BIOLyte Oral Rehydration Solution with prebiotic and zinc (Orange flavour) (Neptune Bio-Innovations Pty Ltd)

The label for the medicine did not appropriately declare the presence of ‘sugars’. Ingredient and substance declarations for listed medicines, including the way they are described on a label, are in place to ensure safe use by consumers who may be affected by their presence. However, this is unlikely to pose an immediate risk to consumer health and safety as the label contained references to both the presence of sucrose and glucose contained in the medicine. Additionally, the label and website of the medicine advertised its use for gastroenteritis which is a serious condition requiring diagnosis, treatment or supervision by a suitably qualified health professional. This is not permitted for medicines that are available for self-selection without prior evaluation by the TGA. The references to gastroenteritis have the potential to lead consumers with this condition to delay access to timely medical advice or treatment when required, resulting in adverse outcomes. However, the label also warns consumers to seek medical advice if symptoms persist. As such, the medicine is unlikely to pose an immediate risk to consumer health and safety.