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New Pediatric Labeling Information Database - Detail
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Pediatrics
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
PREA(P):
P
Sponsor:
Schering
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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