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18-Aug-2020 16:02

The RASML sets out the advisory statements that are required to be included on the labels of specified medicines. The RASML permits the wording of the actual statements that are included on medicine labels to differ from the wording set out in the RASML, as long as the intent is the same.

The current version of the Specification is the Medicines Advisory Statements Specification 2017 (MASS 2017). First-generation antihistamines are available in a variety of doses and formulations.

Medicines that are unscheduled or included in Schedules 2 or 3 of the SUSMP are collectively referred to either as ‘non-prescription medicines’, ‘over-the-counter medicines’ or 'OTC medicines'.

Consumers rely on information from their health practitioner, pharmacist and medicine label in order to use medicines safely and effectively.


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For historical reasons, paediatric-only antihistamine substances other than cetirizine and levocetirizine are not currently subject to a RASML requirement for a sedation warning.The majority of medicines that are included in the SUSMP fall under one of the following classifications: Schedule 2 - Pharmacy Medicine (available from a pharmacy without a prescription); Schedule 3 - Pharmacist Only Medicine (available from a pharmacist without a prescription); or Schedule 4 (Prescription Only Medicine).