Pharmaceutical labelling

AKSON COLLEGE OF HEALTH SCIENCES MIRPUR AJK 6-1

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Raw materials Final product

It is complete but with lost identity…………

I am complete but with lost identity…………

processing

Contents What is Label?Need of a labelTypes of a labelManufacturer labelLegal requirementsDispensing label

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LABEL “ Label means a display of written, printed or graphic

matter upon immediate container or the wrapper of a drug package”

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TYPES OF LABELManufacturer labelDispensing 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 preparation2. 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. Price10.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”

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Brand Name:

Brand name which is used to market the drugProperty of drug company

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STRENGTH• It is amount of active drug per unit dose.

• Example: amoxicillin 250mg capsules and amoxicillin 500mg capsules.

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SPECIFICATION

U.S.PB.P

DOSAGE FORM• Dosage form of the medicine should be mentioned on

the label. e.g.,• Different dosage forms of Amoxicillin

QUANTITYQuantity /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…….

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Precautions

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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 childrenAll dispensed medicines should carry this information

on label

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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 substancesAbout combining with other drugs or products

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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 numberAcc. 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

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Expiry dateAccorrding 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”

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Liscense numberBiological 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 informationNameAdress

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Price

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Barcodes“It is an optical machine readable representation of

data, which shows data about the object to which it attaches”

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McGraw-Hill 6-37

It includes:Drug name and quantityPatient namePrescription numberPhone numberInstruction for usePharmacy name and

address

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McGraw-Hill 6-40

Includes the information about:

1. Directions for use:

How to take a medicine

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EAR DROPS

For external use only

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AEROSOLS INHALATIONSPressurized containers

keep away from heat source

Shake before useDo not exceed the

prescribed dose

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CREAMSFor external use onlyStore 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

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