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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:
03/03/2005
Trade Name:
Clarinex D 24 Hour Extended Release Tablets
Generic Name or Proper Name (*):
desloratadine/pseudoephedrine
Indications Studied:
Relief of nasal and non-nasal symptoms of seasonal allergic rhinitis, including nasal congestion, in patients 12 years of age and older
Label Changes Summary:
Two safety and effectiveness studies conducted in patients 12 years of age and older PK study Studies waived in children < 12 years of age New active ingredient; new dosing regimen
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Schering
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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