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U.S. Department of Health and Human Services

About FDA

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Patient Labeling and Risk Communication (includes Medication Guides)


FDA-Approved Patient Labeling


  • Patient Package Inserts.  For some prescription medicines, FDA approves special patient materials to instruct patients about the safe use of the product. These materials may be given to patients by their health care provider or pharmacist, and are considered part of FDA-regulated product labeling.
  • Medication Guides.  FDA-approved patient information for selected prescription drugs that pose a serious and significant public health concern.


Useful Private Sector Written Prescription Drug Information for Patients


National Telephone Surveys of Prescription Medicine Information Received by Consumers


Since 1982, FDA has conducted eight national telephone surveys to determine the percentage of consumers who receive oral and written information about their prescription medicine from their doctor’s office or pharmacy.