Label: CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

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

Drug Label Information

Updated December 13, 2020

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  • Active ingredient (in each 5 mL teaspoonful)

    Cetirizine Hydrochloride USP 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.

  • 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 1/2 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

  • Other information

    store between 20° to 25° C (68° to 77°F)

  • Inactive ingredients

    banana flavor, glacial acetic acid, glycerin, grape flavor, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate, sucrose

  • Questions?

    call 248-449-9300

    Distributed by:
    C.D.M.A, Inc.©
    43157 W.Nine Mile
    Novi.MI 48376-0995
    www.qualitychoice.com
    Questions: 248-449-9300

  • PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)

    NDC 63868-865-04

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

    Children's

    Allergy
    Relief

    Indoor & Outdoor
    Allergies

    Cetirizine Hydrochloride
    Oral Solution, USP 1mg/mL
    Antihistamine

    For Relief of:
    Runny Nose | Sneezing
    Itchy, Watery Eyes |
    Itchy Nose or Throat

    2 yrs. & older

    Grape
    Flavor

    Dosing Cup
    Included

    4 FL OZ (120 mL)





    PACKAGE LABEL- PRINCIPAL DISPLAY PANEL 4 FL OZ (120 mL Bottle)
  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:63868-865
    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 (UNII: 4550K0SC9B)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (Colorless to Pale Yellow) Score    
    ShapeSize
    FlavorBANANA, GRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:63868-865-041 in 1 CARTON11/20/2014
    1120 mL in 1 BOTTLE; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09075011/20/2014
    Labeler - C.D.M.A., Inc. (011920774)
    Registrant - Aurohealth LLC (078728447)
    Establishment
    NameAddressID/FEIBusiness Operations
    Aurobindo Pharma Limited918917642MANUFACTURE(63868-865)
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