Label: CETIRIZINE HYDROCHLORIDE solution

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

Drug Label Information

Updated March 22, 2019

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  • Active ingredient (in each 5 mL)

    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 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
    •
    find right dose on chart below
    •
    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
  • Other information

    •
    store between 20° to 25°C (68° to 77°F)
    •
    do not use if carton is opened, or if printed neckband is broken or missing
    •
    see bottom panel for lot number and expiration date
  • Inactive ingredients

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

  • Questions or comments?

    1-800-719-9260

  • HOW SUPPLIED

    Product: 50090-4173

    NDC: 50090-4173-0 118 mL in a BOTTLE / 1 in a CARTON

  • cetirizine hydrochloride

    Label Image
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:50090-4173(NDC:45802-974)
    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)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    SUCROSE (UNII: C151H8M554)  
    Product Characteristics
    ColorYELLOW (Pale Yellow) Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:50090-4173-01 in 1 CARTON03/07/2019
    1118 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09025404/15/2008
    Labeler - A-S Medication Solutions (830016429)
    Establishment
    NameAddressID/FEIBusiness Operations
    A-S Medication Solutions830016429RELABEL(50090-4173)
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