Reading a dispensing label
A dispensing label is the printed sticker a pharmacist attaches to a medicine when it is dispensed. The Poisons Standard lists what it must show: who supplied it, what the medicine is and how strong, how much is in the pack, the directions for use, the name of the person it is for, and the words “KEEP OUT OF REACH OF CHILDREN”, with a reference number and date when it is supplied on prescription.
Appendix L, clause 1 · read the label box by box
The label, box by box
The letters below are the paragraph references in Appendix L, clause 1 of the Poisons Standard. As the Standard’s introduction puts it, “Appendix L sets out the requirements for labels attached to medicines at the time of dispensing”. The rule lists the details a label must contain rather than a layout, so labels from different pharmacies can look different.
- (a)Who supplied it
- The name, address and telephone number of the dispenser. If a question comes up later about the medicine, this is the pharmacy that dispensed it.
- (b)What the medicine is
- Its approved name, its proprietary (brand) name, or both. The exception is a preparation the dispenser compounded to their own formula.
- (c)How to use it
- Adequate directions for use. For a medicine supplied on prescription, the label must also carry the directions for use set out in the prescription.
- (d)How strong, and in what form
- The strength and form of the medicine.
- (e)How much is in the pack
- The total quantity in the container.
- (f)The children’s warning
- “The words ‘KEEP OUT OF REACH OF CHILDREN’ in red on a white background.”
- (g)External use only
- For a substance meant only for external use, the word “POISON” or the words “FOR EXTERNAL USE ONLY”, also in red on white.
- (h)Who it is for
- For a medicine for people, the name of the person it was dispensed for.
- (i)Medicines for animals
- For a veterinary chemical, the species of animal, the owner’s name and the words “FOR ANIMAL TREATMENT ONLY”.
- 5(a)Prescription reference number
- Added on every medicine supplied on prescription.
- 5(b)Date supplied
- The date the prescription was supplied, unless that date is clear from the reference number.
Three rules about the print itself
Appendix L also governs how the label is printed.
Warnings added for some medicines
On top of the basic boxes, the Poisons Standard adds warning statements for particular medicines.
Sedation warnings
A dispensed medicine containing a substance listed in Appendix K must carry one of three set warnings about drowsiness. Their wording, from Appendix F of the standard:
- “This medication may cause drowsiness. If affected do not drive a vehicle or operate machinery. Avoid alcohol.”Appendix F, item 39
- “This medication may cause drowsiness and may increase the effects of alcohol. If affected do not drive a motor vehicle or operate machinery.”Appendix F, item 40
- “This preparation is to aid sleep. Drowsiness may continue the following day. If affected do not drive or operate machinery. Avoid alcohol.”Appendix F, item 90
Other required warnings
Clause 2 of Appendix L lists specific medicines that need extra warning statements when dispensed, such as warnings about pregnancy, and allows several statements to be combined into simple sentences.
Where the rule has force
The Poisons Standard is national. For a dispensed medicine, its general labelling rules give way to Appendix L: section 40 says they do not apply to a medicine supplied by a prescriber, supplied on a prescription, or prepared by a pharmacist for one patient, that is labelled under Appendix L, “unless otherwise specified in relevant State or Territory legislation”. Queensland, for example, says a dispenser must not dispense a medicine unless its labelling complies with Appendix L and, where it applies, Appendix K. Other states set their own rules in their own legislation; the TGA keeps a list of each state and territory’s medicines and poisons unit.
Other things in the box
The expiry date
By law, healthdirect says, a medicine’s packaging shows its expiry date, though the date can hide under a sticker, on a bottle’s lid or on the end of a tube. If it can’t be found, healthdirect’s suggestion is a pharmacist.
The Consumer Medicine Information leaflet
Prescription and pharmacist-only medicines each come with a Consumer Medicine Information (CMI) leaflet, healthdirect says; side effects are among what it covers, and a pharmacist can point it out.
Directions from the prescription
For a medicine supplied on prescription, the label carries the directions for use set out in the prescription. healthdirect suggests asking the doctor how and when to take a medicine, and notes that a pharmacist or the CMI can also help.