PHARMACEUTICAL LABELING OF DRUGS MBBS, BDS, BPT, B & D PHARMA CLASS

1. PHARMACEUTICAL LABELING
By
Dr. Manoj Kumar Assistant Professor
Department of Pharmacology Adesh
Medical College & Hospital Ambala Can’t

2. LABEL
Label means a display of written, printed or graphic matter
on the wrapper of a drug package

3. TYPES OF LABEL
 Manufacturer label
 Dispensing label

4. Manufacturer label
 A label which contain drug information for the use of
medical practitioners, pharmacists, nurses supplied by the
manufacturer, packer or distributor of the drug

5. LEGAL REQUIRMENTS OF A MANUFACTURER LABEL
1. Name of preparation
2. Strength and dosage form
3. Specification
4. Quantity
5. Instructions for the use
6. Precautions & warnings
7. Manufacturing licence number
8. Batch number
9. Manufacturing & Expiry date
10. Price
11. Name & address of pharmaceutical company

6. NAME OF THE PREPARATION
Generic name:
 According to drug labeling and packaging rules 1986:
“ International non-proprietary name means the name of a
drug as recommended by WHO ”

7. Brand Name:
 Brand name which is used to market the drug
 Property of drug company

8. STRENGTH
 It is amount of active drug per unit dose
 E.g. Amoxicillin 250mg capsule, Amoxicillin 500mg capsule

9. SPECIFICATION
 USP
 BP
 IP

10. DOSAGE FORM
 Dosage form of the medicine should be mentioned on the
label
 e.g. Different dosage forms of Amoxicillin

11. QUANTITY
 Quantity /volume present per one packaging unit
 The container holds 20 tablets and each tablet has a dosage
strength of 500 mg per tablet
 Red line: running on left side of the label
throughout the body of label.
 Indicates that these cannot be purchased
without doctor’s prescription

12. INSTRUCTIONS

13. Shake well before use:
Necessary on all disperse systems:
• Emulsions
• Suspensions
• Liniments
• Lotions
• Tinctures

14.  Warning!!!!!
DO NOT SHAKE THE PATIENT,
SHAKE THE BOTTLE WELL BEFORE USE…….

15. Precautions
 .

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

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

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

19. WARNINGS
 .

20. Not to be taken:
 Liquid preparation that are not administered by mouth
For e.g. nasal drops, nasal sprays
 Unit dosage forms e.g. rectal suppositories
Types of warnings
 If hypersensitivity to a drug
About combining with other drugs or products

21. Use
For external use :
 .

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

23. Manufacturing License 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

24. Batch number
 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

25. Manufacturing date

26. Expiry date
 According 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

27. Price

28. Manufacturer information
 Name & Address

29. Barcodes/QR Code
 It is an optical machine readable representation of data,
which shows data about the object to which it attaches

30. Labeling

32. SPECIAL INSTRUCTIONS

33. Includes the information about:
1. Directions for use:
 How to take a medicine

34. EAR DROPS
 For external use only

35. AEROSOLS INHALATION
 Pressurized containers keep away from heat source
 Shake before use
 Do not exceed the prescribed
dose

36. CREAMS
 For external use only
 Store in cool place

37. Interactions
 Certain drugs may have serious reactions if taken along with
particular food or drugs
e.g.:
a) Amine containing foods (tyrosine) with monoamine
oxidase inhibitors (hypertensive crisis)
b) Tetracycline with milk

38. .
Dispensing
label

39. It includes:
 Patient name
 Prescription number
 Phone number
 Drug name and quantity
 Instruction for use
 Pharmacy name and address