Label: DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE- cetirizine hydrochloride solution

  • Category: HUMAN OTC DRUG LABEL

Drug Label Information

Updated November 17, 2016

If you are a healthcare professional or from the pharmaceutical industry please visit this version.

  • SPL UNCLASSIFIED SECTION

    Grape Flavor

    5 mg/5 mL

    For Hospital Use Only

    Drug Facts

    Close
  • Active ingredient (in each 5 mL)

    Cetirizine HCl 5 mg

    Close
  • Purpose

    Antihistamine

    Close
  • 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
    Close
  • 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)

    Close
  • Directions

    • Use as directed per healthcare professional.
    • 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
    Close
  • Other information

    • store between 20° to 25°C (68° to 77°F)
    • See individual label or shipper for lot number and expiration date.
    Close
  • Inactive ingredients

    anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

    Close
  • SPL UNCLASSIFIED SECTION

    Dye Free, Gluten Free, Sugar Free

    Close
  • How Supplied

    NDC 68094-004-62
    5 mL per unit dose cup
    Thirty (30) cups per shipper

    Close
  • SPL UNCLASSIFIED SECTION

    Distributed By
    Perrigo Company
    Allegan, MI 49010

    Packaged By
    Precision Dose, Inc.
    South Beloit, IL 61080

    LI1060 Rev. 05/16

    Close
  • PRINCIPAL DISPLAY PANEL - 5 mL Cup Label

    NDC 68094-004-59
    PrecisionDose ™

    Children's CETIRIZINE HCl
    Oral Solution
    5 mg/5 mL
    DYE
    FREE

    Pkg: Precision Dose, Inc., S. Beloit, IL 61080

    PRINCIPAL DISPLAY PANEL - 5 mL Cup Label
    Close
  • INGREDIENTS AND APPEARANCE
    DYE FREE CHILDRENS CETIRIZINE HYDROCHOLRIDE 
    cetirizine hydrochloride solution
    Product Information
    Product Type HUMAN OTC DRUG Item Code (Source) NDC:68094-004(NDC:0113-0503)
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Cetirizine Hydrochloride (UNII: 64O047KTOA) (Cetirizine - UNII:YO7261ME24) Cetirizine Hydrochloride 5 mg  in 5 mL
    Inactive Ingredients
    Ingredient Name Strength
    anhydrous citric acid (UNII: XF417D3PSL)  
    propylene glycol (UNII: 6DC9Q167V3)  
    water (UNII: 059QF0KO0R)  
    sodium benzoate (UNII: OJ245FE5EU)  
    sorbitol (UNII: 506T60A25R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color      Score     
    Shape Size
    Flavor GRAPE Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:68094-004-62 3 in 1 CASE 10/26/2016
    1 10 in 1 TRAY
    1 NDC:68094-004-59 5 mL in 1 CUP, UNIT-DOSE; Type 0: Not a Combination Product
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    ANDA ANDA204226 10/26/2016
    Labeler - Precision Dose, Inc. (035886746)
    Close