Australian Approved Name (AAN): Sodium bicarbonate
Common names and synonyms: Sodium bicarbonate anhydrous; Sodium hydrogen carbonate
Organic/Inorganic: Inorganic
Molecular formula: NaHCO3
Molecular weight: 84.01
Conversions (% sodium): 27.37
AI for Sodium as per NHMRC:
Infants – 0-6 months – 120mg/day
Infants – 7-12 months – 170mg/day
Children – 1-3 years – 200-400mg/day
Children – 4-8 years – 300-600mg/day
Children – 9-13 years – 400-800mg/day
Children – 14-18 years – 460-920mg/day
Adults – 460-920mg/day
Pregnancy & Lactation – 460-920mg/day
Warnings and Restrictions: 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.
Allowable purpose of the ingredient: Active. Excipient
TGA reference: British Pharmacopoeia