Table 2.

The minimum requirements recommended on the package label of advertised drugs in Nigeria by the National Agency for Food and Drug Administration and Control (NAFDAC).

Product name should be brand and generic where applicable. The generic name must be in similar characters with the brand name. Manufacturer’s address. Batch number. Date of manufacture and best before/expiry date. Dosage regimen on the package and leaflet insert. Indications, frequency, route and conditions of administration. Quantitative listing of all the active ingredients per unit dose. Adequate warnings where necessary. Where a brand name is used, there must be the generic name which should be conspicuous in character, written directly under the brand name. Any drug product which is labelled in a foreign language should not be considered for registration unless an English translation is included on the label and package insert (where applicable). Information on indication carried on packages and leaflet insert of imported drug product should not differ from that in other countries and in particular the country of origin of the product.