Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2187
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2187
Character Range: 1042475–1044111

2187                                      FENNEL OIL                                                 A, E, H   Methyl chavicol is a mandatory component of fennel oil.
                                                                                                               When the concentration of methyl chavicol in the medicine is more than 5%, the nominal capacity of the container must be no more than 25mL, a restricted flow insert must be fitted on the container, and the following warning statement is required on the label:
                                                                                                               - (CHILD) 'Keep out of reach of children (or words to that effect).'
                                                                                                               The maximum daily dose must provide no more than 150 mg of fennel oil.
                                                                                                               When used in oral medicines, the following warning statements are required on the label:
                                                                                                               - (CHILD3) 'Use in children under 12 years is not recommended.'
                                                                                                               - (PREGNT2) 'Do not use if pregnant or likely to become pregnant (or words to that effect).'
                                                                                                               - (BREASF) 'Do not use while breastfeeding.'