HIV/AIDS Glossary

Package Insert

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

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.

Related Term(s): Food and Drug Administration

Search the Glossary

What's this?


AIDSinfo Glossary App

Download Glossary