Comply with paracetamol pack size changes

If your business sells or advertises paracetamol, then you need to be aware of the new rules around pack sizes that commence on 1 February 2025.

Why these changes have been made

Each year in Australia around 225 people are hospitalised with liver injury and 50 people die from paracetamol overdose, with rates of intentional overdose highest among adolescents and young adults.

To help reduce the risk of intentional overdose, the TGA made a decision on 3 May 2023 to change the way consumers can access paracetamol products based on pack size for various paracetamol products.

The decision was informed by an independent expert report that examined the incidence of serious injury and death from intentional paracetamol overdose; advice received from the Advisory Committee on Medicines Scheduling (ACMS); and submissions from two rounds of consultation from individuals, and organisations representing consumers, healthcare practitioners and industry.

What the changes mean for non-pharmacy retailers

If you are a non-pharmacy retailer such as a supermarket, petrol station or convenience store, you will only be able to sell packs of paracetamol containing 16 tablets or capsules from 1 February 2025.

If you currently have paracetamol packs containing 20 tablets or capsules, you need to run down your stocks before 1 February 2025, or return them to the wholesaler. It will be illegal to sell packs of 20 from this date.

These restrictions cover paracetamol products and combination products, such as cold and flu medicines that contain paracetamol.

Any paracetamol tablets and capsules for general sale will also be required to be in blister packaging.

Retailers are encouraged to restrict sales to a single pack at a time.

What the changes mean for pharmacies

Pharmacies must also prepare for the new restrictions that will:

• reduce the maximum size of packs available in pharmacies without the supervision of a pharmacist (i.e. ‘Pharmacy Medicine’ packs) from 100 to 50 tablets or capsules
• make other pack sizes of up to 100 tablets or capsules available only under the supervision of a pharmacist (i.e. ‘Pharmacist Only Medicines’).

Paracetamol tablets and capsules for pharmacy sale will also be required to be in blister packaging. 

The maximum size of Pharmacy Medicine packs of individually wrapped powders or sachets of granules containing paracetamol will also be reduced in line with tablet and capsule packs.

Access to liquid, modified release and Prescription Only (Schedule 4) paracetamol is not affected by the changes. 

Temporary labelling exemptions

We are providing a 12-month period of labelling exemptions for signal words for certain Pharmacy medicine (Schedule 2) and Pharmacist Only medicine (Schedule 3) paracetamol products.

This means pharmacies and wholesalers are able to store and supply remaining stock with non-compliant signal words on the package after 1 February 2025, without the need for repacking or over-labelling. This will also allow wholesalers to keep accepting stock from sponsors or the return of stock from retailers. 

The supply of these products will need to be in accordance with their new Schedule (despite the labelling). This temporary exemption is for 12 months.

In addition, we are providing a labelling exemption until 31 January 2025 to allow pharmacies to supply newly labelled Pharmacist Only (Schedule 3) products in anticipation of the changes to the Poisons Standard, before 1 February 2025. 

This temporary exemption will cease on 1 February 2025 as these products will be compliant with the new Poisons Standard when it comes into effect.

For further information, see the Temporary labelling exemptions for paracetamol notice.