Vitamin C 1000 Advanced (Global Therapeutics Pty Ltd)
Product Name
Vitamin C 1000 Advanced
Sponsor
ARTG
283381
Date of review outcome
Date of publication
Sep-20
Outcome
Medicine continues to be permitted for supply
Is it safe to continue using this medicine?
Yes, however use of the medicine may pose a safety risk for some people. Follow the recommended actions below.
What action should consumers take?
The maximum daily dose recommended on the label of this medicine contains 156.6 mg of sodium. Consider whether the medicine is right for you if you follow a low-sodium diet.
Review scope
Random
Information reviewed
Labels, ARTG Record
Issues related to safety
The label of the medicine was missing the mandatory warning statement: ‘The recommended daily dose of this medicine contains 156.6 mg of sodium’. The declaration of the sodium content is in place to ensure the safe use of listed medicines. The label of this medicine recommends a maximum of 4 tablets a day, equivalent to 156.6 mg sodium. As the daily recommended sodium intake for adults is 2000 mg a day, the amount of sodium in the maximum daily dose is unlikely to pose an immediate risk to consumer health and safety even for those following a low-sodium diet.
Issues related to efficacy
The efficacy of the medicine was not assessed as part of this review
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 identified issues.