Label: CHILDRENS CETIRIZINE HYDROCHLORIDE SUGAR FREE GRAPE- cetirizine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 1, 2022

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  • 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
    •
    itchy, watery eyes
    •
    sneezing
    •
    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 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 older

    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
  • Other information

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

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

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

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

    Relabeled by: Proficient Rx LP
    Thousand Oaks, CA 91320

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

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

    NDC 71205-705-72

    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

    Grape Flavor

    Dosing Cup Included

    4 FL OZ
    (120 mL)

    71205-705-72
  • INGREDIENTS AND APPEARANCE
    CHILDRENS CETIRIZINE HYDROCHLORIDE  SUGAR FREE GRAPE
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:71205-705(NDC:51672-2102)
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride1 mg  in 1 mL
    Inactive Ingredients
    Ingredient NameStrength
    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    Score    
    ShapeSize
    FlavorGRAPE, BANANAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:71205-705-721 in 1 CARTON10/13/2022
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09018209/08/2011
    Labeler - Proficient Rx LP (079196022)
    Establishment
    NameAddressID/FEIBusiness Operations
    Proficient Rx LP079196022RELABEL(71205-705)
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