Childrens Xyzal Allergy

Childrens Xyzal Allergy
SPL v22
SPL
SPL Set ID a33f2704-d350-428b-b467-91f4775ce17f
Route
ORAL
Published
Effective Date 2026-01-21
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Levocetirizine (2.5 mg)
Inactive Ingredients
Acetic Acid Glycerin Maltitol Methylparaben Propylparaben Water Saccharin Sodium Sodium Acetate

Identifiers & Packaging

Pill Appearance
Color: white
Marketing Status
NDA Active Since 2024-01-04 Until 2025-11-01

Description

Children’s Xyzal ®   Allergy 24HR Drug Facts

Purpose

Antihistamine


Medication Information

Purpose

Antihistamine

Description

Children’s Xyzal ®   Allergy 24HR Drug Facts

Use

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

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

Active

Levocetirizine dihydrochloride 2.5 mg

Section 42229-5

Children’s Xyzal ®   Allergy 24HR

Drug Facts

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
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

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

If Pregnant Or Breast

■ if breast-feeding: not recommended

■ if pregnant: ask a health professional before use

Questions Or Comments?

call 1-8 66 - 844 - 2798

Principal Display Panel

Children’s Xyzal

Allergy 24HR

Liquid

Grape Flavor

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.

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).

Ask A Doctor Before Use If You Have

ever had trouble urinating or emptying your bladder


Structured Label Content

Use

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

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

Active

Levocetirizine dihydrochloride 2.5 mg

Section 42229-5 (42229-5)

Children’s Xyzal ®   Allergy 24HR

Drug Facts

Purpose

Antihistamine

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
Do Not Use (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

Other Information (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 (Inactive ingredients)

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

If Pregnant Or Breast (If pregnant or breast)

■ if breast-feeding: not recommended

■ if pregnant: ask a health professional before use

Questions Or Comments? (Questions or comments?)

call 1-8 66 - 844 - 2798

Principal Display Panel (PRINCIPAL DISPLAY PANEL)

Children’s Xyzal

Allergy 24HR

Liquid

Grape Flavor

When Using This Product (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 (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.

Keep Out of Reach of Children. (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).

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

ever had trouble urinating or emptying your bladder


Advanced Ingredient Data


Raw Label Data

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