Label: CHILDRENS XYZAL ALLERGY- levocetirizine dihydrochloride solution

  • NDC Code(s): 41167-3530-1, 41167-3533-0, 41167-3535-0, 41167-3535-1
  • Packager: Chattem, Inc.
  • Category: HUMAN OTC DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: New Drug Application

Drug Label Information

Updated February 16, 2024

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  • SPL UNCLASSIFIED SECTION

    Children’s Xyzal® Allergy 24HR

    Drug Facts

  • Active ingredient (in each 5 mL)

  • Purpose

    Levocetirizine dihydrochloride 2.5 mg……..............................................................................................Antihistamine

  • Uses  

    temporarily relieves these symptoms due to hay fever or other respiratory allergies:

    ■ runny nose  ■ sneezing  ■ itchy, watery eyes  ■ itching of the nose or throat 

  • Warnings

    Do not use  

    ■ if you have kidney disease  

    ■ if you have ever had an allergic reaction to this product or any of its ingredients or to an antihistamine containing cetirizine

    Ask a doctor before use if you have

    ■ ever had trouble urinating or emptying your bladder

    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  

    ■ you have trouble urinating or emptying your bladder

    ■ 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 65 years of age and older■ ask a doctor
    adults and children 12-64 years of age ■ take 5 mL or 10 mL once daily in the evening depending upon severity of symptoms
    ■ do not take more than 10 mL in 24 hours
    children 6-11 years of age■ take 5 mL once daily in the evening
    ■ do not take more than 5 mL in 24 hours
    children 2-5 years of age■ take 2.5 mL once daily in the evening
    ■ do not take more than 2.5 mL in 24 hours
    children under 2 years of age■ do not use
    consumers with kidney disease■ do not use
    Note: mL=milliliters
  • Other information

    ■ each 5 mL contains: sodium 3 mg

    ■ store between 20° and 25°C (68° and 77°F)

    ■ safety sealed: do not use if carton was opened or if printed foil inner seal on bottle is torn or missing

  • Inactive ingredients

    flavor, glacial acetic acid, glycerin, maltitol solution, methylparaben, propylparaben, purified water, saccharin sodium, sodium acetate trihydrate

  • Questions or comments?

    call 1-866-844-2798

  • PRINCIPAL DISPLAY PANEL

    Children’s Xyzal
    Allergy 24HR
    Liquid
    Grape Flavor

    PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Grape Flavor

  • PRINCIPAL DISPLAY PANEL

    Children’s Xyzal
    Allergy 24HR
    Liquid
    Tutti Frutti Flavor

    PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Tutti Frutti Flavor

  • PRINCIPAL DISPLAY PANEL

    Children’s Xyzal
    Allergy 24HR
    Liquid
    Bubblegum Flavor

    PRINCIPAL DISPLAY PANEL Children’s Xyzal Allergy 24HR Liquid Bubblegum Flavor

  • INGREDIENTS AND APPEARANCE
    CHILDRENS XYZAL ALLERGY 
    levocetirizine dihydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3535
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorGRAPEImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-3535-01 in 1 CARTON02/01/2023
    1148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    2NDC:41167-3535-11 in 1 CARTON04/01/2023
    2296 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20909002/01/2023
    CHILDRENS XYZAL ALLERGY 
    levocetirizine dihydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3530
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorTUTTI FRUTTIImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-3530-11 in 1 CARTON02/01/2023
    1148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20909002/01/2023
    CHILDRENS XYZAL ALLERGY 
    levocetirizine dihydrochloride solution
    Product Information
    Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3533
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    LEVOCETIRIZINE DIHYDROCHLORIDE (UNII: SOD6A38AGA) (LEVOCETIRIZINE - UNII:6U5EA9RT2O) LEVOCETIRIZINE DIHYDROCHLORIDE2.5 mg  in 5 mL
    Inactive Ingredients
    Ingredient NameStrength
    ACETIC ACID (UNII: Q40Q9N063P)  
    GLYCERIN (UNII: PDC6A3C0OX)  
    MALTITOL (UNII: D65DG142WK)  
    METHYLPARABEN (UNII: A2I8C7HI9T)  
    PROPYLPARABEN (UNII: Z8IX2SC1OH)  
    WATER (UNII: 059QF0KO0R)  
    SACCHARIN SODIUM (UNII: SB8ZUX40TY)  
    SODIUM ACETATE (UNII: 4550K0SC9B)  
    Product Characteristics
    ColorwhiteScore    
    ShapeSize
    FlavorBUBBLE GUMImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:41167-3533-01 in 1 CARTON01/04/2024
    1148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20909001/04/2024
    Labeler - Chattem, Inc. (003336013)
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