If known, include a statement concerning the safety of use in the presence of other conditions and during pregnancy or breast-feeding. Direct affected patients to discuss their condition with health care providers. If the safety of use during pregnancy or breast-feeding has not been established, say so.

State whether safety and efficacy have been established in pediatric, geriatric, and other special populations. Patients should be encouraged to discuss with their health care providers any recommendation for dosage adjustment.

Illustrate information with diagrams when appropriate. Label the diagram components (for example, device parts) if they are not obvious. The words on the label should be prominently placed thereon with such terms as to render them likely to be read and understood by the ordinary individual under customary conditions of purchase and use.

Include the following:

A statement that the product is to be used only by the person for whom it was prescribed.

Storage information.

A completeness disclaimer advising the patient to discuss this issue with the health care provider.

The publisher of the leaflet and the date the leaflet was developed to revised.

Sources of in-depth information and answers to questions, and 

Other relevant general statements.

The patient should be advised about risks of developing dependence on, or tolerance to, the medication.

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