Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines

Closes 18 May 2021

Opened 6 Apr 2021

Overview

The Therapeutic Goods Administration (TGA) is seeking comments from interested parties on changes to current requirements for advisory statements for labels of non-prescription medicines containing antihistamines indicated for short term use in insomnia (diphenhydramine, doxylamine and promethazine), as included in the Required Advisory Statements for Medicine Labels (RASML) document.

Why we are consulting

The TGA is requesting comments that will help ensure that the proposed advisory statements are appropriate and support the quality use of the medicines and that any label changes that would be required for these medicines are made in the most convenient, efficient and cost-effective way.

Consultation paper

Proposed changes to Required Advisory Statements for Medicine Labels (RASML): Sedating antihistamines

Providing feedback

We invite you to provide your feedback by clicking 'Make a submission' below and responding to the consultation question (by free text and/or file upload).

Have your say

Audiences

  • Academics
  • Non-government organisations
  • State government agencies
  • Commonwealth agencies
  • Health professionals
  • General public
  • Community groups
  • HPRG (TGA) Staff
  • Over-the-counter medicines

Interests

  • Non-prescription medicines