Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3579
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3579
Character Range: 1679715–1681668

3579                                      OMEGA-3-ACID ETHYL ESTERS 90                                                                  A         Only for use in oral medicines.
                                                                                                                                                  The maximum recommended daily dose of the medicine must not provide more than:
                                                                                                                                                  a) 4000 mg of omega-3-acid ethyl esters 90; and
                                                                                                                                                  b) 3750 mg EPA, DHA and DPA combined, when used alone or in combination with other sources of omega-3 fatty acids.
                                                                                                                                                  The following warning statements (or words to the same effect) are required on the medicine label:
                                                                                                                                                  - (ACOAG) 'Individuals taking anticoagulants should seek medical advice before taking this product.'
                                                                                                                                                  - (FOOD) 'To be taken with food.'
                                                                                                                                                  - (PREG) 'Not recommended for use during pregnancy or lactation.'
                                                                                                                                                  - (CHILD3) 'Use in children under 12 years is not recommended.'