Label: CETIRIZINE liquid

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

Drug Label Information

Updated February 15, 2011

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

  • Active ingredient

    Cetirizine HCl 5mg

  • Keep Out of Reach of Children

  • PURPOSE

  • 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 a 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.

    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 (5ml) or 2 teaspoonfuls (10ml) once daily depending upon severity of symptoms; do not take more than 2 teaspoonfuls (10ml) in 24 hours.

    Adults 65 years and over: 1 teaspoonful (5mo) once daily; do not take more than 1 teaspoonful (5ml) in 24 hours.

    Children 2 to under 6 years of age:

    1/2 teaspoonful (2.5ml) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5mo) once daily or 1/2 teaspoonful (2.5ml) every 12 hours. Do not give more than 1 teaspoonful (5ml) 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 printed neckband is broken or missing.

    Questions or comments?

    Call 1-800-719-9260

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

    Dosing cup should be washed and left to air dry after each use.

  • Inactive ingredients

    acetic acid, artificial grape flavor, glycerin, methylparaben, natural banana flavor, propylene glycol, propylparaben, sodium acetate, sucrose, water

    Distributed by:

    AmerisourceBergen

    Valley Forge, PA 19482-0959

    Repackaged by:

    Rebel Distributors Corp

    Thousand Oaks, CA 91320

  • Package/Label Principal Display Panel

    Cetirizine HCl 1mg/ml

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE 
    cetirizine liquid
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:21695-878(NDC:24385-188)
    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
    ACETIC ACID (UNII: Q40Q9N063P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SUCROSE (UNII: C151H8M554)  
    WATER (UNII: 059QF0KO0R)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:21695-878-04120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA07839806/17/2008
    Labeler - Rebel Distributors Corp (118802834)
    Establishment
    NameAddressID/FEIBusiness Operations
    Rebel Distributors Corp118802834RELABEL, REPACK