What must prescription drug labeling include?

The requirement for prescription drug labeling to include adequate information for use is fundamental to ensuring patient safety and effective medication management. This information encompasses dosage instructions, administration routes, indications for use, and any necessary precautions the patient needs to take while using the medication. Such details empower patients to use their medications correctly and enhance the effectiveness of therapy while minimizing risks associated with misuse.

In contrast, while providing complete instructions for pharmacists, warnings for all potential side effects, and manufacturer’s information can be important, none of these components alone are sufficient to fulfill the core requirement of labeling. The principle behind requiring adequate information for use is that it directly impacts the patient's understanding and compliance with the medication prescribed, thereby prioritizing their health outcomes.