Published: 29 March 2021
Revised: 15 April 2021


Outcome of the consultation on the proposed changes to paracetamol warning and advisory statements


  • Medsafe sought comments on plans to introduce new labelling requirements for non-prescription products containing paracetamol.
  • Medsafe received 72 responses to the consultation.
  • Download the Consultation outcome document to view the consultation feedback, Medsafe’s response and the finalised warning statements:
    Proposed changes to paracetamol warning and advisory statements – Consultation outcome (PDF, 1192 KB, 54 pages)
  • The implementation date for the statements for existing products will be 1 October 2022 for solid oral dose forms and suppositories, and 1 April 2023 for liquid dose forms.

About the consultation

This Medsafe consultation proposed new warning and advisory statements for non-prescription products containing paracetamol. The review of the statements arose from a recommendation of the Medicines Adverse Reactions Committee to improve the safety of paracetamol use in New Zealand following a report of acute liver failure in a young child.

The consultation opened on 4 November 2019 and closed on 31 January 2020.

More information about the consultation.

Submissions received

There were 72 responses to the consultation. Respondents included members of the public, health care professionals, industry, professional bodies and government organisations. Most respondents were supportive of the labelling changes.

You can view the submissions that we have permission to publish.

Medsafe would like to thank all those who took the time to respond to the consultation and provide comments.


The information below is only a brief summary of the consultation outcomes. For the full consultation feedback and Medsafe’s response, please download the consultation outcome document.

Based on respondent feedback, we have made some changes to the proposed statements – see the consultation outcome document for details.

Key changes are as follows.

  • The paracetamol liquid dosing table has been changed to include two dose volume rounding options, remove the overlap from the age brackets and reduce the dose for the 1-2-month age bracket.
  • A statement that it is mandatory to supply a dosage device with over-the-counter paracetamol products has been added.
  • For liquid paracetamol products, the statement, ‘Always make sure the cap is on this bottle correctly’ has been added.
  • For modified release paracetamol products, the statement, ‘Do not crush or chew these tablets’ has been added.
  • The statement CONTAINS PARACETAMOL has been added for products that do not have paracetamol as part of the trade name.
  • There has been minor rewording of some statements to make them more consumer friendly.

Implementation date

The proposed implementation date for the new warning statements was 1 October 2022. However, based on feedback from industry, the implementation date has been revised to:

  • 1 October 2022 for solid oral dose forms and suppositories
  • 1 April 2023 for liquid dose forms.

Medicines released for supply in New Zealand after these dates must have updated package labels. It is expected that all New Medicine Applications will comply with the updated labelling requirements, unless alternative arrangements have been agreed with Medsafe.

The Label Statements Database has been updated to this effect.


Any questions relating to this consultation should emailed to:

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