Ingredients requiring the POTAS1 label warning

Information for listed medicines sponsors

The TGA has identified a discrepancy between the wording of the ‘POTAS1’ warning statement available in the Code Tables compared to the requirements for potassium chloride and glucosamine sulfate potassium chloride in the Therapeutic Goods (Permissible Ingredients) Determination (the Determination). Specifically, the warning in the Code Tables:

1. has an incorrectly assigned code of ‘POTAS’ instead of ‘POTAS1’; and
2. the warning wording also included the statement ‘Contains potassium’.

Since March 2021, the Determination has not required ‘Contains potassium’ be declared on the labels of medicines containing potassium chloride or glucosamine sulfate potassium chloride. This is because it partially duplicated a label declaration requirement for medicines containing potassium (from salts) from the Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines (TGO 92).

The Code Tables now include:

1. a warning with code ‘POTAS1’ to align with the requirement of the TGO 92: ‘Contains <state quantity of elemental potassium> mg of potassium in <dosage unit or in a stated weight or volume of medicine>.’; and
2. a warning with code ‘POTAS2’ that aligns with the label statement requirements for potassium chloride and glucosamine sulfate potassium chloride in the Determination: ‘If you have kidney disease or are taking heart or blood pressure medicine, consult your doctor or pharmacist before use. Keep out of reach of children.’.

Action for affected listed medicines sponsors

Sponsors are encouraged to review the warnings included in the ARTG entries for medicines that contain potassium to ensure:

1. alignment with the statements as included on the medicine labels; and
2. verify compliance against relevant requirements both in the TGO 92 and the Determination.

The addition and removal of warning statements is a free ARTG correction (Changing a listed or an assessed listed medicine in the Australian Register of Therapeutic Goods (ARTG)) and can be made at any time via a ‘General Listed’ application form accessed via TGA Business Services (TBS).

For more information, please direct your queries to nonprescriptionmedicines@health.gov.au.