Label: CETIRIZINE HYDROCHLORIDE solution

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

Drug Label Information

Updated July 11, 2011

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  • Active ingredient (in each 5 mL teaspoonful)

    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 breastfeeding: 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
    • 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 older: 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

    bubble gum artificial flavor, glacial acetic acid, glycerin, methylparaben, propylene glycol, propylparaben, purified water, sodium acetate anhydrous, sucralose

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Dosing cup should be washed and left to air dry after each use. Do not use if carton is opened or if imprinted safety seal is torn or missing.

    Dist. by:
    Taro Pharmaceuticals U.S.A., Inc.
    Hawthorne, NY 10532

  • PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label

    NDC 51672-2106-8

    Children's
    Cetirizine
    Hydrochloride
    Oral Solution

    1 mg/mL
    Antihistamine

    ALLERGY
    Indoor & Outdoor Allergies

    2 Yrs.
    & older

    Dye Free
    Sugar Free
    Bubble Gum Flavor

    24
    Hour

    Relief of:

    • Sneezing
    • Runny Nose
    • Itchy, Watery Eyes
    • Itchy Throat or Nose

    4 FL OZ (118 mL)

    PRINCIPAL DISPLAY PANEL - 118 mL Bottle Label
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:52549-2106
    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
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:52549-2106-81 in 1 CARTON
    1118 mL in 1 BOTTLE
    2NDC:52549-2106-11 in 1 CARTON
    2237 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA20154605/20/2011
    Labeler - Taro Pharmaceutical Industries, Ltd. (600072078)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries, Ltd.600072078MANUFACTURE
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