Little Coughs (Care Pharmaceuticals Pty Ltd)
Product Name
Little Coughs
Sponsor
Date of review outcome
Date of publication
Jun-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?
Do not use in children under 2 years of age without medical advice
Review scope
Targeted
Information reviewed
ARTG Record, Advertising (other), Labels, Website
Issues related to safety
The label, leaflet, and website for this medicine included an incorrect version of the mandatory warning statement 'Not to be used in children under 2 years of age without medical advice'. They also included the statement '6 months+' and directions of use for children under 2 years of age. As such, parents or carers may unsafely use this medicine in children under 2 years of age without consulting their doctor, which may lead to adverse outcomes.
While this is unacceptable, the label, leaflet, and website advised consumers to see a health professional if symptoms persisted, and the website has been amended to include the correct warning statement. In addition, current data indicates that use of this medicine is unlikely to pose an immediate risk to consumer health and safety.
While this is unacceptable, the label, leaflet, and website advised consumers to see a health professional if symptoms persisted, and the website has been amended to include the correct warning statement. In addition, current data indicates that use of 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 issues with this medicine. The sponsor updated the ARTG record, label, website, and other advertising for this medicine to correct the issues.