Listed medicines using indications related to diarrhoea requiring a warning statement

The Therapeutic Goods Administration (TGA) conducted targeted compliance reviews of selected listed medicines using indications related to diarrhoea that are required to display the following warning statement:

• ‘Seek medical advice if diarrhoea persists for more than: 6 hours in infants under 6 months, 12 hours in children under 3 years, 24 hours in children aged 3 to 6 years or 48 hours in adults and children over 6 years (or words to that effect).’

The review found that 93% of the targeted medicines complied with the required warning statement, while 7% were missing it. Sponsors of non-compliant medicines were required to update their product labels and/or advertising materials to address the issue.

If you are a sponsor of a listed medicine that uses indications related to diarrhoea, you are encouraged to review the Therapeutic Goods (Permissible Indications) Determination to ensure that all indications used in your products meet the relevant requirements—including the inclusion of the appropriate warning statement on the label. 

Visit the Compliance and education for listed medicines page for more information.