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Childrens Xyzal Allergy

Dosage form: solution
Ingredients: LEVOCETIRIZINE DIHYDROCHLORIDE 0.5mg in 1mL
Labeler: Chattem, Inc.
NDC Code: 41167-3530

Childrens Xyzal Allergy

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
(Note: Age ranges are bolded in the draft container labeling for tablet bottle)

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
xyzal
Allergy 24HR
2.5 mg/ 5 mL
5 fl. oz.
(148 mL)
Tutti Frutti Flavor

CHILDRENS XYZAL ALLERGY 
levocetirizine dihydrochloride solution
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:41167-3530
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
LEVOCETIRIZINE DIHYDROCHLORIDE (LEVOCETIRIZINE) LEVOCETIRIZINE DIHYDROCHLORIDE0.5 mg  in 1 mL
Inactive Ingredients
Ingredient NameStrength
ACETIC ACID 
GLYCERIN 
MALTITOL 
METHYLPARABEN 
PROPYLPARABEN 
WATER 
SACCHARIN SODIUM 
SODIUM ACETATE 
Product Characteristics
ColorWHITEScore    
ShapeSize
FlavorTUTTI FRUTTIImprint Code
Contains    
Packaging
#Item CodePackage Description
1NDC:41167-3530-11 BOTTLE in 1 CARTON
1148 mL in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
NDANDA20909002/16/2017
Labeler - Chattem, Inc. (003336013)

 
Chattem, Inc.

Medically reviewed on Feb 21, 2017

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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