AKSON COLLEGE OF HEALTH
SCIENCES MIRPUR AJK 6-1
6-2
Raw materials Final product
processing
It is complete but
with lost
identity…………
Contents
What is Label?
Need of a label
Types of a label
Manufacturer label
Legal requirements
Dispensing label
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LABEL
“ Label means a display of written, printed or graphic
matter upon immediate container or the wrapper of a
drug package”
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TYPES OF LABEL
Manufacturer label
Dispensing label
Manufacturer label
• A label which contain drug information for the use of
medical practitioners, pharmacists, or nurses
supplied by the manufacturer, packer, or distributor
of the drug
(FDA)
LEGAL REQUIRMENTS OF A
MANUFACTURER LABEL
1. The name of preparation
2. Strength and dosage form.
3. Quantity.
4. Instructions for the use.
5. Precautions & warnings.
6. Registration number.
7. Batch number.
8. Manufacturing & Expiry date .
9. Price
10.The name and address of pharmaceutical industry
NAME OF THE PREPARATION
Generic name:
According to drug labelling and packaging rules 1986:
“ International non-proprietary name means the
name of a drug as recommended by WHO or may be
notified by the federal govt. in the official gazette”
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Brand Name:
Brand name which is used to market the drug
Property of drug company
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STRENGTH
• It is amount of active drug per unit dose.
• Example: amoxicillin 250mg capsules and amoxicillin
500mg capsules.
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SPECIFICATION
U.S.P
B.P
DOSAGE FORM
• Dosage form of the medicine should be mentioned on
the label. e.g.,
• Different dosage forms of Amoxicillin
QUANTITY
Quantity /volume present per a packaging unit
The
Thecontainer
containerhold
hold20
20tablets
tabletsand
andeach
eachtablet
tablethas
has
aadosage
dosagestrength
strengthof
of500
500mg
mgper
pertablet.
tablet.
INSTRUCTIONS
Shake well before use:
Necessary on all disperse systems:
• Emusions
• Suspensions
e.g.,
Liniments
Lotions
Tinctures
Warning!!!!!
DO NOT SHAKE THE PATIENT,
SHAKE THE BOTTLE WELL BEFORE USE…….
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Precautions
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Storage conditions
Store in a cool place:
1. Not more than 0˚C-8˚C is necessary for many
products
Protect from light:
Necessary for light sensitive preparations.
Light resistive containers should be used.
Keep out of the reach of children
All dispensed medicines should carry this information
on label
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For external use only:
Inflammable:
If the preparation contain 50% or more alcohol or any
other inflammable solvent, the label should contain
word inflammable
Not to be taken:
Liquid preparation that are not administered by mouth
For nasal drops, enemas and nasal sprays
Unit dosage forms e.g., pessaries and rectal suppositories
Help to administer drugs safely
Types of warnings
If hypersenstivity to a drug
For controlled substances
About combining with other drugs or products
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Registration number
“A number given to a specific drug when it is
registered according to specific rules by registration
board set up by federal government”
Batch number
Acc. to drug act 1976
“A designation printed on label of a drug that
identifies the batch and permits the production
history of the batch including all stages of
manufacturer and control to be traced and are
viewed”
Manufacturing date
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Expiry date
Accorrding to drug act 1976 S 3
“Date stated on the label of a drug after which a drug
is not expected to retain its claimed efficacy, safety,
quantity, or potency or after which it is no permissible
to sell the drug”
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Liscense number
Biological products are approved for marketing under
the provisions of the Public Health Service (PHS) Act.
The Act requires a firm who manufactures a biologic
for sale in interstate commerce to hold a license for
the product
Manufacturer information
Name
Adress
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Price
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Barcodes
“It is an optical machine readable representation of
data, which shows data about the object to which it
attaches”
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McGraw-Hill 6-37
It includes:
Drug name and quantity
Patient name
Prescription number
Phone number
Instruction for use
Pharmacy name and
address
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McGraw-Hill 6-40
Includes the
information about:
1. Directions for use:
How to take a medicine
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EAR DROPS
For external use only
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AEROSOLS INHALATIONS
Pressurized containers
keep away from heat
source
Shake before use
Do not exceed the
prescribed dose
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CREAMS
For external use only
Store in cool place
Interactions
• Certain drugs may have serious reactions if eat with
particular food or drugs,e.g:
a)Amine containing foods (tyrosine) with monoamine
oxidase inhibitors.(hypertension crises)
b)Tetracycline with milk
REFERENCES:
1. Mannual of drug laws 2014
2. Dispensing for pharmaceutical students pharmacy by S.J
Carter
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