HELP@HAND FOR COUGH, COLD & FLU RELIEF DAY & NIGHT (Nova Pharmaceuticals Australasia Pty Ltd)
Product Name
HELP@HAND FOR COUGH, COLD & FLU RELIEF DAY & NIGHT
Date of review outcome
Date of publication
Dec-2023
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?
Be aware this medicine contains blue capsules for day use and orange capsules for night use. The colours of this medicine's labels (on carton and blister packs) may be confusing in relation to which capsules are for day and night use. Always read the labels and follow the directions for use.
Review scope
Targeted
Information reviewed
ARTG Record, Labels, Manufacturing Documentation
Issues related to safety
The label for this medicine includes colour-coded texts and images that have the potential to mislead consumers to take the incorrect capsule at the wrong time. Night-use capsules contain the herbal ingredient Valeriana officinalis, which can cause drowsiness.
However, the directions for use on the carton label correctly instruct consumers to take the blue day-use capsules during the day and the orange night-use capsules at night. Additionally, the label also advises consumers 'do not drive or operate heavy machinery after taking a night capsule'. As such, this medicine is unlikely to pose an immediate risk to consumer health and safety.
However, the directions for use on the carton label correctly instruct consumers to take the blue day-use capsules during the day and the orange night-use capsules at night. Additionally, the label also advises consumers 'do not drive or operate heavy machinery after taking a night capsule'. As such, 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 labels to correct these issues.