Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4489
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4489
Character Range: 2101729–2105293

4489                                      SENNA FRUIT ALEXANDRIAN POWDER                                                           A, H      When for oral or sublingual use, Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Senna fruit alexandrian powder.
                                                                                                                                             When used in oral medicines, if the maximum recommended daily dose contains more than 10 mg of hydroxyanthracene derivatives the medicine requires the following warning statements on the medicine label:
                                                                                                                                             - (CHILD3) 'Use in children under 12 years is not recommended';
                                                                                                                                             - (LAX2) 'Prolonged use may cause serious bowel problems'; and
                                                                                                                                             - (LAX3) 'Do not use when abdominal pain, nausea or vomiting are present, or if you develop diarrhoea. If you are pregnant or breast feeding, seek the advice of a healthcare professional before taking this product' (or words to that effect).
                                                                                                                                             When promoted or marketed as a laxative, the medicine requires the following warning statement on the medicine label:
                                                                                                                                             - (LAX1) 'Drink plenty of water' (or words to that effect).
                                                                                                                                             When not promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:
                                                                                                                                             - (LAX5) 'This product contains [name of the herb(s) or the chemical component(s)]'; and
                                                                                                                                             - (LAX4) 'This product may have laxative effect'.
                                                                                                                                             When used in oral medicines, if the maximum recommended daily dose contains less than 10 mg of hydroxyanthracene derivatives and is promoted or marketed as laxative, the medicine requires the following warning statements on the medicine label:
                                                                                                                                             - (CHILD3) 'Use in children under 12 years is not recommended';
                                                                                                                                             - (LAX1) 'Drink plenty of water' (or words to that effect); and
                                                                                                                                             - (LAX2) 'Prolonged use may cause serious bowel problems'.