Pharmaceutical labelling

Pharmaceutical labelling

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Pharmaceutical labelling

A label is an important, integral part of a drug and never should a patient receive a medicine without a proper label which gives clear instructions on how and when to take or use the drug. Further, the label contributes as well to a good appearance of the dispensed medicine, thus increasing the confidence of the patient. Therefore the label should be written in a legible, neat and well balanced way.

The main label should clearly state:

  • The name (underlined) and the quantity of the preparation.
  • The patient’s name.
  • The date of dispensing
  • Precise directions to the patients.
  • The expiry date, where applicable and/or manufacturing date.
  • The name of the dispenser (initials)
  • The name and address of the dispensing institution.

All labels must state the name of the product dispensed, the strength where appropriate, and the quantity dispensed.

All labels for dispensed medicines must have the name of the patient – preferably the full name, not just initials – and if possible the title of the patient (Mr, Mrs, Miss, Master, Ms etc.) as this helps to distinguish between family members. The date and the name and address of the pharmacy are also legally required. This will normally automatically appear on most computer labelling systems with the date being reset automatically. The words ‘Keep out of the reach of children’ are also legally required, but most labels used for dispensing purposes are already pre-printed with these words.

Any additional information or instructions are given on the auxiliary label.

Preparations to the skin should be labeled “For External use Only” in red, those to be used in the mouth and throat, but are not to be swallowed; get the auxiliary label “ Not to be Swallowed”. “Not to be Taken” is used for liquid preparations which are not administered orally and which are not applied to skin surfaces such as ear drops, nasal drops and enemas and for solids dosage forms which might, by error, be administered by the oral route such as inhalation capsules, pessaries and solution tablets.

Alternatively, such preparations can be labeled with instructions on the restricted use e.g. “For use in the Eye only”, “For Rectal use Only” or “For Vaginal Use Only”. All heterogeneous liquid preparations, such as emulsions and suspensions, must carry the instruction “Shake Before Use”.

Dusting powders get an auxiliary label “For External Use Only”. When an oral bulk powders have been prepared with a diluent, the name of the diluent should be stated on the label.

Special storage conditions are also given on the auxiliary label such as “Store at a Cool Place! Or more precise instructions like “Store between 2º and 8ºc. Preparations containing easily inflammable liquids are labeled “Highly Inflammable” or “Keep away from Open Flames”.

All dispensed medicines should have the instructions: “Keep Out of the Reach of Children”

Appearance

Positioning

It is important to position the label with care, making sure that the patient can open the container without destroying the label (e.g. when labelling cartons) and placing the label straight, not crooked.

Medicine bottles: The label should be on the front of a medicine bottle about a third of the way down the container. The front of an internal bottle is the curved side and the front of a fluted bottle is the plain side.

Cartons: The label should be placed on the large side of the carton. If there is not enough room on a single side of the carton for the entire label, it should be placed around the carton, ensuring that all the information is visible.

Ointment jars: The label should be placed on the side of the jar, ensuring that the contents of the label are visible when the top is placed on the jar.

Cleanliness

Ensure the container is clean before packing the product, then clean the outside before affixing the label. Never pour any liquids into a pre-labelled container as this risks spoiling the label with drips of the medicament.

Security

Make sure that the label is secure before dispensing the product to the patient. The main reason for labels not sticking to product containers is dirt or grease on the outside of the container.

Information

The information on the label should be:

  • Legible: Always check label print size and quality to ensure that it can be read clearly. If there is too much information to place on one label, consider placing the additional information on a secondary label, rather than reducing the size of the print or trying to cram too much information onto one label.
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  • Concise: Although it is important that sufficient information is placed on the label, it must be remembered that it is important not to confuse the patient by placing too much information on the label. If the label contains too much information, rather than assisting the patient, they may feel overwhelmed and this may result in the patient reading none of the information.
  • Adequate: Ensure that sufficient information is given, for example the term ‘when required’ leaves the questions How much? How often? When required for what?
  • Intelligible: The wording of the information on the label must be in plain English, be easily understandable and use unambiguous terms. Patients may feel embarrassed to ask for further clarification on the meaning of complicated words used on the label.
  • Accurate: Ensure that the title is accurate, the instructions are accurate and the patient’s name is complete and accurate.

Products for internal use

The title of an extemporaneous preparation if it is an official product (i.e. one with an accepted formula that can be found in an official text). The title should be as quoted in the official text (for example, Ammonia and Ipecacuanha Mixture BP).

If it is an unofficial product (that is, a product made from an individual formula, for example a doctor’s own formula) it may be labelled ‘The Mixture’ or ‘The Solution’, etc. Unofficial products must state the full quantitative particulars on the label (i.e. the formula must be stated on the label).

For preparations intended for internal use this is expressed as the amount of ingredient per unit dose. For example, a Sodium Chloride BP solution 4% with a dose of 10 mL bd could be labelled as:

The Solution

Each 10 mL dose contains:

Sodium Chloride BP 400 mg

Freshly boiled and cooled purified water to 10 mL

Products for external use

Labels for preparations not intended for oral use require slightly different labelling. If the product being made is official the official title should be used (e.g. Sodium Bicarbonate Ear Drops BP or Sodium Chloride Mouthwash BP).

If the product is an unofficial one the label title may reflect the type of external product, for example ‘The Nose Drops’, ‘The Ear Drops’, ‘The Mouthwash’, ‘The Lotion’, ‘The Enema’, etc

As with preparations intended for oral use, unofficial products for external use need to be labelled with the full quantitative particulars. In the case of products for external use, the quantitative particulars are expressed as the complete formula. Therefore, 100 mL Sodium Chloride BP Lotion 4% would be labelled:

The Lotion

Containing:

Sodium Chloride BP 4 g

Freshly boiled and cooled purified water to 100 mL

Remember the label on a medicine is included so that the item can be identified and the patient instructed as to the directions for use. Simple language should be used.

  1. Never use the word ‘Take’ on a preparation that is not intended for the oral route of administration.
  2. Use ‘Give’ as a dosage instruction on products for children, as a responsible adult should administer them.
  3. Only use numerals when quoting the number of millilitres to be given or taken. All other dosage instructions should use words in preference to numerals.
  4. Always be prepared to give the patient a verbal explanation of the label.

Auxiliary labels and discard dates for extemporaneous preparations.

PreparationAuxiliary labelSuggested discard date
ApplicationsFor external use only4weeks
CapsulesRefer the BNF3 months
Creams and GelsFor external use only4 weeks
Dusting PowdersFor external use only Not to be applied to open wounds or raw weeping surfaces Store in a dry place3 months
Ear DropsFor external use only4weeks
Elixirs
4weeks
EmulsionsShake the bottle4weeks
EnemasFor rectal use only Warm to body temperature before use4weeks
Gargles and MouthwashesNot to be taken Do not swallow in large amounts4weeks
InhalationsNot to be taken Shake the bottle4weeks
Linctuses
4weeks
Liniments and LotionsFor external use only Shake the bottle Avoid broken skin4weeks
Mixtures and SuspensionsShake the bottle4weeks
Nasal dropsNot to be taken4weeks
OintmentsFor external use only3 months
PastesFor external use only3 months
PessariesFor vaginal use only3 months
Powders (individual)Store in a dry place Dissolve or mix with water before taking3 months
SuppositoriesFor rectal use only3 months
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