Label: CETIRIZINE HYDROCHLORIDE- cetirizine hydrochloride solution

  • NDC Code(s): 51672-2106-1, 51672-2106-4, 51672-2106-8
  • Packager: Taro Pharmaceuticals U.S.A., Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated 01/15

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)

    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
    • 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

    • use only with enclosed dosing cup
    • find right dose on chart below
    • mL = milliliter
    adults and children 6 years and over 5 mL or 10 mL once daily depending upon severity of symptoms; do not take more than 10 mL in 24 hours.
    adults 65 years and over 5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age 2.5 mL once daily. If needed, dose can be increased to a maximum of 5 mL once daily or 2.5 mL every 12 hours. Do not give more than 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

    • do not use if carton is opened or if imprinted safety seal is broken or missing
    • see bottom panel for lot number and expiration date
    • store between 20° to 25°C (68° to 77°F)
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  • Inactive ingredients

    bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

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  • Questions?

    Call 1-866-923-4914

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  • SPL UNCLASSIFIED SECTION

    Distributed by: Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

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  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    Compare to the
    active ingredient
    in Children's Zyrtec
    ®*

    NDC 51672-2106-8

    Children's
    Cetirizine
    Hydrochloride
    Oral Solution
    1 mg/mL ALLERGY

    Antihistamine

    Indoor & Outdoor Allergies

    SUGAR FREE

    24
    Hour

    Relief of:

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

    2 Yrs. & older

    Bubble Gum
    Flavor

    Dosing Cup Included

    4 FL OZ
    (120 mL)

    Principal Display Panel - 120 mL Bottle Carton
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  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:51672-2106
    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 1 mg  in 1 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 anhydrous (UNII: NVG71ZZ7P0)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color YELLOW (colorless to slightly yellow) Score     
    Shape Size
    Flavor BUBBLE GUM Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:51672-2106-8 1 in 1 CARTON
    1 120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2 NDC:51672-2106-1 1 in 1 CARTON
    2 240 mL in 1 BOTTLE; Type 0: Not a Combination Product
    3 NDC:51672-2106-4 1 in 1 CARTON
    3 60 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA201546 05/20/2011
    Labeler - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    Name Address ID/FEI Business Operations
    Taro Pharmaceutical Industries, Ltd. 600072078 MANUFACTURE(51672-2106)
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