A Medication Guide or other patient labeling may be required for certain medicines. This printed document contains FDA-approved information that may be included at the end of the PI, but must be made available separately.
A Medication Guide or other patient labeling may provide:
• Certain information that is necessary to prevent serious side effects.
• Information about a known serious side effect with a medicine to help patients to make an informed decision about whether the benefits of taking the medicine outweigh the risks.
• Directions for the use of a product that are essential to its effectiveness.
Refer this site: http://www.fda.gov/Drugs/DrugSafety/ucm085729.htm
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