Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_3485
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 3485
Character Range: 1622916–1624617

3485                                      NICOTINAMIDE RIBOSIDE CHLORIDE                                                                A         Ribose is a mandatory component of nicotinamide riboside chloride.
                                                                                                                                                  Only permitted for use in medicines limited to oral routes of administration.
                                                                                                                                                  The maximum recommended daily dose of the medicine must not provide more than 300 mg of nicotinamide riboside chloride.
                                                                                                                                                  The following warning statement (or words to the same effect) is required on the medicine label:
                                                                                                                                                  - (NTAKEN12) 'Not to be taken by children under 12 years old.'
                                                                                                                                                  When the maximum recommended daily dose of the medicine provides greater than 230 mg of nicotinamide riboside chloride, the following warning statement is required on the medicine label:
                                                                                                                                                  - (PREG) 'Not recommended for use during pregnancy or lactation'.