Precautions and Information for patients/patient counseling information- Product Labeling

Precautions:
Actions required to make sure a medicine is properly and safely used are included under Precautions if not covered in other sections of the PI (for example, under Warnings, Dosage and Administration,Indications and Usage, or Contraindications).Precautions for health care professionals are covered separately from precautions for patients. For example, health care professionals might be instructed to ensure that certain preexisting medical
conditions are treated prior to using the medicine because of the risk of the medicine exacerbating those conditions, or to test the levels of certain enzymes in the patient that might affect the activity of the medicine.
This section also may include information for the prescriber concerning certain laboratory tests that may be necessary or helpful to the practitioner to ensure the medication is being used safely or to help predict when possible adverse reactions might occur.
[Note: The Information for Patients subsection, within the Precautions section under the old labeling rules, has been deleted under the new PI labeling format. It may still appear in older labels, but not in the newer labels. That section has been replaced by the Patient Counseling Information section (see
below).]

Information for patients/patient counseling information:

This section explains to health care professionals the information about the medicine that they should discuss with their patients. Such information might include precautions about operating machinery when using the medicine, or instructions on when to take the medicine relative to mealtimes.Note that this section may have different titles and locations within the product label according to when the medicine and/or its labeling was approved. Whether in the newer or older format, however, the same types of information are provided.
• Information for Patients is found in PIs for older medicines. You will find it as a subsection under the Precautions section near the middle of the PI.
• Patient Counseling Information, on the other hand, is a separate section at the very end of the PIs for newer medicines.
If a medication has information designed specifically for patients (Patient Package Insert or Medication Guides), that information would be contained in a separate document that may be printed at the end of the PI, or provided separately. That kind of labeling is not always necessary or required, so not all medications will have such a document