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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:
06/21/2004
Trade Name:
Codeprex Extended-Release Suspension
Generic Name or Proper Name (*):
chlorpheniramine; codeine
Indications Studied:
Temporary relief of cough associated with the common cold or inhaled irritants; temporary relief of symptoms of hay fever, other upper respiratory allergies, or allergic rhinitis in children 6 years of age and older OTC
Label Changes Summary:
Approval and age range based on monograph for antitussives and antihistamine No clinical studies submitted Studies in children < 6 years of age deferred New dosage form; new dosing regimen
Product Labeling:
Labeling
PREA(P):
P
Sponsor:
Celltech Pharmaceuticals
NNPS:
FALSE'
Therapeutic Category:
Antihistamine
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