description u.s. drug facts description opcon-a€¦ · putting drops in eye replace cap after use...

2
DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. EXP LOT DO NOT USE IF IMPRINTED NECKBAND IS NOT INTACT. 0.5 FL OZ (15 mL) www.bausch.com With antihistamine to relieve itching Original prescription strength Allergy When using this product overuse may cause more eye redness pupils may become enlarged temporarily do not touch tip of container to any surface to avoid contamination you may feel a brief tingling after putting drops in eye replace cap after use remove contact lenses before using Stop use and ask a doctor if you experience eye pain changes in vision redness or irritation of the eye that worsens or lasts more than 72 hours. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away. Accidental oral ingestion in infants and children may lead to coma and marked reduction in body temperature. Directions Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily. Children under 6 years: ask a doctor Other information store at 20°-25°C (68°- 77°F) protect from light Drug Facts (continued) Bausch & Lomb and Opcon-A are registered trademarks of Bausch & Lomb Incorporated © Bausch & Lomb Incorporated Rochester, NY 14609 100% SATISFACTION GUARANTEED. See inside of carton for details. Order No. 622090 Questions or Comments? Toll Free Product Information Call: 1-800-553-5340 3 6 10119 02090 Opcon-A ® PHENIRAMINE MALEATE 0.315% AND NAPHAZOLINE HYDROCHLORIDE 0.02675% OPHTHALMIC SOLUTION ITCHING AND REDNESS RELIEVER EYE DROPS Opcon-A ® PHENIRAMINE MALEATE 0.315% AND NAPHAZOLINE HYDROCHLORIDE 0.02675% OPHTHALMIC SOLUTION ITCHING AND REDNESS RELIEVER EYE DROPS Drug Facts Active Purpose ingredients Naphazoline HCI Redness (0.02675%)...........reliever Pheniramine maleate (0.315%).....Antihistamine Uses temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander. Warnings Do not use if you are sensitive to any ingredient in this product if solution changes color or becomes cloudy Ask a doctor before use if you have heart disease high blood pressure trouble urinating due to an enlarged prostate gland narrow angle glaucoma Drug Facts (continued) use before expiration date marked on the carton or bottle Inactive ingredients benzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride

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Page 1: DESCRIPTION U.S. Drug Facts DESCRIPTION Opcon-A€¦ · putting drops in eye replace cap after use remove contact lenses before using Stop use and ask a doctor if you experience eye

DO NOT USE IFIMPRINTED NECKBAND

IS NOT INTACT.

EXP

LOT

DO NOT USE IFIMPRINTED NECKBAND

IS NOT INTACT.

0.5 FL OZ (15 mL)

www.bausch.com

With antihistamineto relieve itchingOriginal prescriptionstrength

Allergy

When using this product■ overuse may cause more eye redness ■ pupils may become enlarged temporarily■ do not touch tip of container to any surface to avoid contamination■ you may feel a brief tingling after putting drops in eye■ replace cap after use■ remove contact lenses before using

Stop use and ask a doctor if you experience ■ eye pain ■ changes in vision■ redness or irritation of the eye that worsens or lasts more than 72 hours.Keep out of reach of children.If swallowed, get medical help or contacta Poison Control Center right away.Accidental oral ingestion in infants andchildren may lead to coma and markedreduction in body temperature.

Directions ■ Adults and children 6 years of age and older: Instill 1 or 2 drops in the affected eye(s) up to 4 times daily. ■ Children under 6 years: ask a doctor

Other information■ store at 20°-25°C (68°- 77°F) ■ protect from light

Drug Facts (continued)

Bausch & Lomb and Opcon-A areregistered trademarks of Bausch &Lomb Incorporated© Bausch & Lomb Incorporated Rochester, NY 14609

100%SATISFACTION GUARANTEED. See inside ofcarton for details.

Order No. 622090

Questions or Comments? Toll Free Product Information Call: 1-800-553-5340

36

1011902090

Opcon-A®

PHENIRAMINE MALEATE 0.315% AND NAPHAZOLINEHYDROCHLORIDE 0.02675% OPHTHALMIC SOLUTIONITCHING AND REDNESS RELIEVER EYE DROPS

Opco

n-A®

PHEN

IRAMI

NE M

ALEA

TE 0.

