Berocca Boost effervescent tablet (Bayer Australia Ltd)
Product Name
Berocca Boost effervescent tablet
Sponsor
Date of review outcome
Date of publication
Dec-22
Outcome
Medicine continues to be permitted for supply
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 tablet 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). 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 updated the labels with the maximum daily dose of pure caffeine to be below the permitted limit.
Additional information
This medicine was targeted to check its compliance in relation to quantity restrictions and warning requirements for the substance caffeine