Label: WAL-ZYR  CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution 

  • NDC Code(s): 0363-2088-02, 0363-2088-05, 0363-2088-08
  • Packager: Walgreen Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

NOTE: Most over the counter (OTC) are not reviewed and approved by the FDA. However, they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Drug Label Information

Updated 01/13

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

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

    Cetirizine Hydrochloride 5 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
    • 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).

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  • Directions

    • medicine should be dispensed directly into mouth using the enclosed pre-filled vial(s).
    adults and children 6 years and over 1 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 over 1 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 age ask a doctor
    Consumer with liver or kidney disease ask a doctor
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  • 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
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  • Inactive ingredients

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

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

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

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  • 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
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  • INGREDIENTS AND APPEARANCE
    WAL-ZYR   CETIRIZINE HYDROCHLORIDE
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:0363-2088
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cetirizine Hydrochloride (Cetirizine) Cetirizine Hydrochloride 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    acetic acid  
    glycerin  
    methylparaben  
    propylene glycol  
    propylparaben  
    water  
    sodium acetate anhydrous  
    sucrose  
    Product Characteristics
    Color YELLOW (colorless to slightly yellow) Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0363-2088-05 10 in 1 CARTON
    1 1 in 1 POUCH
    1 5 mL in 1 VIAL, SINGLE-DOSE
    2 NDC:0363-2088-08 1 in 1 CARTON
    2 120 mL in 1 BOTTLE
    3 NDC:0363-2088-02 1 in 1 CARTON
    3 240 mL in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA090182 04/22/2008
    Labeler - Walgreen Company (008965063)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(0363-2088)
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