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 June 1, 2024

If you are a consumer or patient please visit this version.

View All Sections
  • 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 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)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!