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6-2
Raw materials Final product
It is complete but
with lost
identity…………
processing
Contents
 What is Label?
Need of a label
Types of a label
Manufacturer label
Legal requirements
Dispensing label
6-6
LABEL
“ Label means a display of written, printed or graphic
matter upon immediate container or the wrapper of a
drug package”
6-7
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”
6-12
Brand Name:
Brand name which is used to market the drug
Property of drug company
6-13
STRENGTH
• It is amount of active drug per unit dose.
• Example: amoxicillin 250mg capsules and amoxicillin
500mg capsules.
6-14
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 unitQuantity /volume present per a packaging unit
The container hold 20 tablets and each tablet has
a dosage strength of 500 mg per tablet.
The container hold 20 tablets and each tablet has
a dosage strength of 500 mg per 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…….
6-20
Precautions
6-21
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
6-25
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
6-28
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
6-31
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”
6-32
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
6-34
Price
6-35
Barcodes
“It is an optical machine readable representation of
data, which shows data about the object to which it
attaches”
6-36
McGraw-Hill 6-37
It includes:
Drug name and quantity
Patient name
Prescription number
Phone number
Instruction for use
Pharmacy name and
address
6-38
McGraw-Hill 6-40
Includes the
information about:
1. Directions for use:
 How to take a medicine
6-41
EAR DROPS
For external use only
2-42
AEROSOLS INHALATIONS
Pressurized containers
keep away from heat
source
Shake before use
Do not exceed the
prescribed dose
6-43
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
6-46
Pharmaceutical labelling
Pharmaceutical labelling

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Pharmaceutical labelling

  • 1. 6-2
  • 2. Raw materials Final product It is complete but with lost identity………… processing
  • 3.
  • 4.
  • 5. Contents  What is Label? Need of a label Types of a label Manufacturer label Legal requirements Dispensing label 6-6
  • 6. LABEL “ Label means a display of written, printed or graphic matter upon immediate container or the wrapper of a drug package” 6-7
  • 7.
  • 8. TYPES OF LABEL Manufacturer label Dispensing label
  • 9. 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)
  • 10. 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
  • 11. 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” 6-12
  • 12. Brand Name: Brand name which is used to market the drug Property of drug company 6-13
  • 13. STRENGTH • It is amount of active drug per unit dose. • Example: amoxicillin 250mg capsules and amoxicillin 500mg capsules. 6-14
  • 15. DOSAGE FORM • Dosage form of the medicine should be mentioned on the label. e.g., • Different dosage forms of Amoxicillin
  • 16. QUANTITY Quantity /volume present per a packaging unitQuantity /volume present per a packaging unit The container hold 20 tablets and each tablet has a dosage strength of 500 mg per tablet. The container hold 20 tablets and each tablet has a dosage strength of 500 mg per tablet.
  • 18. Shake well before use: Necessary on all disperse systems: • Emusions • Suspensions e.g., Liniments Lotions Tinctures
  • 19. Warning!!!!! DO NOT SHAKE THE PATIENT, SHAKE THE BOTTLE WELL BEFORE USE……. 6-20
  • 21. Storage conditions Store in a cool place: 1. Not more than 0˚C-8˚C is necessary for many products
  • 22. Protect from light: Necessary for light sensitive preparations. Light resistive containers should be used.
  • 23. Keep out of the reach of children All dispensed medicines should carry this information on label
  • 24. 6-25
  • 26. Inflammable: If the preparation contain 50% or more alcohol or any other inflammable solvent, the label should contain word inflammable
  • 27. 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
  • 28. 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”
  • 29. 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. 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” 6-32
  • 32. 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
  • 35. Barcodes “It is an optical machine readable representation of data, which shows data about the object to which it attaches” 6-36
  • 37. It includes: Drug name and quantity Patient name Prescription number Phone number Instruction for use Pharmacy name and address 6-38
  • 38.
  • 40. Includes the information about: 1. Directions for use:  How to take a medicine 6-41
  • 41. EAR DROPS For external use only 2-42
  • 42. AEROSOLS INHALATIONS Pressurized containers keep away from heat source Shake before use Do not exceed the prescribed dose 6-43
  • 43. CREAMS For external use only Store in cool place
  • 44. 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
  • 45. REFERENCES: 1. Mannual of drug laws 2014 2. Dispensing for pharmaceutical students pharmacy by S.J Carter 6-46