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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:
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
PREA(P):
P
Sponsor:
Cumberland Pharmaceuticals, Inc
NNPS:
FALSE
Therapeutic Category:
Analgesic; Antipyretic
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