Article 54
The following particulars shall appear on the outer packaging of medicinal products or, where there is no outer packaging, on the immediate packaging: (a) the name of the medicinal product followed by the common name where the product contains only one active substance and if its name is an invented name; where a medicinal product is available in several pharmaceutical forms and/or several strengths, the pharmaceutical form and/or the strength (baby, child or adult as appropriate) must be included in the name of the medicinal product; (b) a statement of the active substances expressed qualitatively and quantitatively per dosage unit or according to the form of administration for a given volume or weight, using their common names; (c) the pharmaceutical form and the contents by weight, by volume or by number of doses of the product; (d) a list of those excipients known to have a recognized action or effect and included in the guidelines published pursuant to Article 65. However, if the product is injectable, or a topical or eye preparation, all excipients must be stated; (e) the method and, if necessary, the route of administration; (f) a special warning that the medicinal product must be stored out of reach of children; (g) a special warning, if this is necessary for the medicinal product; (h) the expiry date in clear terms (month/year); (i) special storage precautions, if any; (j) special precautions for disposal of unused medicinal products or waste materials from medicinal products, if appropriate; (k) the name and address of the holder of the authorization for placing the medicinal product on the market; (l) the number of the authorization for placing the medicinal product on the market; (m) the manufacturer's batch number; (n) in the case of self-medication, instructions on the use of the medicinal products.