Labelling excipient composition

Labelling should state clearly the excipient composition of the medicine so that predictable harmful effects can be avoided, especially in very young patients. For the formulator, the choice of excipients should be guided by a thorough risk assessment of the excipients, the route of administration and the patient susceptibility. It is highly recommended to refer to manuals such as authorities guidelines, pharmacopoeias, a handbook of excipients and the latest literature available. 

For preparations presented in single-dose-units it is important to indicate the composition per dosage unit, as well as the number of units supplied. As a consequence it will sometimes be necessary to calculate the quantity of excipients per unit from the amount used for the whole batch (i.e. fillers in capsules). When only the quantities of ingredients for the whole batch are indicated in the label, there is the risk that other caregivers will interpret the composition falsely. For the same reason, according to the EMA... 

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