What must be included in the labeling of over-the-counter medications?

Over-the-counter (OTC) medications must have specific elements included in their labeling to ensure the safety and efficacy of the product for consumers. The correct answer encompasses key components that are necessary for users to understand what the medication is, how it should be used, and the potential risks involved.

Including active ingredients provides consumers with clear information on what is in the product, allowing them to identify the medication and its mechanisms. The purpose of the medication indicates what the product is intended to treat or alleviate, which is critical for consumers to make informed choices. Furthermore, detailing the uses of the medication informs consumers of the specific conditions or symptoms for which the product is deemed effective.

Warnings are crucial as they provide necessary safety information, highlighting possible side effects, contraindications, or interactions with other substances. Directions on how to use the medication help users administer it correctly, ensuring proper dosing and enhancing the likelihood of therapeutic effectiveness.

The other options do not cover the essential labeling requirements for OTC medications comprehensively. For example, dosage forms and expiration dates alone provide insufficient information for safe and effective use. A list of clinical studies, while useful in some contexts, would not be practical for consumer labeling, as it could overwhelm users with technical data rather than providing the needed practical information