Labelling


The Therapeutic Goods Administration (TGA) regulates all aspects of medicines, including labelling. The TGA decides the type of information that has to be included on labels.

The label is the single most important piece of information for self care products. The information helps you select products that are suitable for you. It also helps you understand how to use them properly.

It is therefore critical that the information is presented in a way that the information can be understood and acted on by the consumer.

To help the medicines industry design usable self care product labels for consumers, the Labelling Code of Practice has been developed. It provides a set of principles for developing labels with the consumer in mind – these are called consumer-focused principles.

Labels designed using consumer-focused principles help consumers to:

  • identify products, differentiate and choose an appropriate product for their needs;
  • find and appropriately action instructions for using the product safely and effectively; and
  • know where to find further information if they need to know more about the product.

What’s on the label?

The label includes important information about a medicine’s ingredients, what the medicine will do and how to use it properly. So read the label carefully and follow all the directions.

Information that is on the label includes:

  • the brand name of the product;
  • names of active ingredients and how much is in each dose;
  • what the product is used for;
  • the number of doses in the pack;
  • dosage instructions – who the product can be given to, how much to take and how often;
  • warnings – these tell you when the product should not be used and about any side effects. For example:
    • care needs to be taken not to use two products that contain paracetamol;
    • St Johns Wart should not be taken with medicines containing warfarin;
    • some products may not be appropriate if you have high blood pressure or heart problems;
    • some products may cause you to be sleepy and should not be taken if you need to drive;
  • names of other ingredients that may cause problems – some people are allergic or very sensitive to substances such as lactose, gluten, shellfish, nuts, colours or preservatives, or need to know how much of substances such as sugar or salt are in the product;
  • ‘use by’ or ‘expiry’ date – you should not use the product after this date as it may be less effective;
  • storage conditions – storing the product as recommended on the label will help ensure its effectiveness until its ‘use by’ or ‘expiry’ date;
  • batch number – this number identifies a particular manufactured batch or lot. It helps to trace or recall a particular batch if necessary;
  • tamper evident statement – helps identify if the product has been opened or tampered with;
  • name and address of the manufacturer; and
  • AUST R or AUST L number – the number shows that the medicine has been accepted by the Therapeutic Goods Administration for supply in Australia.