Label: CHILDRENS ZYRTEC- cetirizine hydrochloride syrup

  • NDC Code(s): 50580-730-04, 50580-730-09, 50580-730-15
  • Packager: McNeil Consumer Healthcare Div McNeil-PPC, Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: 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 10/09

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
    • 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
    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 over 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 ½ 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)
    • do not use if carton is opened; or if bottle wrap or foil inner seal printed with "Safety Seal®" is broken or missing
    • see bottom panel for lot number and expiration date
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  • Inactive ingredients

    anhydrous citric acid, flavors, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

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  • Questions?

    call 1-800-343-7805

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  • PRINCIPAL DISPLAY PANEL

    NDC 50580-730-04

    Children's
    ZYRTEC®
    ALLERGY

    Cetirizine HCl
    1 mg/mL oral solution
    antihistamine

    Indoor & Outdoor Allergies

    24
    hour
    Relief of
    •Sneezing
    •Runny Nose
    •Itchy, Watery Eyes
    •Itchy Throat or Nose

    2 yrs.
    & older

    Grape
    Syrup

    Dye-Free • Sugar-Free

    4 FL OZ (118 mL)
    Dosing Cup Included

    Principal Display Panel - 118 mL Carton
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  • INGREDIENTS AND APPEARANCE
    CHILDRENS ZYRTEC 
    cetirizine hydrochloride syrup
    Product Information
    Product Type HUMAN OTC DRUG LABEL Item Code (Source) NDC:50580-730
    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
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:50580-730-04 1 in 1 CARTON
    1 118 mL in 1 BOTTLE, PLASTIC
    2 NDC:50580-730-09 2 in 1 PACKAGE, COMBINATION
    2 118 mL in 1 BOTTLE, PLASTIC
    3 NDC:50580-730-15 12 in 1 CARTON
    3 15 mL in 1 BOTTLE, PLASTIC
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    NDA NDA022155 06/01/2009
    Labeler - McNeil Consumer Healthcare Div McNeil-PPC, Inc (878046358)
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