In the United States, indications for prescription drugs are approved by the FDA. Indications are included in the Indications and Usage section of the Prescribing Information. The primary role of this section of labeling is to enable health care practitioners to readily identify appropriate therapies for patients by clearly communicating the drug’s approved indication(s). The Indications and Usage section states the disease or condition, or manifestation or symptoms thereof, for which the drug is approved, as well as whether the drug is indicated for the treatment, prevention, mitigation, cure, relief, or diagnosis of that disease or condition. Additionally, the Indications and Usage section should contain the approved age groups as well as other information necessary to describe appropriate use (e.g., identifying the indicated patient/disease subgroups, stating if adjunctive therapy is required).