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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.
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.
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Office of Drug Safety
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Acrobat Reader.
FDA/Center for Drug Evaluation and Research
Last Updated: December 1, 2006
Originator: OTCOM/ODS
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