Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1234
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1234
Character Range: 597537–602914

1234                                      CASSIA FISTULA                                                                                   A, E, H   Hydroxyanthracene glycosides calculated as sennoside B is a mandatory component of Cassia fistula when the route of administration is oral.
                                                                                                                                                     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'.
                                                                                                                                                     When Cassia fistula is for use as an excipient:
                                                                                                                                                     (a) the plant part must be fruit; and
                                                                                                                                                     (b) must only be included in medicines when in combination with other permitted ingredients as a:
                                                                                                                                                     (i) flavour proprietary excipient formulation when the plant preparation is an extract; and/or
                                                                                                                                                     (ii) fragrance proprietary excipient formulation when the plant preparation is an essential oil.
                                                                                                                                                     The total concentration of flavour proprietary excipient formulations containing Cassia fistula must not be more than 5% of the total medicine.
                                                                                                                                                     The total concentration of fragrance proprietary excipient formulations containing Cassia fistula must not be more than 1% of the total medicine.