PHARMACEUTICAL LABELING OF DRUGS PRECTICAL CLASS

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 Name of preparation Strength and dosage form Specification Quantity Instructions for the use Precautions & warnings Manufacturing licence number Batch number Manufacturing & Expiry date Price 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. Registration number “A number given to a specific drug when it is registered according to specific rules by registration board of government”

25. 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

26. Manufacturing date

27. 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

28. Price

29. Manufacturer information Name & Address

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

31. Labeling

32. SPECIAL INSTRUCTIONS

33. Includes the information about: 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.: Amine containing foods (tyrosine) with monoamine oxidase inhibitors ( hypertensive crisis ) 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