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For products that haven’t received FDA approval + are only available via Emergency Use Authorization, a manufacturer insert will not be available. However, the FDA does require a “Fact Sheet” that is similar to an insert. These documents are evolving as more information is made available about the product. To find a fact sheet, use the previous method with the product plus “fact sheet .gov” and look through the search results for the most recent update.
If a product is sold over-the-counter (more on this later), the FDA might not have a manufacturer insert available. However, the National Institutes of Health has a database called “Daily Med” that provides insert-like information. Let’s look at Miralax as an example:
Using the search method discussed in the previous lesson, here are the search results for Miralax. If you click on the first link, it’ll take you to the FDA-approved labeling that you would see on the physical product (see below). This is not the “insert.”
The second link is not a .gov link and might contain outdated information. The third link will bring you to the FDA’s drug approval package. This will include product labeling (like the first link) as well as any reviews submitted to the FDA. You can read these, however they might be photocopied and not easily digested information. However the fourth link is NIH’s Daily Med database and will be the most user-friendly way to read the Miralax insert-like information (see below).
Most over-the-counter (OTC) products have not been evaluated by the FDA. Because of this, you can also search the product name or active ingredient with the following keywords:
This will paint a better picture on recent investigations or alerts to the product you are researching and provide more information to make an informed decision on accepting, delaying, or declining a medical product.