Recommended paracetamol doses
Consumers may be aware that that in the USA and the UK there have been recent changes to the recommended dosages of some paracetamol-containing products.
The TGA has considered these changes and recommends that there should be no change to recommended paracetamol dosing regimens in Australia.
Recent changes to the recommended use of paracetamol in the USA and UK are as follows:
- On 28 July 2011, McNeil Consumer Healthcare announced their decision to reduce the maximum recommended adult dosing on their paracetamol 500 mg Tylenol products, from 4000 mg to 3000mg per day. This change was instigated by McNeil, not the USA Food and Drug Administration.
- On 6 June 2011, the Medicines and Healthcare products Regulatory Agency (MHRA) in the UK announced that the paracetamol dosage instructions for children are to be changed in the UK by the end of 2011. The new UK dosing has a larger number of narrower age bands and defines a single dose per age band. For example, the current UK dosage system has a single age band of 6-12 years, whereas the new UK dosage system has three separate age bands: 6-8 years, 8-10 years and 10-12 years.
The safety of paracetamol
Paracetamol is a safe medicine for pain relief and fever reduction when:
- used in accordance with the directions on the label
- care is taken not to use more than one medicine containing paracetamol at the same time.
Paracetamol overdose can result in liver damage and, at very high dosages, can be fatal.
There is a particular concern in the USA about the frequency of liver failure due to overdose with paracetamol, and the United States Food and Drug Administration has been monitoring the situation closely.
Adult dosing of paracetamol in Australia
In Australia, the recommended paracetamol dosing for adults and children 12 years and over is 500 to 1000 mg every four to six hours as necessary, with a maximum of 4000 mg in any 24 hour period.
Child dosing of paracetamol in Australia
In Australia, labels on liquid paracetamol products contain clear dosing instructions. The optimal dosing for children (1 month to 12 years) is 15 mg per kg, which can be given every four to six hours as required, with no more than four doses in 24 hours. Details of accurate dosing instructions are included on pages 104 to 106 of the Australian Regulatory Guidelines for Over-The-Counter Medicines.
Requirements in Australia for medicines containing paracetamol
In Australia, medicines containing paracetamol must:
- contain clear dosing instructions
- contain warnings for safe use
- a warning not to take with any other medicine containing paracetamol
- instructions to patients on what to do in the event of overdose
- stress the risk of paracetamol overdose with clear advice:
- not to take more than eight tablets or capsules per day
- not to take for longer than a few days without medical advice
- be in child-resistant containers
- be in packs of limited quantity
- packs containing 21 or more tablets or capsules can only be sold by pharmacies as from 1 September 2013 (previously 26 or more)
These are Australian requirements, and not all apply in the USA or UK.
What the TGA is doing
The TGA is aware that there is a renewed international regulatory interest in the most appropriate dosing regimens for paracetamol. The TGA is:
- monitoring the actions of international regulatory agencies
- continuing to monitor the current use and misuse of products that contain paracetamol in Australia.
Report a problem
To report a problem with a medicine or medical device, please see Report a problem with a therapeutic product.