Label: CHILDRENS XYZAL ALLERGY- levocetirizine dihydrochloride solution

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

Drug Label Information

Updated August 18, 2022

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

  • SPL UNCLASSIFIED SECTION

    Children’s Xyzal Allergy 24HR Oral Solution

    Drug Facts

  • Active ingredient (in each 5 mL)

    Levocetirizine dihydrochloride 2.5 mg

  • Purpose

    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 1-800-633-1610

  • PRINCIPAL DISPLAY PANEL

    NDC 41167-3530-1
    Children’s
    XYZAL
    Allergy 24HR
    5 fl. oz.
    (148 mL)
    Tutti Frutti Flavor

    PRINCIPAL DISPLAY PANEL
NDC 41167-3530-1
Children’s
XYZAL
Allergy 24HR
5 fl. oz.
(148 mL)
Tutti Frutti Flavor

         

  • INGREDIENTS AND APPEARANCE
    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 CARTON02/16/2017
    1148 mL in 1 BOTTLE; Type 0: Not a Combination Product
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    NDANDA20909002/16/2017
    Labeler - Chattem, Inc. (003336013)