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Labelling

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Dr. Deepak Chitkara
BITS-Pilani
LABELS ON DISPENSED MEDICINES
I.P. 2007
Label means any printed packaging material, including
package inserts that provide information on the article.

U.S.P, 30
The term LABELLING designates all labels and other
written, printed or graphic matter upon an immediate
container of an article or upon, or in, any package or
wrapper in which it is enclosed, except any outer
shipping container. The term label designates that part 2

of labelling upon the immediate container.


MISBRANDED DRUGS
A drug / cosmetic is deemed to be Misbranded
if it is not labelled in the prescribed manner.
if its label or container or anything accompanying the
drug bears any statement, design or device which makes
any false claim for the drug or which is false or misleading
in any particular.

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LABELS ON DISPENSED MEDICINES
Give the patients complete and clear instructions
on how to take or use the preparation
Indicate the storage conditions, necessary to
ensure full potency throughout the period of
treatment
Be neatly written and carefully displayed on the
container

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INFORMATION
Required by law- The D & C Act,1940 and
Rules 1945
Necessary for pharmaceutical reasons
To indicate restrictions on the use of the
preparation
To give special instruction on the method
of use
To specify storage conditions and shelf life
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CONTENTS OF A LABEL
The name of the drug (proper name,
conspicuously, and brand name, if any)- inclusion
of the letters, I.P, NFI, B.P, USP, or descriptive of
the true nature or origin ( generic name)
The Net Contents,
The contents of active ingredients,
The name & address of the manufacturer,
Batch Number
Manufacturing license number
Date of manufacture & the date of expiry of
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potency
CONTENTS OF A LABEL
Import licence number
Physician's sample Not to be sold,
Percentage of Alcohol, if not less than 3%,
Red vertical line - of not less than 1mm
thickness, (falling under schedule G,H,X,
narcotic analgesics, hypnotics, sedatives,
tranquilizers, corticosteroids, hormones,
hypoglycemics, antimicrobials,
antiepileptics, anticancer drugs)
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CONTENTS

OF A LABEL
Schedule G drug Caution: it is dangerous to take this
preparation except under medical supervision - conspicuously
printed, - surrounded by a line, -no other words.
Schedule H drug - Rx on the left top corner conspicuously
Schedule H drug warning: to be sold by retail on the
prescription of a Registered Medical Practitioner only
Schedule H drug falling under THE NARCOTIC DRUGS AND
PSYCHOTROPIC SUBSTANCES ACT, 1985 (NDPS Act, 1985) -
NRx ,in red color ,on the left top corner ,conspicuously Schedule
H drug warning: to be sold by retail on the prescription of a
Registered Medical Practitioner only
Schedule X drug warning: to be sold by retail on the
prescription of a Registered Medical Practitioner only. 8
ADDITIONAL INFORMATION
1. For external use only Eg. Liniments

2. Not to be taken

If for veterinary use Not for human


use ; for animal treatment only

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ADDITIONAL INFORMATION
Restricting use of preparation
1. For external use only
2. Not to be taken
Liquid preparations that are not administered by
mouth or used on the skin
Nasal drops, nasal sprays and enemas
Pessaries, suppositories and vitrellae
Solution tablets used to prepare disinfectants and
antiseptic solutions
For nasal use only

For rectal se only 10

For vaginal use only


ADDITIONAL INFORMATION
Instruction for using the preparation

1. Shake the bottle

2. Special instructions
Cachets- To be immersed in water for a few seconds, placed on the
tongue and swallowed with a draught of water
Dusting powders- Not to be applied on open wounds or to raw or
weeping surfaces
Enemas- To be warmed to body temperature before use
Gargles and mouthwashes- Directions for dilution, not to be taken,
Not to be swallowed in large amounts
Inhalations- Add one teaspoonful to a pint of hot , not boiling,
water and inhale the vapour
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Insuffalations and sprays- To be used in a suitable atomizer as
directed
ADDITIONAL INFORMATION
Storage conditions
1. Store in a cool place
2. Protect from light
3. Inflammable
Protection from children

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Volume
Preparation Name and strength
(Use)
Dispensed By: PRODUCT NAME License No.:
Patient Name: Batch no.:
Directions for use: (Dose and Composition: Mfg. Date:
dosage) Expiry Date:
Instructions (In red ink): MRP: Rs. XX (Inclusive of
all taxes)

Mfg. By: Pharmacy name with complete address

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Agitation treatment in elderly
dementia patients
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