(1998; 88 pages)
8.5 Label requirements
It is recommended that the following is printed on the product label in the official language(s) used by the countries or areas:
(a) name of product;
(b) name and quantity (in dry weight when relevant) of active ingredient(s);
(c) dosage form;
(d) directions for use including indications, dosage, mode of administration, duration of use, age group limitations, and use during pregnancy and lactation;
(e) warning statements and relevant contraindications, adverse effects, if any, and overdose information when relevant;
(f) batch number;
(g) expiry date;
(h) storage conditions;
(i) name and address of manufacturers and/or importers; and
(j) registration or notification (listing) number.
The scientific name of active ingredient(s), in addition to the common name in the language of preference of the national regulatory authority, should be used.
The label and package insert should be “user-friendly”. Easy and understandable information should be provided.
The drug regulatory authority may provide to industry directions on labelling and on allowable indications and claims.