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The TGA Labelling Orders require medicine labels to include 'warning statements' where these apply to the medicines, including any advisory statements specified in the instrument made under subsection 3(5A) of the ('the Act'), as in force from time to time.The RASML is registered on the Federal Register of Legislative Instruments under subsection 3(5A) of the Act, as the Medicines Advisory Statements Specification ('the Specification'). The advisory statements required by the RASML are designed to inform consumers about specific risks related to the use of medicines that have been identified during development and evaluation of new medicines, or subsequent pharmacovigilance activities, testing, adverse event reports or from other scientific or clinical information.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).Medicines that are not included in the SUSMP are referred to as ‘unscheduled’ medicines (freely available from general retail outlets).As is always the case for the RASML, more restrictive statements will also fulfil these requirements (e.g.where a medicine is only labelled for adults and children 12 years and older, the single statement' will suffice).
In the context of self-medication, the medicine label is the primary source of information for the consumer; so the label must contain the directions and advisory statements that are needed for safe and effective use of these medicines.
This includes but is not limited to: Cetirazine (Zyrtec)and Dipenhydramine (Benadryl).
Research which illustrates the dangers of OTC Allergy / Cold Medications *It is assumed that allergies or colds being treated are not chronic, or severe and that medications will be used short term as directed by a physician.
The TGA proposes to take this opportunity to make some editorial changes, in order to harmonise the entries for each of these medicines as far as possible, as well as to reduce the total number of entries, and to more clearly specify which substances are affected by these entries.
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