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How to Access FDA Approved PI Information

How to Access FDA Approved PI Information

Internet search engines are not likely to get you to the official Package Insert, with copy reviewed and approved against clear, scientific criteria by the FDA. A number of pages or entries into a search, marketing sites or offers of cheap Internet drugs will prevail.

Here’s how to get to the official version:

Go to

http://dailymed.nlm.nih.gov/dailymed/about.cfm

Type the name of the drug in the search box (if you don’t have a name handy, try “Metformin” and then pick a version; note that the tab “Patient Package Insert” is active on Metformin, so you can see what information is intended specifically for patients there.

The names of these drugs are used simply as examples of how to navigate Daily Med. As you will see, there is seldom only one official Package Insert on the website, offering further opportunities for confusion.

To see an example of a Medication Guide:

Go to http://dailymed.nlm.nih.gov/dailymed/about.cfm
Search Boniva® (Copyright R unnecessary for search)
Click on the “tab” labeled “Medication Guide”


To see an example of a Patient Package Insert:

Go to http://dailymed.nlm.nih.gov/dailymed/about.cfm
Search Viagra® (Copyright R unnecessary for search)
Click on the “tab” labeled “Patient Package Insert”