Label: CHILDRENS ZYRTEC ALLERGY- cetirizine hydrochloride syrup

  • NDC Code(s): 50580-721-05
  • Packager: Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated October 11, 2018

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

  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • Active ingredient (in each 5 mL)

    Cetirizine HCl 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

    • use only with enclosed dosing cup
    • find right dose on chart below
    • mL = milliliter
    adults and children 6 years and over5 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 over5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age2.5 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 ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • do not use if carton is opened or if carton tape or bottle wrap imprinted "SAFETY SEAL®" is broken or missing
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

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

  • Questions?

    call 1-800-343-7805 (toll-free) or 215-273-8755 (collect).

  • PRINCIPAL DISPLAY PANEL

    NDC 50580-721-05

    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

    Bubble Gum
    Syrup

    Dye-Free • Sugar-Free

    4 fl oz (118 ml)

    Dosing Cup Included

    Principal Display Panel
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ZYRTEC ALLERGY 
    cetirizine hydrochloride syrup
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50580-721
    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
    anhydrous citric acid (UNII: XF417D3PSL)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorWHITE (Clear, Colorless) Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50580-721-051 in 1 CARTON07/13/2015
    1118 mL in 1 BOTTLE, PLASTIC; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA02215501/20/2009
    Labeler - Johnson & Johnson Consumer Inc., McNeil Consumer Healthcare Division (878046358)