Final answer:
The minimum required information for labels on noncontrolled prescriptions includes critical details like the drug name, dosage, and prescribing practitioner. These requirements are part of the FDA's regulations ensuring that OTC drugs provide necessary information for safe use, adhering strictly to approved indications for advertising.
Step-by-step explanation:
The minimum required information for noncontrolled prescription labeling typically includes the drug name, strength, dosage, administration route, the total quantity of the drug provided, the name and address of the dispensing pharmacy, the serial number of the prescription, the date of the prescription or its filling, the name of the prescribing practitioner, and the name of the patient. In the context of the FDA's regulation of nonprescription drug products, an over-the-counter (OTC) drug must include the drug's purpose, specific indications, usage directions, warnings (including what to avoid), and inactive ingredients. Advertising for these drugs must be limited to the indications approved by the FDA and must provide a fair balance between the benefits and risks of the drug.