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Pharmaceutical labelling

This document discusses labels for pharmaceutical products. It defines a label and describes two main types - manufacturer labels and dispensing labels. Manufacturer labels contain drug information for medical professionals and must include the name, strength, dosage form, quantity, instructions, precautions, registration number, batch number, dates and manufacturer details. Dispensing labels are affixed by pharmacists and include the patient's name, prescription number, directions for use, pharmacy information and sometimes interactions. Labels provide important information to ensure drugs are used safely and effectively.

Health & Medicine◦
AKSON COLLEGE OF HEALTH SCIENCES MIRPUR AJK 6-1
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