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What's on a medicine label?

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Buying medicines - What's on the label for me?

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What's so special about the label?

When you buy prescription or over-the-counter medicines, a sunscreen or a vitamin supplement, it is crucial that you have certain information to help you make an informed purchase.

The label tells you what you are buying, what it can do for you and how to use it to get the best results. It provides important information about storage conditions and the expiry date.

Labelling is part of the national system of regulating medicines. Most of these products must be included in the Australian Register of Therapeutic Goods, with a small number exempt.

What do the Aust R and Aust L numbers mean?

They show that the medicines are accepted by the Therapeutic Goods Administration for supply in Australia and are included in the Register. The number is printed on the outer packaging so that it can be seen easily.

AUST R medicines are assessed for safety, quality and effectiveness. They include all prescription only medicines and many over-the-counter products such as those for pain relief, coughs and colds and antiseptic creams.

Prescription only medicines do not display their purpose on the label as the decision for using them lies with a doctor; however, over-the-counter medicines must have a purpose displayed.

AUST L medicines can only contain pre-approved low-risk ingredients. They are used for minor health problems and are reviewed for safety and quality. They include sunscreens over SPF4 and many vitamin, mineral, herbal and homoeopathic products. A purpose must be included on the label.

What about other key information?

Other important information relating to the quality and safe use of the product must be on container labels and the outer packaging. You should read this information and closely follow any directions. This information includes:

  • STORAGE CONDITIONS - labels must show how to store the product such as "Store below 30°C" which in most parts of Australia means room temperature. Some medicines must be stored in a refrigerator.
  • EXPIRY DATE - this is similar to the use-by date on food products at the supermarket. The medicine should not be used after this date because it can lose its effectiveness or become unsafe.
  • BATCH NUMBER & COMPANY NAME & ADDRESS - the batch number and name and address of the supplier must be on the labels and can be used to trace the medicine if a problem is found.

Always read the labels on medicines

checkCheck to see if there is an AUST R or AUST L number.

checkUnless it has been prescribed by a doctor, check the medicine's uses to make sure they are suitable for your needs.

checkRead carefully all directions and warnings, and always follow them.

checkCheck the storage conditions including the recommended temperature.

checkCheck the expiry date. When the date is reached, safely dispose of any remaining medicine.

checkSee if the batch number and supplier's name and address are visible.

This brochure is produced as a service for consumers and health professionals and has been jointly prepared by Commonwealth, State and Territory governments, industry and consumer organisations. Further copies can be obtained from the Therapeutic Goods Administration, PO Box 100, WODEN ACT 2606 (telephone 02 6232 8610, freecall 1800 020 653, fax 02 6232 8605)

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Content last updated: Wednesday, 5 March 2014

Content last reviewed: Wednesday, 26 June 2013

Web page last updated: Wednesday, 5 March 2014

URL: http://www.tga.gov.au/consumers/information-medicines-label.htm