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

6 April 2021

This consultation closed on 18 May 2021.

The Therapeutic Goods Administration (TGA) conducted a public consultation and sought 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.

For more information and to participate in the consultation, please visit consultation hub.


The consultation opened on Tuesday 6 April 2021. Interested parties responded by close of business, Tuesday 18 May 2021.


Any questions relating to submissions should be emailed to