Rehydraid Ready to use Apple Raspberry Electrolyte Solution (Redland Pharmaceuticals Pty Ltd)
Product Name
Rehydraid Ready to use Apple Raspberry Electrolyte Solution
Sponsor
Date of review outcome
Date of publication
Sep-2026
Outcome
Medicine continues to be permitted for supply. Batches manufactured from 19 August 2026 must carry a corrected label.
Is it safe to continue using this medicine?
Yes, based on the sponsor's certification. However, follow the recommended actions below.
What action should consumers take?
Seek advice from a doctor if you have been or are intending on using this medicine for the relief of dehydration caused by heat exhaustion, or for the prevention, treatment or management of dehydration during pregnancy.
If symptoms persist, talk to your health professional.
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.
Always read the label and follow the directions for use.
This medicine contains sugars, potassium, sodium, benzoates and sorbates. Consider whether this medicine is right for you if you have allergies or sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health professional.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to preventing dehydration, or in relation to fatigue relief and energy restoration.
If symptoms persist, talk to your health professional.
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.
Always read the label and follow the directions for use.
This medicine contains sugars, potassium, sodium, benzoates and sorbates. Consider whether this medicine is right for you if you have allergies or sensitivities to these substances. If you develop a reaction, discontinue use and consult a suitably qualified health professional.
Consider whether this medicine is right for you based on it potentially not working as expected in relation to preventing dehydration, or in relation to fatigue relief and energy restoration.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Website
Issues related to safety
The labels and website for this medicine contained claims outlined 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 professional, which may result in adverse outcomes.
This medicine contains sugars, benzoates and sorbates. The labels did not declare the presence of sugars and declared the presence of benzoates and sorbates in a manner inconsistent with requirements for listed medicines. These substances are required to be declared on the labels of medicines that contain them, as they may cause adverse reactions in individuals with allergies or sensitivities to these groups of substances.
The labels and website for this medicine expressed the amount of sodium and potassium in multiple ways which may cause confusion for individuals with sensitivities to these substances.
The website for this medicine was missing the mandatory warning statements as set out under 'What action should consumers take?'. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine.
While these safety issues are unacceptable, the labels and website have been updated, the labels include the mandatory warning statements, and current data indicates that this medicine is unlikely to pose an immediate risk to consumer health and safety.
This medicine contains sugars, benzoates and sorbates. The labels did not declare the presence of sugars and declared the presence of benzoates and sorbates in a manner inconsistent with requirements for listed medicines. These substances are required to be declared on the labels of medicines that contain them, as they may cause adverse reactions in individuals with allergies or sensitivities to these groups of substances.
The labels and website for this medicine expressed the amount of sodium and potassium in multiple ways which may cause confusion for individuals with sensitivities to these substances.
The website for this medicine was missing the mandatory warning statements as set out under 'What action should consumers take?'. These warning statements are necessary to ensure the safe use of this medicine and to alert consumers to safety risks prior to taking this medicine.
While these safety issues are unacceptable, the labels and website have been updated, the labels include the mandatory warning statements, and current data indicates that this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The labels and website for this medicine contained claims outlined in 'What action should consumers take?' above. However, these claims were not covered by the sponsor’s certification that they held evidence to substantiate them.
Actions taken during the review
The TGA issued a letter to the sponsor outlining the issues with this medicine. The sponsor updated the labels and website to correct the issues with this medicine, and the TGA provided the sponsor with an educational letter to remind them of their regulatory responsibilities.