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PHENERGAN ELIXIR promethazine hydrochloride 1 mg/mL bottle (reformulation), Sanofi-Aventis Healthcare Pty Ltd, CON-777
Product name
PHENERGAN ELIXIR promethazine hydrochloride 1 mg/mL bottle (reformulation)
Sponsor name
Sanofi-Aventis Healthcare Pty Ltd
Batches
71
Consent start
Consent no.
CON-777
Duration
The consent is effective from 1 April 2021 until 31 December 2021.
Standard
Subsections 8(2), 9(3) and 9(4) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription medicines
Non-compliance with standard
The products do not conform to the requirements of subsections 8(2), 9(3) and
9(4) of Therapeutic Goods Order No. 92 – Standard for labels of non-prescription
medicines in that the carton label does not have the critical health information
presented in a tabulated format;the name and quantity of the active ingredient
is not placed directly below the name of the medicine on the carton and bottle
label; andall the text required by the order to be on the main label are not
oriented in the same direction on the carton label.
Import, Supply, &/or Export
Supply
Therapeutic product type
Over-the-counter medicines