Label: CHILDRENS ALL DAY ALLERGY SUGAR FREE GRAPE- cetirizine hydrochloride suspension

  • NDC Code(s): 55319-104-07, 55319-104-08
  • Packager: FAMILY WELLNESS
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated October 30, 2019

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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
    • 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

    • 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)
  • 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: MIDWOOD BRANDS, LLC
    500 VOLVO PARKWAY, CHESAPEAKE, VA 23320

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton

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

    FAMILY
    wellnss™

    Children's
    ALLERGY

    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

    2 yrs. & older
    Dye-Free • Sugar-Free

    Grape Flavored

    Dosing Cup Included

    4 fl oz (118 mL)

    100% SATISFACTION
    OR YOUR MONEY BACK
    GUARANTEED

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALL DAY ALLERGY   SUGAR FREE GRAPE
    cetirizine hydrochloride suspension
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55319-104
    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
    ColorYELLOW (Colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPE, BANANAImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:55319-104-081 in 1 CARTON03/28/2018
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:55319-104-071 in 1 CARTON10/03/2019
    2118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09018204/22/2008
    Labeler - FAMILY WELLNESS (024472631)
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