In AMA style(login required), the elements of a citation for a package insert are as follows (note that you may wish to include a trademark symbol if appropriate for the drug name). To be clear, the year of publication refers to the latest available revision of the drug package insert, which can be found on the FDA website:
Print source:
Name of medicine. Package insert [or Prescribing information, etc.]. Manufacturer; Year of Publication.
For example:
- Risperdal (risperidone). Package insert. Janssen Pharmaceutical; 2019.
FDA website:
Manufacturer. Name of medicine [package insert]. U.S. Food and Drug Administration website. URL. Revised [date]. Accessed [date].
For example:
- Janssen Pharmaceutical Companies. Risperdal (risperidone) [package insert]. U.S. Food and Drug Administration website.www.accessdata.fda.gov/drugsatfda_docs/label/2019/020272s082,020588s070,021444s056lbl.pdf. Revised January 2019. Accessed May 20, 2019.
EndNote Formatting
In EndNote, you can manually create a package insert citation by going to References and then New Reference. Choose Journal Article for the reference type. Enter the citation into the Title field within the EndNote citation you are creating. Save the citation upon closing, and then use it normally as any other EndNote reference.
