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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:  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  Opens a new window
 
PREA(P):  P
 
Sponsor:  Celltech Pharmaceuticals
 
NNPS:  FALSE'
 
Therapeutic Category:  Antihistamine
 
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