Berocca Boost oral solution (Bayer Australia Ltd)
Product Name
Berocca Boost oral solution
Sponsor
ARTG
321709
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine is no longer permitted to be supplied
Is it safe to continue using this medicine?
Yes, if you follow the recommended actions below
What action should consumers take?
Do not exceed a maximum of 1 effervescent tablet (with 250 ml water) per day. Seek advice from a healthcare practitioner if you have been taking 2 tablets per day.
Review scope
Targeted (see Additional Information below)
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The product contains an amount of pure caffeine that exceeds the permitted limit for listed medicines if taken at the labelled maximum daily dose (2 tablets in 2 bottles). Ingredient limits for listed medicines are in place to ensure their safety. While exceeding this limit is unacceptable, current data indicates that the amount in the medicine is unlikely to pose an immediate risk to consumer health and safety.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
Actions taken during the review
The TGA required the sponsor to correct the issues with the medicine. The sponsor stopped further supply of the medicine from August 2022 and committed to cancel the listing when the last batch on the market expires (August 2023).
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine