Package Insert
Audio
Synonym(s)
Drug Label, Prescribing Information, Prescription Drug Labeling, Product Label
Drug prescribing information prepared by the drug manufacturer and approved by the U.S. Food and Drug Administration (FDA). The package insert includes details and directions that health care providers need to prescribe a drug properly, including approved uses for the drug, contraindications, potential adverse reactions, available formulations and dosage, and how to administer the drug. The package insert is included with drug packaging and is used to develop any promotional or labeling materials.