Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1531
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1531
Character Range: 746218–749855

1531                                      COLA ACUMINATA                                                                                   A, E, H   Caffeine is a mandatory component of Cola acuminata.
                                                                                                                                                     When the medicine is packaged for supply as a divided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 33%.
                                                                                                                                                     When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 400 mg of total caffeine.
                                                                                                                                                     When the medicine is packaged for supply as an undivided preparation and is for internal use or oral application, the medicine must not contain a concentration of total caffeine greater than 1%.
                                                                                                                                                     When the medicine is for internal use or oral application, a maximum recommended dose of the medicine must not provide more than 100 mg of total caffeine within a 3 hour period.
                                                                                                                                                     When the maximum recommended daily dose of the medicine provides greater than 10 mg of total caffeine and the medicine is for internal use or oral application, the following warning statements are required on the label:
                                                                                                                                                     - (ADULT) 'Adults only' (or words to that effect).
                                                                                                                                                     - (CAFF) 'Contains [state quantity per dosage unit or per mL or per gram of product] total caffeine [per dosage unit or per mL or per gram]. A cup of instant coffee contains approximately 80mg of caffeine.'
                                                                                                                                                     - (CAFFPREG) 'Caffeine intake more than 200 mg per day is not recommended during pregnancy or breastfeeding.'
                                                                                                                                                     When the maximum recommended daily dose of the medicine provides greater than 80 mg of total caffeine and the medicines is for internal use or oral application, the following warning statements are required on the label:
                                                                                                                                                     - (CAFFLMT) 'Limit the use of caffeine-containing products (including tea and coffee) when taking this product.'
                                                                                                                                                     - (CAFFCYP) 'Caffeine interacts with enzyme CYP1A2 in the liver. Consult your health professional before taking with other medicines' (or words to that effect).