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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:  05/25/2007
 
Trade Name:  Xyzal Tablets 5 mg
 
Generic Name or Proper Name (*):  levocetirizine
 
Indications Studied:  Relief of symptoms associated with seasonal allergic rhinitis and perennial allergic rhinitis in adults and children 6 years of age or older, and for the treatment of the uncomplicated skin manifestations of chronic idiopathic urticaria in adults and children 6 years of age or older
 
Label Changes Summary:  Summary is pending
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  UCB
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine
 
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