LABELLING OF DISPENSED

MEDICINES
 Labelling
Def “The term labelling designates all labels and other written,
printed or graphic matter up on or in any package or wrapper in
which it is enclosed”.
 The label states the name of the preparation,
 Percentage content of drug of a liquid preparation,
 The amount of active ingredient of a dry preparation,
 The volume of liquid to be added to prepare an injection or
suspension from a dry preparation,
 The route of administration,
 A statement of storage condition and expiry date.
 Functions of Label
The label of a pharmaceutical product has many functions:
 To indicate clearly the contents of the container.
 To indicate clearly to patients how and when the medicinal
product should be taken or used.
 To indicate clearly to patients how the product should be stored
and for how long
 To indicate clearly to patients any warnings or cautions of which
they need to be made aware.
LABELLING REQUIREMENTS FOR
DISPENSED PRODUCTS
 The container containing the dispensed medicine is labelled
providing adequate information so that the medicine can be
taken or used properly.
INFORMATION:
 The information on the label should be:
 ACCURATE
 CONCISE
 LEGIBLE
 INTELLIGIBLE & UNAMBIGUOUS,
 ADEQUATE & RELEVANT
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
include too much information on one label.

Accurate:
➢ It is important that the title is accurate.
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
patients, they may feel overwhelmed and as a result they may
read none of the information.
Intelligible

➢ The wording of the information on the label must be in plain

English, be easily understandable and use unambiguous
terms.

➢ It must always be remembered that patients may feel

embarrassed to ask for further clarification on the meaning of
complicated words used on the label.
Adequate
➢ Ensure that sufficient information is given.
Appearance Of Label on Container
 Correct position:
 Medicine bottles:
➢ The label should be on the front of a medicine bottle about a
third of the way down the container.
 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.
 Ensure that the patient can open the container without destroying
the label (e.g. when labelling cartons).
 Ensure the label is positioned with care and is straight, not
crooked.
 Clean:
➢ 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.
 Secure:
➢ Ensure that the label is secure before dispensing the product
to the patient.
➢ The main reason for labels not sticking to product containers
is because of a dirty or greasy container.
 Components of dispensed labels
 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.).
 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.
 All labels must state the name of the product dispensed, the
strength where appropriate, and the quantity dispensed.

Products for internal use:

➢ The title of an extemporaneous preparation should be given if it is
an official product (that can be found in an 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 labeled ‘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, formula is expressed as
the amount of ingredient per unit dose.
➢ For example:
➢ The quantitative particulars for a Sodium Chloride BP solution 4%
with a dose of 10 ml bd could be labeled 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:

 Include all preparations meant for external application such as:

➢ Gels,
➢ Lotions,
➢ Ointments,
➢ Creams,
➢ Pastes,
➢ Dusting powders,
➢ Gargles,
➢ Antiseptic lotions,
➢ Skin protectives & emolients
 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 product the label title may reflect the
type of external product:
➢ e.g. ‘The Nose Drops’
➢ ‘The Ear Drops’
➢ ‘The Mouthwash’
➢ ‘The Lotion’
➢ ‘The Enema’ etc.
 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.
 For example:
➢ The quantitative particulars for 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
 Labels must also include an expiry date.
 All directions on labels should use passive rather than active
verbs. e.g. “Two to be taken” is preferable to the active form
“Take two”.
 Where possible, adjacent numbers should be separated by the
formulation name.
➢ For example, ‘Take two three times a day’ could allow for
easy misinterpretation by the patient.
➢ Ideally, the wording on this label would include the
formulation, e.g. ‘Take two tablets three times a day’.
 The frequency and quantity of individual doses are always
expressed as words rather than numerals (i.e. ‘two’ not ‘2’).
e.g. “ TWO 5ml spoonfuls” is free from misinterpretation
that might arise with “ 2 5 ml spoonfuls”.
 Liquid preparations for internal use usually have their dose
expressed as a certain number of 5 ml doses.
➢ This is because a 5 ml spoon is the normal unit provided to
patients to measure their dose from the dispensed bottle.
➢ Therefore if a prescription called for the dosage instruction
10 ml tds, this would be expressed as ‘Take two 5 ml
spoonfuls three times a day’.
➢ Paediatric prescriptions may ask for a 2.5 ml dose: in this
case, the label would be ‘Give a 2.5 ml dose using the oral
syringe or dropper provided’.
➢ Use ‘Give’ as a dosage instruction on products for children as a
responsible adult should administer them.
 Remember the label on a medicine is so that the item can be
identified, and the patient instructed as to the directions
for use. Therefore, simple language should always be used.
➢ Never use the word ‘Take’ on a preparation that is not intended for
the oral route of administration.
➢ Always be prepared to give the patient a verbal explanation of the
label.
 ADDITIONAL LABELS
 Additional labels(Warning labels or advisory labels) may also be
required.
 These may be pharmaceutical or pharmacological warnings.
 These may be
➢ Required by law.
➢ Necessary for pharmaceutical reasons e.g.
a) To indicate restrictions on the use of preparation
b) To give special instructions on use of preparation
c) To specify storage conditions and shelf life
 Generally if there is a choice between two warning labels with
equivalent meaning, the positive one should be chosen
e.g. ‘For rectal use only’ is preferable to ‘Do not swallow’ for
suppositories.
1. Required by law

 The word ‘poison’ is not used on dispensed preparation.

