FDA Label for Childrens Xyzal Allergy

View Indications, Usage & Precautions

Childrens Xyzal Allergy Product Label

The following document was submitted to the FDA by the labeler of this product Chattem, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.

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

     


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