Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3963
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3963
Character Range: 1858642–1860346

3963                                      POLIGLUSAM DERIVED FROM ASPERGILLUS NIGER                                                A, E      When for oral use:
                                                                                                                                             (a) the maximum recommended daily dose of the medicine must not provide more than 2000 mg of Poliglusam derived from Aspergillus niger;
                                                                                                                                             (b) the following warning statement (or words to the same effect) is required on the medicine label:
                                                                                                                                             - (CHITO) 'Poliglusam should be taken at least one hour after any other medication as it may reduce the effect of other medication.'; and
                                                                                                                                             (c) if the medicine is a powdered dosage form, the following warning statement is also required on the medicine label:
                                                                                                                                             - (DNTPOW) 'Do not take powder alone. Mix with food or fluid.'
                                                                                                                                             When used as an excipient, Poliglusam derived from Aspergillus niger is only permitted for use in topical medicines for dermal application.