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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
Sponsor:  Celltech Pharmaceuticals
Therapeutic Category:  Antihistamine