination Product
    10NDC:0363-0495-581 in 1 CARTON08/08/2016
    1040 in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07833601/09/2008
    Labeler - Walgreen Company (008965063)
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