(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.