What is NOT included in the labeling requirements for adequate directions for use?

The labeling requirements for adequate directions for use primarily focus on guiding both healthcare professionals and patients on how to use a medication safely and effectively. This includes providing clear instructions on the quantity or dosage of the drug for its intended use, specifying the route or method of administration (such as oral, topical, or intravenous), and indicating the duration of administration to ensure that the medication is taken for an appropriate period to achieve optimal results.

Patient's medical history is not part of these labeling requirements. It is pertinent to individual patient care but does not typically appear on medication labels. Instead, healthcare providers use the patient's medical history to make individualized treatment decisions, potentially influencing the appropriateness or dosage of medications prescribed. However, this information is not necessary for the standard labeling of the product intended for broad use, hence why it is not included in the labeling requirements for adequate directions for use.