What is included in the labeling of a drug?

The labeling of a drug encompasses the label itself, which is affixed to the container, as well as any written materials that accompany the drug product. This comprehensive definition aligns with regulatory standards, which stipulate that labeling must provide essential information about the medication. This could include indications for use, dosing instructions, and safety information, ensuring that patients and healthcare providers have access to necessary details for safe and effective use.

Given this context, the choice that specifies both the label and any written materials on the container accurately reflects the legal requirements and best practices for drug labeling. It ensures that users receive complete information, which is crucial for understanding how to use the medication properly and safely. Other responses fail to capture the full scope of what constitutes labeling, either limiting it to just the label or just the accompanying written material, which does not comply with the regulatory definition.