What must RX labeling indicate regarding the drug?

The requirement that prescription labeling must indicate "RX only" or similar warnings is crucial for distinguishing prescription medications from over-the-counter products. This designation serves to inform both healthcare professionals and patients that the drug requires a prescription for legal dispensing and is intended for use under a healthcare provider's supervision. Such labeling helps mitigate risks associated with self-medication, ensuring that patients receive guidance from a qualified professional regarding the appropriate use, potential side effects, and contraindications of the drug.

In contrast, the other options do not adequately reflect the necessary regulatory requirements for prescription labeling. For instance, indicating that a drug is available without a prescription is misleading for prescription medications, as this implies it can be obtained without professional oversight. Similarly, stating that labeling includes manufacturer details only disregards the comprehensive information expected on a label, which should also cover specific usage guidelines, warnings, and dosing information. Lastly, failing to include dosage information would not only be a regulatory violation but could also potentially endanger patients by providing them with insufficient guidance on how to properly take the medication. Thus, including "RX only" or similar warnings is essential for ensuring safe medication practices.