Label: CETIRIZINE HYDROLORIDE ALLERGY- cetirizine hydroloride solution

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

Drug Label Information

Updated October 3, 2011

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  • Drug Facts

  • ACTIVE INGREDIENT

    Active Ingredient (in each 5 mL teaspoonful)

    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 DOCTOR


    Ask a doctor before use if you have liver or kidney disease. Your doctor should determine if you need a different dose.
  • ASK DOCTOR/PHARMACIST


    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


    Stop use and ask 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 toll-free number 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 over
    		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
    		½ 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 age
    		ask a doctor
    consumers with liver or kidney disease
    		ask a doctor                              
  • Other information

    Store between 20 to 25ºC (68 to 77ºF) or store refrigerated, 2 to 8ºC (36 to 46ºF)

  • Inactive ingredients


    artificial grape flavor, glacial acetic acid, glycerin, methylparaben, purified water, propylene glycol, propylparaben, sodium acetate, and sucrose
  • Questions or comments?


    call toll-free 1-800-818-4555 weekdays

    Dosing Cup Included

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

    Do not use if carton is opened, or if seal on bottle is broken or missing.

    Dist. by:      Caraco Pharmaceutical Laboratories, Ltd.

                  Detroit, Michigan 48202

    Mfg. by: SUN Pharmaceutical Industries, Inc.

                  Bryan, Ohio 43506


    6028L01                                          Iss: 09/11
  • Principal Display Panel


    NDC 57664-263-31
     
    2 years & older

    Children’s

    Cetirizine

    Hydrochloride

    1mg / mL  Oral Solution, USP

    antihistamine

    ALLERGY

    Indoor and Outdoor Allergies

    24 Hour Relief of

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

    Dosing Cup Included

    Do not use if carton is opened, or if seal on bottle is broken or missing.

    2 years and older

    Grape Syrup


    4 fl. oz. (120 mL)                    
     
    image

     
     
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROLORIDE ALLERGY 
    cetirizine hydroloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:57664-263
    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)  
    WATER (UNII: 059QF0KO0R)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (Colorless to slightly yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:57664-263-31120 mL in 1 BOTTLE
    2NDC:57664-263-34470 mL in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09132712/01/2011
    Labeler - Caraco Pharmaceutical Laboratories, Ltd (146974886)
    Registrant - Sun Pharmaceutical Industries Inc. (621283733)
    Establishment
    NameAddressID/FEIBusiness Operations
    Sun Pharmaceutical Industries Inc.621283733MANUFACTURE, ANALYSIS
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