Answered By: Laurissa Gann
Last Updated: Sep 29, 2015     Views: 19439

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. http://pi.lilly.com/us/byetta-pi.pdf. 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.

 

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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"
    http://www.fda.gov/ohrms/dockets/dockets/05n0479/05N-0479-emc0004-04.pdf

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

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

    Laurissa
    by Laurissa Gann on Oct 13, 2015.

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