What's on my medicine label?

Before you use any medicine, you should read the medicine label carefully, and follow all instructions. If you are unsure or have other health conditions or medications, then you should also consult a health professional.

These are the important things you should look for on the medicine label.

Critical health information

Active ingredients

The active ingredients in a medicine are the ingredients that give it efficacy. The label displays the name and quantity of all active ingredients in the medicine.

Uses of the medicine

Medicines that you buy from the supermarket or that you select yourself from the pharmacy will display the uses of the medicine on the label.

Prescription medicines do not display a use on the label. A doctor or pharmacist may apply an additional label with the prescribed use for their patient.

Directions for use

Medicines that can be chosen off the shelf by a consumer will display directions on how to use the medicine properly, such as how much to take and how often. In some cases, the information on the label may be explained in more detail in a pack insert. The directions for use may contain some warnings related to appropriate use of the medicine, for example 'do not take this medicine for longer than three days at a time'.

Prescription medicines will have a printed label containing directions for use that are specific to the patient. These directions for use are determined by the prescribing doctor.

Warnings

Medicines that can be chosen off the shelf by consumer will include warnings on when you shouldn't use a medicine, for example if you are pregnant or while taking certain other medications. Labels may also include advisory statements such as 'see your doctor if symptoms persist'.

A doctor or pharmacist may include warnings for their patient on a prescription medicine by applying an additional label.

Declarations

Some substances/ingredients found in medicines must be declared on the label. For example, potential allergens such as egg and fish must be declared if they are likely to be in the medicine. For more information, consult our Allergies and medicines page.

Prescription medicines may make some declarations in the Consumer Medicine Information (CMI) leaflet instead of on the label. In this case, there will be a statement on the label telling you to look at the CMI.

Other important information

Storage conditions

The label will explain how to store the medicine, for example 'store below 30 degrees' or 'avoid exposure to sunlight'. Some medicines don't work as well if not stored correctly. There may also be safety concerns for some medicines like injections if they are not stored properly.

Expiry date

Medicines should not be used after their expiry date. The expiry date will be shown in the month and then year format, for example 02/27 is February 2027. Expired or unwanted medicines should be taken to your nearest pharmacy for safe disposal.

Batch number

The batch number enables the medicine's history of production to be traced, and can be used to trace a medicine if a problem is found.

Contact details

The label will include contact details for either the medicine's sponsor or distributor, including the company name and suburb. There could also be a phone number or website address. This information can be used to make an enquiry or complaint, or report a side effect.

Australian Register of Therapeutic Goods (ARTG) number

Medicines approved for supply in Australia display an ARTG number. The ARTG number starts with 'AUST' and is followed by an 'R', 'L' or L(A).

The ARTG number not only identifies the product, but is a guide to how much examination the product has received before going on sale, including whether we have assessed the medicine for efficacy. Medicines with AUST R and AUST L(A) are assessed for efficacy, while those with AUST L are not.

To learn more about how we regulate medicines, visit the 'How we regulate medicines' webpage.

Sometimes there might be other information on the label

'TGA assessed' claim

Complementary medicines that have been assessed for efficacy may include a 'TGA assessed' symbol and/or statement on the label. Only assessed listed medicines (those with an AUST L(A) number) and approved registered complementary medicines (those with an AUST R number) can use the TGA Assessed claim on their labels, but it is not mandatory.

For more information about the claimer please see the complementary medicines overview and 'What does TGA assessed mean?' webpages.

Traditional use information

Some medicines are based on a recognised history of use rather than the standards of modern, conventional medicine. This includes Traditional Chinese Medicine, Ayurvedic medicine, and Western herbal medicine.

Where the evidence supporting the use of a medicine is based on a tradition of use rather than scientific evidence, this must be stated on the label.

Homoeopathic ingredients

Where a medicine contains a homoeopathic preparation as an active ingredient, this must be stated on the label.

Full formulation details

In most cases, companies are not required to list the full formulation (all ingredients) of a medicine on the label. Some inactive ingredients (or 'excipients') in a medicine must be declared on the label, for instance some substances that cause common allergic reactions.

Country of origin

Some medicine labels may show country of origin, but this is not required given the complexities and multiple manufacturers in different countries generally involved in manufacturing medicines.

What should I do if information is not on the label?

In some cases, the label may show either more or less information. For example, there are rules for certain types of medicines such as injections, package types such as small containers, and for particular medicines.

If the information you want is not on the label, consult a health professional such as a doctor or pharmacist. You can speak to an NPS MedicineWise pharmacist on 1300 134 237. You can also contact the sponsor or distributor of the medicine using the details on the label.

We can release certain information about a medicine, such as the presence or absence of a particular ingredient. To ask us a question about a medicine, contact the TGA.