Labelling should include at least the following:
(a) The name of the product;
(b) A list of the active ingredients (using INNs if applicable) showing the amount of each present in a dosage unit, and a statement of the net contents of the container, e.g. number of dosage units, weight or volume;
(c) The batch number assigned by the manufacturer;
(d) The expiry date in an uncoded form;
(e) Any special storage conditions or handling precautions that may be necessary;
(f) Directions for use, and any warnings or precautions that may be necessary;
(g) The name and address of the manufacturer, company or person responsible for placing the product on the market;
(h) The names of any excipients known to be a safety concern for some patients, e.g. gluten, metabisulfite, parabens, ethanol, or tartrazine.
The labelled storage conditions should be achievable in practice in the distribution network.
For containers of less than or equal to 10 ml capacity that are marketed in an outer pack such as a carton, and the outer pack bears all the required information, the immediate container need only contain items (b), (c), (d), (g) - or a logo that unambiguously identifies the company - and the name of the dosage form or the route of administration