FDA
Injectable ibuprofen approved for use in children as young as 3 months
May 17, 2023

FDA has expanded the approval of Caldolor (ibuprofen for injection) for the treatment of pain and fever in children ages 3 to 6 months. Previously the drug was approved for use in children 6 months of age and older. According to the manufacturer, Caldolor is the only injectable non-opioid product approved to treat pain in infants.
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