Label: CETIRIZINE HYDROCHLORIDE solution

  • NDC Code(s): 70752-103-06, 70752-104-06
  • Packager: QUAGEN PHARMACEUTICALS LLC
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: Abbreviated New Drug Application

Drug Label Information

Updated May 18, 2023

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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.
    • Side effects occur: You may report side effects to FDA at 1-800-FDA-1088.

    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 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)
    • Protect from light
    • do not use if carton is opened or if carton tape or bottle wrap imprinted "SEALED FOR YOUR PROTECTION" is broken or missing
    • see bottom panel for lot number and expiration date
  • Inactive ingredients

    Bubble Gum Syrup: anhydrous citric acid, artificial bubble gum flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

    Grape Syrup: anhydrous citric acid, artificial grape flavor, propylene glycol, purified water, sodium benzoate, sorbitol solution, sucralose

  • Questions?

    Call 1-888-344-9603 (toll-free)

  • SPL UNCLASSIFIED SECTION

    Manufactured by:
    Quagen Pharmaceuticals LLC
    West Caldwell, NJ 07006

    51001 & 51002
    Rev. 10/18

  • PRINCIPAL DISPLAY PANEL - Grape Flavor - Container Label

    Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Label

  • PRINCIPAL DISPLAY PANEL - Grape Flavor-Carton Label

    Cetirizine Hydrochloride Oral Solution, 1 mgmL - Grape Flavor - Container Label

  • INGREDIENTS AND APPEARANCE
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70752-103
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70752-103-061 in 1 CARTON10/15/2022
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21226610/15/2022
    CETIRIZINE HYDROCHLORIDE 
    cetirizine hydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70752-104
    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
    ANHYDROUS CITRIC ACID (UNII: XF417D3PSL)  
    PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
    WATER (UNII: 059QF0KO0R)  
    SODIUM BENZOATE (UNII: OJ245FE5EU)  
    SORBITOL (UNII: 506T60A25R)  
    SUCRALOSE (UNII: 96K6UQ3ZD4)  
    Product Characteristics
    Color    Score    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:70752-104-061 in 1 CARTON10/15/2022
    1118 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    ANDAANDA21226610/15/2022
    Labeler - QUAGEN PHARMACEUTICALS LLC (073645339)
    Registrant - QUAGEN PHARMACEUTICALS LLC (073645339)
    Establishment
    NameAddressID/FEIBusiness Operations
    QUAGEN PHARMACEUTICALS LLC080281331manufacture(70752-103, 70752-104) , pack(70752-103, 70752-104)
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