Product label

The product label is developed during the formal process of review and approval by regulatory agencies of any medicine or medical product. There are specific regulations concerning what must be included in a medicine label regarding its content, and how it works, as well as its proper administration and handling, its side effects, and its proven effectiveness and safety. The content and
presentation of any medicine’s specific labeling—originally drafted and submitted by the manufacturer—are reviewed and approved by regulatory agencies, which may require changes or additions to the label before approving the use of the medicine.

In the U.S., the complete label of a prescription medicine is made up of several documents that are approved and required by FDA—some professionally oriented and some intended for patients and consumers. The first and most comprehensive of these documents is always the professional Prescribing Information. Others may include Patient Counseling Information and a patient-oriented Medication Guide.