Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4087
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4087
Character Range: 1904078–1907176

4087                                      POTASSIUM CHLORIDE                                                                       A, E, H   When for oral use:
                                                                                                                                             (a) potassium is a mandatory component of potassium chloride;
                                                                                                                                             (b) the medicine requires the following warning statement on the medicine label:
                                                                                                                                             - (POTAS1) 'If you have kidney disease or are taking heart or blood pressure medicines - consult your doctor or pharmacist before use. Keep out of reach of children.'; and
                                                                                                                                             (c) except when the medicine is for use as oral rehydration therapy, the amount of potassium chloride per dosage unit must not be more than 550 mg.
                                                                                                                                             Medicines containing potassium chloride for use as oral rehydration therapy, are subject to the following conditions:
                                                                                                                                             (a) the medicine complies with the requirements specified in the British Pharmacopoeia, as in force or existing from time to time, for Oral Rehydration Salts;
                                                                                                                                             (b) the sodium, potassium and glucose content, and total osmolarity of the solution after it has been prepared according to the instructions on the packet are consistent with the criteria specified by the World Health Organisation (WHO) and the United Nations Children's Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation' 18 July 2001; and
                                                                                                                                             (c) the following warning statements are required on the medicine label:
                                                                                                                                             - (UOAD) 'Use only as directed'
                                                                                                                                             - (DIAR3) 'If diarrhoea persists, seek medical advice.'
                                                                                                                                             When for dental use, the concentration of potassium chloride in the medicine must not be more than 3.75%.