What does “adequate directions for use” mean for over-the-counter drugs?

“Adequate directions for use” refers to the requirement that instructions provided for over-the-counter (OTC) drugs must be understandable to the average consumer. This means that the language used should be straightforward, avoiding medical jargon, and should clearly convey how to properly and safely use the product. This clarity helps ensure that consumers can read and follow the instructions without needing additional guidance from healthcare professionals.

The emphasis is on empowering laypersons to understand the product's purpose, dosage, administration, and any relevant warnings or contraindications. Clear and accessible instructions help prevent misuse or accidents, which is critical in promoting public health and safety with OTC medications.