Amcal Ginger-C Tablets (Sigma Company Limited)
Product Name
Amcal Ginger-C Tablets
Sponsor
ARTG
287977
Date of review outcome
Date of publication
Sep-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?
Consider whether the medicine is right for you based on the medicine potentially not working as expected in relation to calming digestive issues beyond nausea, vomiting and symptoms of motion sickness
Review scope
Random
Information reviewed
ARTG Record, Labels, Manufacturing Documentation, Website
Issues related to safety
None
Issues related to efficacy
The label and website claimed that the medicine may calm digestive issues. However, this claim was not covered by the sponsor’s certification that they held evidence to substantiate them.
Actions taken during the review
The TGA issued an educational letter to the sponsor. The sponsor was not required to respond but was expected to correct the issues.