Citation Guide: ICMJE - Package Inserts

Citing Medicine: The NLM Style Guide for Authors, Editors, and Publishers does not contain specific information about how to cite package insert. Please use the following format.

Drug name [package insert]. Place of publication: Manufacturer’s name; Year of publication.

Example
Albuterol [package insert]. West Roxbury, MA: Armstrong Pharmaceuticals, Inc.; 2007.