Energishot (6S Laboratories Pty Ltd)
Product Name
Energishot
Sponsor
ARTG
Date of review outcome
Date of publication
Sep-2023
Outcome
Medicine continues to be permitted for supply
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?
Do not use more than 70 ml per day. Seek advice from a healthcare practitioner if you have been using more than 70 ml daily.
Review scope
Targeted (See Additional Information below)
Information reviewed
ARTG Record, Labels
Issues related to safety
This medicine contains an amount of caffeine ingredient that exceeds the permitted limit for listed medicines if taken at the labelled maximum daily dose of 140 ml. Ingredient limits for listed medicines are in place to ensure their safety. While exceeding this limit is unacceptable, current data indicates that the amount of caffeine in the recommended daily dose of this medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of this medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with this medicine. The sponsor updated the ARTG record and label for this medicine to correct these issues.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions for the substance caffeine