Label: CETIRIZINE HYDROCHLORIDE solution

  • NDC Code(s): 70677-1236-1
  • Packager: STRATEGIC SOURCING SERVICES LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated February 6, 2024

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  • SPL UNCLASSIFIED SECTION

    Drug Facts

  • 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 useif 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 haveliver or kidney disease. Your doctor should determine if you need a different dose.

    Ask a doctor or pharmacist before use if you aretaking 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 ifan 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 over5 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 over5 mL once daily; do not take more than 5 mL in 24 hours.
    children 2 to under 6 years of age2.5 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 ageask a doctor
    consumers with liver or kidney diseaseask a doctor
  • Other information

    • do not use if carton is opened or if imprinted safety seal is broken or missing
    • see bottom panel for lot number and expiration date
    • 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 833-358-6431Monday to Friday 9:00am to 7:00pm EST

  • SPL UNCLASSIFIED SECTION

    Distributed by:McKesson Corp.,
    via Strategic Sourcing Services LLC.
    Memphis, TN 38141

  • PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton

    NDC 70677-1236-1

    COMPARE TO THE
    ACTIVE INGREDIENT
    IN CHILDREN'S ZYRTEC ®*

    Foster & Thrive™

    Children's
    All Day
    Allergy

    Cetirizine Hydrochloride
    Oral Solution
    1 mg/1 mL
    ANTIHISTAMINE Allergy

    Indoor & Outdoor Allergies
    24 hour relief of:

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

    Sugar Free

    Ages 2 years & older
    Dye Free
    GRAPE FLAVOR
    DOSING CUP ENCLOSED

    4 FL OZ (120 mL)

    PRINCIPAL DISPLAY PANEL - 120 mL Bottle Carton
  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70677-1236
    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
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70677-1236-11 in 1 CARTON02/02/2024
    1120 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA09018202/02/2024
    Labeler - STRATEGIC SOURCING SERVICES LLC (116956644)
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