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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:  02/01/2006
 
Trade Name:  Clarinex-D 12 Hour Extended Release Tablets
 
Generic Name or Proper Name (*):  desloratadine/pseudoephedrine
 
Indications Studied:  Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis in children 12 years of age and older
 
Label Changes Summary:  Approval based on two safety and effectiveness studies in patients down to 12 years of age Not an appropriate dosage form for use in pediatric patients below 12 years of age. Studies waived in children < 12 years of age New dosing regimen
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Schering
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine
 
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