Document ID: chunk:federal_register_of_legislation:F2025L00212:clause:1_1054
Version: federal_register_of_legislation:F2025L00212
Segment Type: clause
Provision Reference: sch 1 cl 1054
Character Range: 510657–515981

1054                                      CAFFEINE                                                                                         A, E, H   When used as an excipient, only for use in topical medicines for dermal application.
                                                                                                                                                     Only for use as an active ingredient for:
                                                                                                                                                     (a) oral use in adults when the medicine consists principally of one or more designated active ingredients prescribed in Schedule 14 to the Regulations (other than caffeine); and
                                                                                                                                                     (b) Topical medicines for dermal application that are directed for use in adults only.
                                                                                                                                                     When for topical application:
                                                                                                                                                     (a) the concentration of total caffeine in the medicine must not be more than 1%; and
                                                                                                                                                     (b) the medicine must not be intended for use on broken skin.
                                                                                                                                                     When for internal use or oral application, the maximum recommended daily dose of the medicine must provide no more than 100 mg of caffeine from this ingredient.
                                                                                                                                                     When for internal use or oral application, the following warning statement is required on the medicine label:
                                                                                                                                                     - (ADULT) 'Adults only' (or words to that effect).
                                                                                                                                                     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 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:
                                                                                                                                                     - (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 80 mg 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).