Hydroxycut Hardcore Elite (Iovate Health Sciences Australia Pty Ltd)
Product Name
Hydroxycut Hardcore Elite
Date of review outcome
Date of publication
Mar-2024
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?
This medicine contains 100 mg caffeine per capsule. Take a maximum of 1 capsule within a 3-hour period. Seek advice from a healthcare practitioner if you have been taking more than 1 capsule within a 3-hour period.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The directions for use on the label for this medicine could lead consumers to take more than 100 mg of total caffeine within a 3-hour period, which exceeds the permitted limit for listed medicines. 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 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 issue with this medicine. The sponsor updated the label of this medicine to correct the issue.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine