Label: CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

  • NDC Code(s): 69230-316-11
  • Packager: Camber Consumer Care Inc
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated March 27, 2024

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  • Active ingredient

    (in each 5 mL)
    Cetirizine Hydrochloride USP 5mg


  • 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 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 over
    		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

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

    anhydrous citric acid, flavors, non crystallizing sorbitol solution, propylene glycol, purified water, sodium benzoate and sucralose.

  • Questions?

    call 1-888-588-1418
                                                  
    Distributed by:
    Camber Consumer Care, Inc.
    Piscataway, NJ 08854, USA.


  • PRINCIPAL DISPLAY PANEL

    Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-container label


    cetirizinehcloscontlabel


    Cetirizine Hydrochloride Oral Solution USP, 1 mg/1 mL-carton label


    cetirizinehcloscarton

  • INGREDIENTS AND APPEARANCE
    CHILDRENS ALLERGY RELIEF  
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69230-316
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    SORBITOL (UNII: 506T60A25R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Coloryellow (Colorless to Yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:69230-316-111 in 1 CARTON03/13/2019
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21062203/13/2019
    Labeler - Camber Consumer Care Inc (079539968)
    Establishment
    NameAddressID/FEIBusiness Operations
    Hetero Labs Limited Unit III676162024manufacture(69230-316)
    Establishment
    NameAddressID/FEIBusiness Operations
    Annora Pharma Private Limited650980746manufacture(69230-316)
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