Labels on medicines and poisons

Poisons must be labelled in accordance with Part 2 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (external site).

The SUSMP stipulates that labels must be in English and there are also rules about the size and visibility of the words printed on labels.

Poisons for use by consumers must be labelled with the appropriate signal heading (Caution for Schedule 5 and Poison for Schedule 6), the words “Keep out of reach of children”, the names, strength and quantity of the poisons in the product, relevant first aid and safety directions and the name and street address of the manufacturer or distributor in Australia. Certain poisons will require additional information on their labels.

Registered pesticides, including home garden products, will have labels approved by the Australian Pesticides and Veterinary Medicines Authority (APVMA).

Poisons that will only be supplied for use in industrial or manufacturing workplaces, laboratories or dispensaries, are allowed to be labelled in accordance with WorkSafe requirements instead of SUSMP requirements (see Department of Commerce (external site) for further information).

Prescription medicines and controlled drugs supplied to patients by both pharmacists and prescribers (including veterinary surgeons) must be labelled in accordance with Appendix L of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (external site).

Labels must be in English and include the following information:

• “KEEP OUT OF REACH OF CHILDREN” (in red on a white background)
• generic or brand name of the medicine
• strength and form of the medicine
• directions for use
• total quantity in the container
• patient name
• name, address and telephone number of the supplying pharmacy/ prescriber
• date of supply.

Pharmacists must also include the prescription reference number corresponding to the record made in their dispensing system.

Where the medicine is supplied for an animal, the species of animal and the name of the animal’s owner must be on the label as well as the words “FOR ANIMAL TREATMENT ONLY”.

Where the medicine is for topical use, the words “FOR EXTERNAL USE ONLY” or “POISON” must be added (in red on a white background).

Some medicines also require additional label warnings. For example, oral retinoids must have warnings about becoming pregnant.

Sedation warnings

Medicines listed in Appendix K of the SUSMP (exernal site) must be labelled with a sedation warning when supplied to patients. Pharmacy cautionary advisory label 1 or label 1A should be used.

Medicines for use only within a hospital or health care facility (for example, for administration to inpatients) do not require this additional label.

Medicines supplied by manufacturers and wholesalers must be labelled in accordance with Part 2 of the Standard for the Uniform Scheduling of Medicines and Poisons (SUSMP) (external site).

Human medicines supplied across Australia will have labels approved by the Commonwealth Therapeutic Goods Administration (TGA). Similarly, veterinary drugs will be labelled in accordance with the requirements of the Australian Pesticides and Veterinary Medicines Authority (APVMA).

Over the counter medicines

Medicines in Schedule 2 and Schedule 3 should be supplied in the manufacturer’s original pack with all warnings and dosage instructions visible.

Pseudoephedrine products must be labelled with the name and address of the supplying pharmacy and the transaction code generated by Project STOP.