Label: BEST CHOICE CHILDRENS CETIRIZINE- cetirizine hydrochloride solution

  • NDC Code(s): 63941-088-08
  • Packager: Valu Merchandisers Company
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 12/12

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 teaspoonful)

    Cetirizine HCl 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
    • itchy, watery eyes
    • sneezing
    • 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

    • use only with enclosed dosing cup
    adults and children 6 years and over 1 teaspoonful (5 mL) or 2 teaspoonfuls (10 mL) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10 mL) in 24 hours.
    adults 65 years and older 1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
    children 2 to under 6 years of age 1/2 teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or 1/2 teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
    children under 2 years of age ask a doctor
    consumers with liver or kidney disease ask a doctor
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  • Other information

    • store between 20° to 25°C (68° to 77°F)
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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

    PROUDLY DISTRIBUTED BY:
    VALU MERCHANDISERS, CO.
    KANSAS CITY, MO 64111

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  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

    COMPARE TO THE ACTIVE
    INGREDIENT IN CHILDREN'S ZYTREC®*

    HEALTH
    Best Choice® Brand
    CARE

    Children's
    CETIRIZINE
    HYDROCHLORIDE
    ORAL SOLUTION
    1 mg/mL Antihistamine

    Indoor & Outdoor Allergies

    24 Hour
    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    Dosing Cup Included

    Grape Flavored
    Syrup

    2 Yrs. & older

    4 FL OZ
    (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    BEST CHOICE   CHILDRENS CETIRIZINE
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:63941-088
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    acetic acid (UNII: Q40Q9N063P)  
    glycerin (UNII: PDC6A3C0OX)  
    methylparaben (UNII: A2I8C7HI9T)  
    propylene glycol (UNII: 6DC9Q167V3)  
    propylparaben (UNII: Z8IX2SC1OH)  
    water (UNII: 059QF0KO0R)  
    sodium acetate (UNII: 4550K0SC9B)  
    sucrose (UNII: C151H8M554)  
    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:63941-088-08 1 in 1 CARTON
    1 118 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 - Valu Merchandisers Company (868703513)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries Ltd. 600072078 MANUFACTURE(63941-088)
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