Stress Guard (Pharma Botanica Pty Ltd)

The label for a batch (B 36567) of this medicine was missing the mandatory warning statement for the ingredient valerian, as set out under 'What action should consumers take?' above. In addition, the label for this batch did not note that St John's Wort affects the way oral contraceptives work and did not refer consumers to their doctor. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking it. While these omissions are unacceptable, supply of the affected batch of this medicine stopped in May 2025.
The website for this medicine contained claims specified in 'What action should consumers take?' above. These claims are not permitted for listed medicines without prior evaluation or approval from the TGA. References to non-permitted claims have the potential to lead consumers to delay access to timely advice or treatment from a suitably qualified health practitioner when required, which may result in adverse outcomes.
The website for this medicine also contained claims that this medicine has no side effects. These claims are not permitted as all medicines have the potential to cause adverse outcomes. Additionally, it may encourage consumers to take this medicine even if it is not safe or appropriate for them.
While advertising of this nature is unacceptable, the website advised consumers to talk to their health professional if symptoms persist. Furthermore, the advertising for this medicine has been removed from the website.
Current data indicates this medicine is unlikely to pose an immediate risk to consumer health and safety.