Label: CVS PHARMACY CHILDRENS ALLERGY RELIEF- cetirizine hydrochloride solution

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

Drug Label Information

Updated February 12, 2013

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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
    • itchy, watery eyes
    • sneezing
    • 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
    adults and children 6 years and over1 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 older1 teaspoonful (5 mL) once daily; do not take more than 1 teaspoonful (5 mL) in 24 hours.
    children 2 to under 6 years of age½ teaspoonful (2.5 mL) once daily. If needed, dose can be increased to a maximum of 1 teaspoonful (5 mL) once daily or ½ teaspoonful (2.5 mL) every 12 hours. Do not give more than 1 teaspoonful (5 mL) in 24 hours.
    children under 2 years of ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

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

    artificial grape flavor, glacial acetic acid, glycerin, methylparaben, natural and artificial banana flavor, propylene glycol, propylparaben, purified water, sodium acetate (anhydrous), sucralose

  • Questions?

    Call 1-866-923-4914

  • SPL UNCLASSIFIED SECTION

    Distributed by: CVS Pharmacy, Inc.
    One CVS Drive, Woonsocket, RI 02895

  • PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton

    CVS
    pharmacy®

    NDC 59779-276-04

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

    Original Prescription Strength

    24
    HOUR

    INDOOR & OUTDOOR
    ALLERGIES

    NEW!

    Children's
    ALLERGY
    RELIEF

    CETIRIZINE HYDROCHLORIDE
    ORAL SOLUTION 1mg/mL ANTIHISTAMINE

    24 hour relief of:

    • Runny nose
    • Itchy, watery eyes
    • Sneezing
    • Itchy throat
      & nose

    Sugar free
    Dye free
    2 yrs. & older
    Dosing cup included

    2 FL OZ
    (60 mL)

    Grape Flavor

    PRINCIPAL DISPLAY PANEL - 60 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CVS PHARMACY   CHILDRENS ALLERGY RELIEF
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:59779-276
    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)  
    water (UNII: 059QF0KO0R)  
    sucralose (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    ColorYELLOW (colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPE (sugar free) Imprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:59779-276-041 in 1 CARTON
    160 mL in 1 BOTTLE
    2NDC:59779-276-011 in 1 CARTON
    2240 mL in 1 BOTTLE
    3NDC:59779-276-081 in 1 CARTON
    3120 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09018209/08/2011
    Labeler - CVS Pharmacy (062312574)
    Registrant - Taro Pharmaceuticals U.S.A., Inc. (145186370)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceutical Industries Ltd.600072078MANUFACTURE(59779-276)
    Establishment
    NameAddressID/FEIBusiness Operations
    Taro Pharmaceticals Inc.206263295MANUFACTURE(59779-276)
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