Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_4561
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 4561
Character Range: 2150580–2152884

4561                                      SODIUM BICARBONATE                                                                       A, E      When used as an active ingredient, the medicine may only be for oral rehydration salts in powdered and effervescent tablet dosage forms.
                                                                                                                                             Medicines containing sodium bicarbonate 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 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 Childrens Fund (UNICEF) in the document 'Expert consultation on oral rehydration salts formulation 18 July 2001.'
                                                                                                                                             c) the following warning statements are required on the medicine label:
                                                                                                                                             - (UOAD) 'Use only as directed.'
                                                                                                                                             - (DIAR) 'If diarrhoea persists for more than 6 hours in infants under 6 months - 12 hours in children under 3 years - 24 hours in children aged 3-6 years or 48 hours in adults and children over 6 years - seek medical advice (or words to that effect).'
                                                                                                                                             - (DIAR3) 'If diarrhoea persists, seek medical advice.'