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U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

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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  Opens a new window
Sponsor:  UCB
Therapeutic Category:  Antihistamine