Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_2197
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 2197
Character Range: 1054371–1056510

2197                                      FERRIC PYROPHOSPHATE                                       A, H      When for internal use, iron is a mandatory component of ferric pyrophosphate.
                                                                                                               When for internal use, the medicine must contain a daily dose of no more than 24 mg of iron.
                                                                                                               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 than 1%).
                                                                                                               Divided preparations with a dose of more than 5 mg of elemental iron per dosage unit and more than 250 mg of elemental iron in the total contents of the container are required to have a child resistant closure.
                                                                                                               Undivided preparations containing more than 250 mg 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).