Information regards label and special indications on label And other special label requirements

1. MAHARSHI DAYANANDD
UNIVERSITY
DEPARTMENT OF PHARMCEUTICAL SCIENCES
PHARMACEUTICAL JURISPRUDENCE
THEORY ASSIGNMENT OBJECTIVE:
Labelling and special labelling requirements
Session: 2021-2022
Submitted to
Dr. Arun Nanda
Professor Submitted by
Dheeraj
B.Pharm. 5th semester
Roll no. 1431

2. A labels of a dsug ghould wnkermay pe1 the speuipicaber
*labeluny n ndua.
undey the deuss and teime tica Rule , 1945.
No Persbn
lakelladin atomdanu with he Pull Rulu qS DC At)
Sell dstbte anydauus unly itts
Ompertanu
The sake wi c l meditnis dcpends en woy
HLadins the labeluny and packaqng Caneally and
acCtatt ly and being ale to assimilak and at en the
tnemahon puko kd.
eAl lakel mut be claas and Con ue and mut
All
beo al necessay inoimahbn Rsganding uu
h
so e a produtt.

3. Speciallabelling Requrements
label
Eabel maans any unitten, painted os paphiè mattey en the
tmmeeu
ate package and on eveu otthey Coveung in whth the
fackea is plaed e packad and includes any wrutten, paelnk
9aphic mattey accompanying the nse tticidle
(Onsecbcicls Act, (066).
label muans any teq, btand,motk, prctorial on athH
dasouptrve mattel, wuten, paunted, s knuiled, mankd
embesse Praphic, peleiakd, skemped e impacsedl en er
atachedto conteuiney, Cove, uid on eOwn of any kodpatkoq
and incleudas a pruoduct fnaut (The feoel ane saty standata
Act, oo6)
abel means any prnled packaging matuual, incduding
fackoq insent that ppuoujdes inketmaben en the arhcle.
(T.P.20ot)
label s a builge betwEn he pocuay and tontume het
tlenhichien o produt, ta tonknt, deags keum, Produos
ham and othey indicahens.
*Genvnal labelung Requiuments
The tonkahey o all the dsuuss Ialuding Patent e puoprulekay
medt cin ont to be labe llac tn accetdane with the dsuus and
Cesmetics eulu,1945
Followinq foticulas should bee+hey PHinkd weutkn in
indelible ink and should appar ina lenspicuoul mannet
en the abel o the innemost tonkuney a any doug and on evexy

4. othyoveungs în whsch the tonuinen i packed.
1. Puopo name dug should be pounkd h a moe tonspichous
MAnnthan the tede name, '5 A
. A ceect stakment of the nut tenktnt in teimi o weughi,
mealu, Volumt, numbn units q Activih, al the tase may
be, al erprked in mebui Lystem.
3 he tontnt o Ackive ingoudienks-
(a) Fet cal iquid preparatiens in tems o the onknt pet Sing
dOs lt. Sml o mulhple thenee. wheu the dose îu beloo Sml the
Conknts o achu ingpuditnts may be ekpruted ntuumt of one
m en
kachen thwue
fe uqud puepaabnu neady hen adminiatrabens, in tim e
(b
1 m e pauntage by valume e1 peH dece in the tase e a dingle
dose lontaineu. the pripaabons ae Contcune in an
dose
aoLle th tompeci hon m be ghoon on the abel ei wappes
ied to any packag in hih such ampeule i îuseued fee
Fo dougs in selid feam tntndud e parinteral adminv-
trahon in tuumi ounita er. weighnt pay mg en ramm.
)For tahuts, tapguluy, pilk ete. in korm o the tonkns in eacbh
fer
unut.
ey Festhey paupanadonu, n tem o pe1Ctndeq by we4ht
e volume e to Oim o uVu tz pey gam el ml.
fHovide thot nothih untei(3) abeoue applies to 1hepharmatopeic
frLpaatonu hee the comfosihon such puparatins sPeccd

5. in bhe nupective pheumatopeia ard ba pruparaben induded
tn the Mespechve
tn the Nahonal Fonmulany o Jndia. (NET)
the
4The name and addrus of manufractwe Jn caieofhe douu
Contcun tn an ampoule ol a smilay 6mall wntuine it i
enough oly the name the manu{tacluuinand hù punupe
5
Panufmactuu lttna Numbey et nfq lic Ne or
M
6. A distin chve bateh Numbey the Hwu sapusenhing the bakch Numbay
place o business au shown.
buiny Pudrd by the wedsBceh No'o l8 No' Batch e lotNe'
eylot
The label o ionemest tontaney o th follouwy takpve4 ods
and evey other coURung n ohich the tontuine packed shall
bea a Conspic ouk Hd veshtal ine en the lkt aide nunnin
tvoghout the boeby o the label without distujbing thu othe
Prunkt tond hent en the label
Nauto tics, Analgsitd, Hypnobcs, átdabve, taanquiluaed,
Cettosto ies Hermenzi, typely Cemics, Anhim eobialu, And-
epiupts, An daprubarts, hnticodgulanta , Anhi- Canay dvug
othey duuyunduySchyle 4, H, x.
These PHDUI6)erd hall not apply to
hese
Ca) ppavatns inttndlind fet anlmal tuaatmint omasknal
S) Opthalmc poupaabint and ear dhops'
c) Prupanain indendd te pantnt eral ue and skie
paeponatons suey o sutuLs dungical dousS/ngs.

