Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1776
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1776
Character Range: 854094–856963

1776                                      DIBASIC MAGNESIUM PHOSPHATE TRIHYDRATE                                                           A, E, H   Magnesium is a mandatory component of dibasic magnesium phosphate trihydrate.
                                                                                                                                                     The percentage of magnesium from dibasic magnesium phosphate trihydrate should be calculated based on the molecular weight of dibasic magnesium phosphate trihydrate.
                                                                                                                                                     When used in a medicine:
                                                                                                                                                     (a) with an oral route of administration;
                                                                                                                                                     (b) not indicated for laxative (or related) use; and
                                                                                                                                                     (c) where the maximum recommended daily dose for:
                                                                                                                                                     (i) children aged between 1 and 3 years (inclusive) provides 65 mg or more total magnesium from inorganic magnesium salts;
                                                                                                                                                     (ii) children aged between 4 and 8 years (inclusive) provides 110 mg or more total magnesium from inorganic magnesium salts; or
                                                                                                                                                     (iii) individuals aged 9 years or older provides 350 mg or more total magnesium from inorganic magnesium salts;
                                                                                                                                                     the following warning statement is required on the medicine label:
                                                                                                                                                     - (LAX6) 'Contains magnesium, which may have a laxative effect or cause diarrhoea' (or words to that effect).
                                                                                                                                                     When the route of administration is oral, the medicine must not be directed for use in infants younger than 12 months of age.