Answered By: Laurissa Gann
Last Updated: Oct 03, 2018     Views: 40658

AMA Style

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:

Sylatron (peginterferon alfa-2b) [package insert]. Whitehouse Station, NJ: Merck Sharp & Dohme Corp; 2011.

APA 6th Style

In APA 6th, 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):

  • Who is responsible for the content of the package insert?
  • When was it published?
  • What is the document called? You may include [Package insert] to help identify what the item is.
  • Where did it come from? The publisher and author of the package insert are the same, so use the author’s info in the publisher position.

For example:

Merck Sharp & Dohme Corp. (2011). Sylatron™ (peginterferon alfa-2b) [Package insert]. Whitehouse Station, NJ: Author.

For more information about citing drug package inserts, visit the APA Style Blog.

EndNote Formatting

In EndNote, you can manually create a package insert citation by going to References and then New Reference.  Choose Journal for the reference type.  Enter the year into the Year field. Enter the rest of 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.

 

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Comments (3)

  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.
  3. How would I cite a package insert with a revision date?

    The Farley Library at Wilkes University, PA has an example of a revision date in a citation for a package insert:
    Name of medicine [package insert on the Internet]. Place of publication: Manufacturer; Year of publication [dated cited]. Available from: URL

    More information: https://wilkes.libguides.com/c.php?g=191948&p=1266866
    by STLMD on Jul 28, 2018.

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