CHILDRENS XYZAL ALLERGY- levocetirizine dihydrochloride solution 
Chattem, Inc.

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Childrens Xyzal Allergy

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

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)

Revised: 2/2024
Document Id: 2b84cde3-8f1f-41a6-9869-2282246a614e
Set id: a33f2704-d350-428b-b467-91f4775ce17f
Version: 13
Effective Time: 20240216
 
Chattem, Inc.