Q. How do I cite a drug package insert?

According to AMA style rules (3.13.6 Package Inserts), package inserts may be cited as follows:

1. Name of drug. Package insert. Manufacturer; *Year of publication.

• Risperdal (Risperidone). Package insert. Janssen Pharmaceutical; 2019.

2. Name of drug. Prescribing information. Manufacturer, *Year of publication. Access date. URL

• Demerol (Meperidine Hydrochloride Injection, USP). Prescribing information. Pfizer, 2024. Accessed August 14, 2025. https://www.pfizermedical.com/demerol 

*The year of publication refers to the latest revision of the package insert. If this information is not provided with the insert, it is usually available from Drugs@FDA: FDA-Approved Drugs.

EndNote

You can use EndNote to create a reference for a drug packet insert to be cited in a paper.

1. Go to References > Choose New Reference
2. Enter the complete citation (as outlined above) in the Title field. 
3. Click Save
4. Close (X) the Reference window