Label: WAL-ZYR CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated January 22, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL pre-filled vial)

    Cetirizine Hydrochloride 5 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

    • medicine should be dispensed directly into mouth using the enclosed pre-filled vial(s).
    adults and children 6 years and over1 pre-filled (5 mL) or 2 pre-filled vials (10 mL) once daily depending upon severity of symptoms; do not take more than 2 pre-filled vials (10 mL) in 24 hours.
    adults 65 years and over1 pre-filled vial (5 mL) once daily; do not take more than 1 pre-filled vial (5 mL) in 24 hours.
    children under 6 years of ageask a doctor
    Consumer with liver or kidney diseaseask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • Do not use if pouch is torn or damaged. Do not use if twist-off cap is removed or separated from vial.
    • See side panel for lot number and expiration date
  • Inactive ingredients

    artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucrose.

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

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

  • PRINCIPAL DISPLAY PANEL - 10 Vial Carton

    Well at
    Walgreens

    WALGREENS PHARMACIST RECOMMENDEDǂ

    NDC 0363-2088-05

    NEW
    children's
    Wal-Zyr™

    Cetirizine Hydrochloride
    Oral Solution
    1 mg/mL / Antihistamine

    Allergy

    ● Alcohol free ● Gluten free
    ● 6 years & older

    Relieves:

    ● Sneezing ● Runny nose
    ● Itchy, watery eyes
    ● Itchy throat or nose

    INDOOR &
    OUTDOOR
    ALLERGIES

    24 HOUR
    SYMPTOM
    RELIEF

    DYE
    FREE

    GRAPE FLAVOR

    10
    PRE-FILLED INDIVIDUAL VIALS

    Compare to Children's Zyrtec®
    active ingredientǂǂ

    0.17 FL OZ (5 mL) EACH

    PRINCIPAL DISPLAY PANEL - 10 Vial Carton
  • INGREDIENTS AND APPEARANCE
    WAL-ZYR   CETIRIZINE HYDROCHLORIDE
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0363-2088
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    acetic acid (UNII: Q40Q9N063P)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium acetate anhydrous (UNII: NVG71ZZ7P0)  
    sucrose (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0363-2088-0510 in 1 CARTON
    11 in 1 POUCH
    15 mL in 1 VIAL, SINGLE-DOSE
    2NDC:0363-2088-081 in 1 CARTON
    2120 mL in 1 BOTTLE
    3NDC:0363-2088-021 in 1 CARTON
    3240 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09018204/22/2008
    Labeler - Walgreen Company (008965063)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(0363-2088)
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