6. Mfg. Lic. No.: KD 656
Composition:
Each 5 ml contains:
Bromhexine Hydrochioride P Amg
Salbutamol Sulphate
Eq. to Salbutamol
Colour: Sunset Yellow
Bromhexine Hydrochloride Batch No. 9P42102
Mfg. Date:
Exp. Date
with Salbutamol
sulphate Syrup
05/2019
04/2021
IP
2 mg
Cough ExpectorentSyrup
100 ml
Dosage: As directed by the Physician. Manufactured in India by:
HARYANA GOVT. SUPPLY
NOT FOR SALE Ciron Drugs
Storage: Store in a cool dark place.
Protect from light. SCHEDULE H PRESCRIPTION
DRUG-CAUTION
Not tobe sold byetainithoLt
theprescription of a Registered
Medical Practitioner
&Pharmaceuticals Pvt.Ltd.
Plot No.35 to 37,43 to 45,
CFC-B, Dewan Udyog Nagar,
Aliyali, Palghar,
Dist. Palghar - 401 404.
www.cironpharma.com
Keep out of reach of children.
SHAKE WELL BEFORE USE.

7. 3. txpinay peutiuulars
fu taudinau inheriiaben krlatd to lart in handug, we
Aztuibuton etc
lo-
nemahin Rlatedto stsge on manney ot
uenval infeimahon sueh as
fhysiuan' Sampl, not ken Saliet.
*Spetial labellung. Paruhiula
Scheduu C
Date cmanu actu
Da E<piy
mpot ltenu Numbet,i appliable.
Schedul E, f
The puesoubd Name.
schdul G
Jt us dangeious to taketh pupaHadon extapt unden
Caulion.
medital SupeNiston, be
Conspiquously prunkol and gwvundsd
Line within tohich thou ahould be no othe weds
Schedule H
(Medicinu madt up HLady feu intonal use
o Human bungs)
Symbol conspicuoyly displayd en the lht top cetney of label.
Schdsu H Duu -
wan To be solet bq Hetaulon the
.
pbiphon o a
Rgustvud mdial Puacttioneony
Fallng undu Danqeous Duugs At, 930
Symbol N tonspicuDLwly displayu on thu bkt top eneyotlebe
Schedul H Du9 -Loaminq To be sold be Hetail on the
Pytuphon ota Rgistu madtal frectihioney on

8. Schedul x
mediune mads up nta ken intunal use o Human beinas)
nbol N in nad, tonspicuotusy diplace4n ut bop eU 5 the lecbe
Sehedu le X Dauas -
wannirg: To be sold by Hetatl on the Paegu4pten
a
Ragistoud medial Prachibone on.
Bulk kem)
Smbo X qiven tokpicuo ugy tn Red.
SchedueP
Date ok manuhnacwe
Dak o Erpiny " the pokncy.
Sehadule C
PRop hame o the subsBantu in addihen to any patnt e
d
LO pietaj name.
cense NO. undeyuhthmanuachuwue impet
Batch No. e lot No.
Statmtnt o pokny in unu, what evy uq uinod by the Rulus.
Namt and addsus he manu{aetuwy nal piocluct.
Dak manuHacuu
6a test fe maximum toxi pesybed, a statment thatthe
dug has paujsed the tst.
Dak o RPIPLwhaevey presberl.
Nahu- and peyuntaae e ibephc added, i any
PAR Cauhon neC?4gasuy PpustValng tho
Puo pethes o dug.
faknt and pro pietas wntaning vitamin (1 p*o phsachcuwe.
Fo Popkylachic uwe
Fey herapeuhic we.

9. NUN Suial ligatue and Sutu
Co Non- S toule .Srqal ligaua (suhue) hot fb be. wed
Optatiens upon the human boctyunus Huently steulsed
Pnted tons piumouyu in indelible md in k.
tloholc puepamabong
Stakmtnt o bu quahity f Alchol as await e absoluk
Alwhel by volume
fupaahins or Extnal use.
FOR ExTERNAL USE ONLY
Ophthalouic fseepanabòng
Spe cieu tnsbuntans egadnsto-ag1, whewver applu able
bnh ioutahon peuistsen thorease disconhnu the
we and tengult thu phyaiuan.
Disincteinb
lame of thu puoeduct and name and addHuss o manukyachuww.
G1Hade, type and Ridual walkey to{titent o Pouoduct.
Dat , manufeiachune and dak ue to tohih it tan be wed.
Quan th, in the tontaine
naitahen and mol use.
Mechanica lonttapfives
Panicularu dpecizied n SchaduluR
Dak manuaaehwu and dak tupto uwhjch it îs cxpetkd
Dat
to Rutaun its pao peHeJ.
Stona ondihons

10. PhasAmaLo poeal, and othes
Name e1
Snonym as specited in the Phauma topoeia folloe
by the
lettey l7p' 'gP 'usP' 'NE'etc. as the Cose may be,
desdes otphon the SulstonLe
ywvedc. midiine"en Siddha meds'une "enUnani
mediuu. o Homeo pahic mediune" as the Case ma be
The

11. Relonencu.
aun N.k., A Tstbook oFeHensic Phaumay,3 tdihon,
Jatn N
Valabh Prakahan, tanu Ne- 134-66, I7o,
dChedule 9, qood manulacwung pa tbus and Requnements
Pumsu plant and equpment key fhamatuial
Pocduca, Gazutte o{ Sndit, ExtaaPidinay, Part-1, U
AAma K, fuqushoth T., Pakt| k, Phaima uuhal Jwuspueun
Thakw fublttation Pvt ltd, edihon ol1, fass No-66-to
DSS, Chwuyuu1, R., A kstbeok o fhauma euubcal
Jwuis prudent NiHali Prakeshan aduancuml o
Knaleda, 1edhon,Aug 2o l9, fani No 2-20- 2.24.