 If preparation is a poison one of these two labels may be
necessary :
1. ‘For external use only’
➢ Is used on any preparation intended for external use
along with description of preparation such as ‘ The
Liniments’.
➢ Products for external use include liniments, lotions,
liquid antiseptics and other liquids or gels.
➢ For example:
➢ Ointments: ‘For external use only’
➢ Pastes: For external use only’
➢ Creams and Gels: ‘For external use only’
➢ Liniments & Lotions: ‘For external use only ‘, ‘Shake the
bottle’ , ‘Avoid broken skin’.
2. ‘ Not to be taken’
➢ Used for liquid preparations other than medicines.
➢ For example antiseptic and disinfectant solution.
2. Instructions restricting use of
preparation
 Traditionally, for the following dosage forms, alternative
labels have been employed instead of ‘For external use only’
to reflect more closely the intended purpose of the product.
 These alternative labels are:
➢ Enemas: ‘For rectal use only’
 Gargles and mouthwashes: ‘Not to be taken’
➢ Inhalations: ‘Not to be taken’ or ‘Shake the bottle’
➢ Nasal drops & drops: ‘Not to be taken’ or ‘For nasal use
only’
➢ Pessaries: ‘For vaginal use only’
➢ Suppositories: ‘For rectal use only’
3.Instructions for using the
preparation
 This include :
“Shake well before use”
➢ Necessary on all liquid disperse systems such as suspensions
and emulsions.
➢ Examples:
➢ Emulsions: ‘Shake the bottle’
➢ Mixtures and Suspensions: ‘ Shake the bottle ’
➢ Liniments and Lotions: ‘ Shake the bottle ’
Special instructions
 CACHET: ’To be immersed in water for a few seconds,
placed on tongue, and swallowed with draught of water’.
(A seal-shaped capsule or wafer made of flour for enclosing
powders of disagreeable taste. The sealed dosage form is
wetted and swallowed).
 Dusting Powders: ‘Not to be applied to open wounds or
raw weeping surfaces’.
 Enemas: ‘Warm to body temperature before use’.
 Gargles and mouthwashes: ‘Do not swallow in large
amounts’
4. Instructions indicating storage
conditions and shelf life

 ‘Store in a cool place’

 Storage in a cool place not more then 15 ͦ c is necessary for
many products.
 Capsule: loss of moisture shell brittle
 Creams: to prevent drying out.
 Emulsions: high temp encourage creaming.
 Molded suppositories: melts at 37 ͦ c or above.
 Preparations containing thermolabile medicaments.
 ‘Protect from light’
➢ This label is Not necessary if product is stored in light
resistant container.
➢ A few medicaments e.g. paraldehyde must be stored in
complete darkness and must have this label.
 ‘Inflammable’
➢ Use this If preparation having alcohol 50 % or more.
 EXPIRY DATE
 Expiry date should be mentioned on label of all dispensed
products.
 PROTECTION OF CHILDREN:
 All dispensed products should carry warning:
 ‘Keep out of reach of children’.
Abbreviation Meaning

b.i.d twice a day

t.i.d three times a day

q.i.d four times a day

h.s. at bedtime

s.o.s if needed
Abbreviation Meaning Abbreviation Meaning
OTC over-the-counter
tab tablet
p.c. after meals
caps capsule
a.c. before meals
crem creams
i.c. Between meals
PO by mouth
prn when needed
PR per rectum
SL sublingual q every

IM intramuscular q6h every 6 hours

IV intravenous qhs every night at bedtime

SC, SQ subcutaneous stat at once

 Warning Cards
 Special instructions are required for patients who are:
 Under treatment with certain drugs and may have serious
reactions if
➢ Eat particular food or take certain other drugs.
➢ EXAMPLES:
▪ Amine containing foods should not be eaten by patients
taking monoamine oxidase inhibitors (MAOIs).
▪ Aspirin containing preparations should be avoided
completely by patients under treatment with coumarin
anticoagulants,
 Patients not knowing about foods containing amines.
 Or which proprietary medicine contain aspirin.
 So, the Pharmaceutical society of Great Britain recommends
that warning cards should be issues to such patients.
 Types of warning cards:
 MAOI cards – these list the amine containing foods.
 Aspirin cards – these advise patients to seek a
pharmacist’s advice whenever purchase a proprietary
medicine.
Package Inserts
 For small containers of proprietary preparations, it is
difficult to include detailed information on small label.
 These include information leaflet used inside package or box
in which container is already issued.
 Ideally it recommends that the patient’ leaflet should contain
in simple language.
 Dose related to meal times or symptoms.
 Method of use of local preparation. e.g. nasal sprays and
aerosols.