Pharmaceutical labelling

1. AKSON COLLEGE OF HEALTH
SCIENCES MIRPUR AJK 6-1

2. 6-2

3. Raw materials
Final product
It is complete but
with lost
identity…………
I am complete but with lost
identity…………
processing

6. Contents
 What is Label?
Need of a label
Types of a label
Manufacturer label
Legal requirements
Dispensing label
6-6

7. LABEL
“ Label means a display of written, printed or graphic
matter upon immediate container or the wrapper of a
drug package”
6-7

9. TYPES OF LABEL
Manufacturer label
Dispensing label

10. 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)

11. 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

12. 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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13. Brand Name:

Brand name which is used to market the drug
Property of drug company
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14. STRENGTH
•It is amount of active drug per unit dose.
•Example: amoxicillin 250mg capsules and amoxicillin
500mg capsules.
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15. SPECIFICATION
U.S.P
B.P

16. DOSAGE FORM
•Dosage form of the medicine should be mentioned on
the label. e.g.,
•Different dosage forms of Amoxicillin

17. QUANTITY
Quantity /volume present per a packaging unitQuantity /volume present per a packaging unit
Raw mterilews atFn po ridFwru ien wima ridFwr aiu
i ntuicw urswecra tI boo hc yws ridFwr…
The container hold 20 tablets and each tablet has
a dosage strength of 500 mg per tablet.

18. INSTRUCTIONS

19. Shake well before use:

Necessary on all disperse systems:
•Emusions
•Suspensions
e.g.,
Liniments
Lotions
Tinctures

20. Warning!!!!!
DO NOT SHAKE THE PATIENT,
SHAKE THE BOTTLE WELL BEFORE USE…….
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21. Precautions
6-21

22. Storage conditions
Store in a cool place:
1.Not more than 0˚C-8˚C is necessary for many
products

23. Protect from light:
Necessary for light sensitive preparations.
Light resistive containers should be used.

24. Keep out of the reach of children
All dispensed medicines should carry this information
on label

25. 6-25

26. For external use only:

27. Inflammable:
If the preparation contain 50% or more alcohol or any
other inflammable solvent, the label should contain
word inflammable

28. 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

6-28

29. 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”

30. 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”

31. Manufacturing date
6-31

32. 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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33. 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

34. Manufacturer information
Name
Adress
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35. Price
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36. Barcodes
“It is an optical machine readable representation of
data, which shows data about the object to which it
attaches”
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37. McGraw-Hill 6-37

38. It includes:
Drug name and quantity
Patient name
Prescription number
Phone number
Instruction for use
Pharmacy name and
address
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40. McGraw-Hill 6-40

41. Includes the
information about:
1.Directions for use:
How to take a medicine
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42. EAR DROPS
For external use only
2-42

43. AEROSOLS INHALATIONS
Pressurized containers
keep away from heat
source
Shake before use
Do not exceed the
prescribed dose
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44. CREAMS
For external use only
Store in cool place

45. 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

46. REFERENCES:
1.Mannual of drug laws 2014
2.Dispensing for pharmaceutical students pharmacy by S.J
Carter
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