Drug labeling refers to all of the printed information that accompanies a drug, including the label, the wrapping and the package insert. Drug labeling is regulated by the Food and Drug Administration's Division of Drug Marketing, Advertising, and Communications. These regulations apply to prescription drugs, over-the-counter (nonprescription) drugs, and dietary supplements.

The Food and Drug Administration (FDA) requires that drug labeling be balanced and not misleading. The label must be scientifically accurate and provide clear instruction to health care practitioners for prescription drugs and to consumers for over-the-counter drugs and supplements. Labeling regulations require that the statement of ingredients must include all ingredients, in the order in which they are used in the drug. These ingredients must also be identified by their established name.

In evaluating prescription drug labels, the FDA looks at the overall usefulness of the information that accompanies the drug. The name of...