Australian Approved Name (AAN): Ferrous fumarate
Common names and synonyms: Ferrous fumarate anhydrous
Organic/Inorganic: Organic
Molecular formula: C4H2FeO4
Molecular weight: 169.90
Conversions (% iron): 32.87
RDI for Iron as per NHMRC:
Infants – 0-6 months – 0.2mg/day (AI)
Infants – 7-12 months – 11mg/day
Children – 1-3 years – 9mg/day
Children – 4-8 years – 10mg/day
Children – 9-13 years – 8mg/day
Boys – 14-18 years – 11mg/day
Girls – 14-18 years – 15mg/day
Men – 8mg/day
Women – 19-50 years – 18mg/day
Women – >50 years – 8mg/day
Pregnancy – 27mg/day
Lactation – 14-18 years – 10mg/day
Lactation – 19-50 years – 9mg/day
Mandatory components: Iron (when for internal use)
Maximum daily dose: 24 mg of iron (when for internal use)
Warnings and Restrictions: If the divided dosage form contains more than 5 mg of iron per dosage unit (excluding up to 10 mg of iron oxide when used as an excipient), the primary pack must contain no more than 750 mg of iron.
In undivided preparations, the primary pack must contain no more than 750 mg of iron (excluding iron oxides when present as an excipient at a quantity of no more than1%).
Divided preparations with a dose of more than 5mg of elemental iron per dosage unit and more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.
Undivided preparations containing more than 250 milligrams of elemental iron in the total contents of the container are required to have a child resistant closure.
When for internal use except for iron-containing multivitamin/mineral products indicated for general nutritional support that do not make specific iron-deficiency related claims, the medicine requires the following statement on the medicine label:
IRONDEF – Not for the treatment of iron deficiency conditions (or words to that effect).
Allowable purpose of the ingredient: Active. Homeopathic
TGA reference: British Pharmacopoeia