How do I cite a drug package insert in NLM citation format?
Citing Medicine: The NLM Style Guide for Authors, Editors, and Publishers does not contain specific information about how to cite drug package insert. We recommend you use the following format. 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]. Place of publication : Publisher; Year of publication/revision.
For example:
- Risperdal (risperidone) [package insert].Titusville, NJ: Janssen Pharmaceutical Companies; 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.