Answered By: Laurissa Gann
Last Updated: Sep 29, 2015     Views: 22659

In AMA style, 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):

Name of Medicine [package insert]. Place of publication : Publisher; Year of publication.

For example:

Byetta(R) [package insert]. Amylin Pharmaceuticals, Inc., San Diego, CA; 2007.

If the information was obtained online rather than from the physical paper insert, the elements should include a URL and an accessed date.  For example:

Byetta(R) [package insert]. Amylin Pharmaceuticals, Inc., San Diego, CA; October 2007. Accessed Mar 18, 2008.

In EndNote, you can manually create a package insert citation by going to References and then New Reference.  Choose "webpage" for the reference type, even if you got the information from a paper insert.  Enter all of the citation information in the "Title" field within the EndNote citation you are creating. If there is a url attached to the citation, enter the url and accessed date. Save the citation upon closing, and then use it normally as any other EndNote reference.



Comments (2)

  1. Thank you very much for this. It was helpful. How should one cite an Drug-label that is found at the FDA website?

    How should I cite the following "New Drug Approval" document, which is the same as the package insert (at that time). The drug is Marinol, the manufacturer was (Unimed Pharmaceuticals, apparently a subsidary of Solvay"

    Thank you very much.
    by BrettMD on Oct 13, 2015.
  2. Hi Brett,

    I would cite this the same way you cite a package insert.

    by Laurissa Gann on Oct 13, 2015.

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