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Package Insert Audio

 

Synonym(s): Product Label, Prescribing Information, Prescription Drug Labeling

Drug prescribing information prepared by the drug manufacturer and approved by the 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.

See Related Term(s): Food and Drug Administration

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