What key information must labeling of prescription medications include according to the FDA?

The correct choice emphasizes the essential elements that must be included in the labeling of prescription medications according to FDA regulations. This includes critical details such as the drug name, which identifies the specific medication, the dosage form, which indicates how the drug is administered (such as tablet, capsule, liquid, etc.), the route of administration (like oral, topical, or injectable), and instructions for use that guide the patient on how to take the medication safely and effectively.

These components are vital for ensuring that the patient understands how to properly use the medication. Insufficient or unclear labeling can lead to improper usage, which may result in ineffective treatment or adverse effects. Thus, adhering to these guidelines protects public health by promoting safe medication practices.

While other information, such as a patient's diagnosis, the prescribing physician’s contact details, or the cost of the medication, may be relevant in various contexts, they are not mandated by the FDA for the labeling of prescription medications. These details may be found in other documentation or communication between healthcare providers and patients, but they do not fall under the key labeling requirements set forth by the FDA.