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Pharmaceutical labelling

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Pharmaceutical labelling
Pharmaceutical labelling
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Pharmaceutical labelling

  1. 1. AKSON COLLEGE OF HEALTH SCIENCES MIRPUR AJK 6-1
  2. 2. 6-2
  3. 3. Raw materials Final product It is complete but with lost identity………… processing
  4. 4. Contents  What is Label? Need of a label Types of a label Manufacturer label Legal requirements Dispensing label 6-6
  5. 5. LABEL “ Label means a display of written, printed or graphic matter upon immediate container or the wrapper of a drug package” 6-7
  6. 6. TYPES OF LABEL Manufacturer label Dispensing label
  7. 7. 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)
  8. 8. 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
  9. 9. 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
  10. 10. Brand Name: Brand name which is used to market the drug Property of drug company 6-13
  11. 11. STRENGTH • It is amount of active drug per unit dose. • Example: amoxicillin 250mg capsules and amoxicillin 500mg capsules. 6-14
  12. 12. SPECIFICATION U.S.P B.P
  13. 13. DOSAGE FORM • Dosage form of the medicine should be mentioned on the label. e.g., • Different dosage forms of Amoxicillin
  14. 14. 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.
  15. 15. INSTRUCTIONS
  16. 16. Shake well before use: Necessary on all disperse systems: • Emusions • Suspensions e.g., Liniments Lotions Tinctures
  17. 17. Warning!!!!! DO NOT SHAKE THE PATIENT, SHAKE THE BOTTLE WELL BEFORE USE……. 6-20
  18. 18. Precautions 6-21
  19. 19. Storage conditions Store in a cool place: 1. Not more than 0˚C-8˚C is necessary for many products
  20. 20. Protect from light: Necessary for light sensitive preparations. Light resistive containers should be used.
  21. 21. Keep out of the reach of children All dispensed medicines should carry this information on label
  22. 22. 6-25
  23. 23. For external use only:
  24. 24. Inflammable: If the preparation contain 50% or more alcohol or any other inflammable solvent, the label should contain word inflammable
  25. 25. 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
  26. 26. 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”
  27. 27. 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”
  28. 28. Manufacturing date 6-31
  29. 29. 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
  30. 30. 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
  31. 31. Manufacturer information Name Adress 6-34
  32. 32. Price 6-35
  33. 33. Barcodes “It is an optical machine readable representation of data, which shows data about the object to which it attaches” 6-36
  34. 34. McGraw-Hill 6-37
  35. 35. It includes: Drug name and quantity Patient name Prescription number Phone number Instruction for use Pharmacy name and address 6-38
  36. 36. McGraw-Hill 6-40
  37. 37. Includes the information about: 1. Directions for use:  How to take a medicine 6-41
  38. 38. EAR DROPS For external use only 2-42
  39. 39. AEROSOLS INHALATIONS Pressurized containers keep away from heat source Shake before use Do not exceed the prescribed dose 6-43
  40. 40. CREAMS For external use only Store in cool place
  41. 41. 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
  42. 42. REFERENCES: 1. Mannual of drug laws 2014 2. Dispensing for pharmaceutical students pharmacy by S.J Carter 6-46

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