• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

New Pediatric Labeling Information Database - Detail

  • Print
  • Share
  • E-mail
-
 
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
 
-
-