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Labeling and Packing of Drugs

All containers of drugs & medicines are labeled as
per D & C Act.

Following particulars should appear on label of inner
most containers of any drug & on every other
covering in which container is packed .

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Manner of Labeling
Labeling of drugs manufactured for sale:

1. Name of the drug.

Proper name or

Official name or synonym specified in pharmacopoeia.

Ex: Analgin Tablets IP
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For new drug , containing single active ingredient or a
preparation containing single active ingredients
specified in schedule W , generic name but not trade
name
ex: Ferrous sulphate tablets

Manner of Labeling
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2. The net content:

Weight in gram (solid, semi-solid)

Volume in ml (liquids)

Units in number (unit dosage forms Tablets , capsules)



Manner of Labeling
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Contents of active ingredients in single dose or in 5ml
or in 1ml or in one unit or in percentage

Name & address of manufacturer

Batch No or lot No

Manufacturing license number/mfg .Lic .No / M.L No.

Manner of Labeling
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Date of manufacture / Mfg .dt.

Date of expiry for preparations as per schedule P or
life period of drugs

Import license number for imported preparation
containing schedule C1 drugs

Manner of Labeling
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Physicians sample, not to be sold for free sample
distribute to the medical professional

The quantity of alcohol as average percentage by volume
of absolute alcohol, if the preparation contains more then
3% alcohol
Manner of Labeling
8
For single use only for mechanical contraceptives

Retail price not to exceed Rs------ + local taxes extra/
inclusive of all taxes

The drug for internal use containing schedule G
Drugs labelled with the words

Caution : it is dangerous to take this preparation
except under medical supervision
Manner of Labeling
9
The drug for internal use ,containing schedule H
substances labelled with symbol Rx on left top corner
of label and with the following words

Schedule H drug:
Warning : To be sold by retail on prescriptions of RMP
only
Manner of Labeling
10
Drugs for internal use containing schedule H which
comes under control of the Narcotic drugs & psychotropic
substances Act(1985) labelled with symbol NRx in red on
left top corner of the label & following words

Schedule H drug: to be sold by retail on the prescription of
a RMP only

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The drugs for internal use ,containing schedule X
substance labelled with symbol XRx red on left top
corner of label and with the following words

Schedule X drug: to be sold by retail on the prescription
of a RMP only
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The preparation used as liniment, lotion, liquid antiseptic
or other liquid medicine for external use shall be labeled
with words in capital FOR EXTERNAL USE ONLY

The drugs for animal treatment shall be labeled with
words Not for human use for animal treatment only
and with symbol of the head of an animal.
Manner of Labeling
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The drugs containing industrial methylated spirit for
human treatment shall be labelled with words
FOR EXTERNAL USE ONLY

Non sterile surgical ligature & suture should be
labelled with words in Red

Non sterile surgical ligature & suture not to be used
for operation upon the human body unless efficiently
sterilized
Manner of Labeling
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Manner of Labeling
Ophthalmic solutions / suspensions / ointments need to
contain the following contents
Use within one month of opening. Not for injection
Name and concentration of preservative
Caution: if irritation persists or increases discontinue use
and consult physician.
Keep container tightly closed
Do not touch the dropper tip/other dispensing tip to any
surface since this may contaminate the preparation
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Labeling of drugs for export
Label shall meet the requirement of law of the country
to which the drug to be exported

Particulars: shall also appear on the label

Name of the drug

Name & address of the manufacturer
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Manufacturing licence number

Batch number

Date of expiry

The words FOR EXPORT ONLY shall be made on the
label

Labeling of drugs for export