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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:  11/20/2015
 
Trade Name:  Caldolor Injection
 
Generic Name or Proper Name (*):  ibuprofen
 
Indications Studied:  Management of mild to moderate pain and the management of moderate to severe pain as an adjunct to opioid analgesics, and for the reduction of fever in pediatric patients 6 months and older
 
Label Changes Summary:  *Expanded the indication down to pediatric patients 6 months and older; previously approved in adults *The effectiveness for the treatment of pain and fever has not been studied in pediatric patients less than 6 months. *Information on dosing, adverse reactions, and clinical trials *Postmarketing study
 
Product Labeling:  Labeling  Opens a new window
 
PREA(P):  P
 
Sponsor:  Cumberland Pharmaceuticals, Inc
 
NNPS:  FALSE
 
Therapeutic Category:  Analgesic; Antipyretic
 
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