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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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