Provide enough detail to facilitate correct use, achieve maximum benefit, and minimae harm, including a statement that identifies activities (such as driving or sunbathing) that the patient should avoid.

Write text that is unbiased in content and tone and scientifically accurate. The uses described should be consistent with FDA-approved labeling or otherwise permitted by FDA, or should appear in federally recognized drug compendia. Distinguish unlabeled from labeled use.

For drugs sold under a brand name, provide both brand and generic names, and include a pronunciation guide for each.

Describe the drug and its dosage form. Include indications and contraindications, specific directions for use, what to do if a dose is missed, and what to do in the event of an overdose or poisoning. 

Do not use abbreviations.

Indicate the intended type of benefit (for example, “cure”, “prevention”, “to help relieve symptoms”). Indicate how-and how soon- the patient should recognize the benefit and what to do if none is observed.

Give a balanced evaluation of risks and benefits.

List side effects, in order ot severity, such as “serious”, “most common,” and other similar type groupings, it may not be appropriate to provide sufficient detail for the patient to be able to monitor serious or common side effects. Provide guidance to consult the doctor or pharmacist, and indicate that all the side effects are listed.

List sufficiently specific and comprehensive information that includes the provision of all important risk information. Patients should be advised to be sure to inform the provider about all the medicines they are taking.

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