Quick Links: Skip to main page content
Skip to Search
Skip to Topics Menu
Skip to Common Links
U.S. Food & Drug Administration
Follow FDA
En Español
Search FDA
Home
Food
Drugs
Medical Devices
Radiation-Emitting Products
Vaccines, Blood & Biologics
Animal & Veterinary
Cosmetics
Tobacco Products
New Pediatric Labeling Information Database - Detail
FDA Home
Pediatrics
New Pediatric Labeling Information Database
Detail
-
Please note:
JavaScript must be enabled for this application to work properly.
Check your settings
if you are unsure if your JavaScript is enabled.
Pediatric Labeling Date:
01/28/2008
Trade Name:
Xyzal 0.5 mg/mL Oral Solution
Generic Name or Proper Name (*):
levocetirizine dihydrochloride
Indications Studied:
Relief of symptoms associated with seasonal and perennial allergic rhinitis (SAR and PAR) and treatment of uncomplicated skin manifestations of chronic idiopathic urticaria (CIU)
Label Changes Summary:
Dosing information provided Studies waived in children less than 6 months of age with PAR and CIU Waived in children less than 2 years of age with SAR New dosage form pediatric
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
UCB
NNPS:
TRUE'
Therapeutic Category:
Antihistamine
-
-