Product information for the consumer

Product labels and package inserts should be understandable to the consumer or patient. The package information should include all necessary information on the proper use of the product.

The following elements of information will usually suffice:

• name of the product
• quantitative list of active ingredient(s)
• dosage form
• indications

• dosage (if appropriate, specified for children and the elderly)
• mode of administration
• duration of use
• major adverse effects, if any
• overdosage information
• contraindications, warnings, precautions and major drug interactions
• use during pregnancy and lactation

• expiry date
• lot number
• holder of the marketing authorization.

Identification of the active ingredient(s) by the Latin botanical name, in addition to the common name in the language of preference of the national regulatory authority, is recommended.

Sometimes not all information that is ideally required may be available, so drug regulatory authorities should determine their minimal requirements.

Promotion

Advertisements and other promotional material directed to health personnel and the general public should be fully consistent with the approved package information.