Drug Labeling refers to the information submitted to the FDA by drug companies regarding drug listing information. This printed information accompanies a drug, including the label, wrapping, and package insert. Drug labeling is overseen by the FDA's Division of Drug Marketing, Advertising, and Communications. These regulations always apply to both prescription and over-the-counter drugs.

Labeling laws require that the statement of ingredients include all ingredients, and that the ingredients are referred to by their established names. In addition, clear instructions must be provided to health care practitioners for prescription drugs and to consumers for over-the-counter drugs. The label must also include any warnings to the consumer, such as: no driving for five hours after taking this medication.

The label must include instructions for correctly using the medicine, including the dosage and what to do if the patient misses a couple of doses. This description will also cover any special instructions such as taking the medicine with plenty of water or on a full stomach. The label will encourage discussing questions with a health professional and lastly, the label should warn of the danger associated with giving the drug to someone other than the patient its intended for.

Every so often, clear labeling fails and problems arise from the use of prescription or over the counter drugs. The FDA is constantly working to improve these deficiencies in the labeling process, and as these improvements are made, good health will subsequently follow.