315%

AND

NAP

HAZO

LINE

HYDR

OCHL

ORID

E 0.02

675%

OPH

THAL

MIC S

OLUT

ION

ITCHI

NG AN

D RE

DNES

S REL

IEVER

EYE D

ROPS

Opcon-A®

PHENIRAMINE MALEATE 0.315% AND NAPHAZOLINEHYDROCHLORIDE 0.02675% OPHTHALMIC SOLUTIONITCHING AND REDNESS RELIEVER EYE DROPS

MOREINFORMATIONON INSIDE OF

CARTON.

MOREINFORMATIONON INSIDE OF

CARTON.

MOREINFORMATIONON INSIDE OF

CARTON.

MORE INFORMATIONON INSIDE OF

CARTON.

Sati

sfac

tion

Gua

rant

eed:

If y

ou’re

not

ful

ly s

atis

fied,

a f

ull r

efun

d w

ill b

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to:

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6300411

Drug FactsActive Purposeingredients NaphazolineHCI Redness(0.02675%)...........relieverPheniramine maleate(0.315%).....Antihistamine

Uses■ temporarily relieves itching and redness caused by pollen, ragweed, grass, animal hair and dander.

WarningsDo not use■ if you are sensitive to any ingredient in this product■ if solution changes color or becomes cloudy

Ask a doctor before useif you have■ heart disease■ high blood pressure■ trouble urinating due to an enlarged prostate gland ■ narrow angle glaucoma

Drug Facts (continued)

■ use before expiration date marked on the carton or bottle

Inactive ingredientsbenzalkonium chloride, boric acid, edetate disodium, hypromellose, purified water, sodium borate, sodium chloride

AW # 6300411

THIS COMPONENT PRINTS TWO SIDES THIS COMPONENT PRINTS TWO SIDES

1. Black

DESCRIPTION 15mL Opcon-A Itching & Redness Reliever Eye Drops Carton - U.S.

AW # 6300411

THE INFORMATION LISTED BELOW MUST APPEAR ON ALL VENDOR PROOFS (COLORKEYS, MATCHPRINTS/CHROMALINS) OR THEY WILL BE REJECTED

PLACED PICTURES:

SPEC. NO: 4010

PAGE 1 OF 2

PRINTED BAR CODES MUST BE VERIFIED READABLE AND ACCURATEBY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK

APPROVALS / DATE

PKG/GRPH

MKT/SALES

REG AFF

G. LEGAL

TM LEGAL

PT LEGAL

QA

DCO NUMBER

DATE

PMS COLORS PROCESS MATCH COLORS

SPECIAL INSTRUCTIONS

DIE LINE DOES NOT PRINT COATING PER SPECIFICATION

BAUSCH & LOMBGLOBAL GRAPHICS MANAGEMENT1400 NORTH GOODMAN STREETROCHESTER, NY 14609TEL: 585-338-5474FAX: 585-338-8959

Magenta prints 293

THE INFORMATION LISTED BELOW MUST APPEAR ON ALL VENDOR PROOFS (COLORKEYS, MATCHPRINTS/CHROMALINS) OR THEY WILL BE REJECTED

PLACED PICTURES:

SPEC. NO: 4010

PAGE 2 OF 2

PRINTED BAR CODES MUST BE VERIFIED READABLE AND ACCURATEBY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK

APPROVALS / DATE

PKG/GRPH

MKT/SALES

REG AFF

G. LEGAL

TM LEGAL

PT LEGAL

QA

DCO NUMBER

DATE

PMS COLORS PROCESS MATCH COLORS

SPECIAL INSTRUCTIONS

DIE LINE DOES NOT PRINT COATING PER SPECIFICATION

BAUSCH & LOMBGLOBAL GRAPHICS MANAGEMENT1400 NORTH GOODMAN STREETROCHESTER, NY 14609TEL: 585-338-5474FAX: 585-338-8959

1. PMS 3415C

2. PMS 293C

3. Process CyanC

4. PMS 235C

5. BLACK

DESCRIPTION 15mL Opcon-A Itching & Redness Reliever Eye Drops Carton - U.S.

micudaty
Text Box
Drug Facts - 14 point Helvetica Bold Italic Condensed Oblique Drug Facts - 8 point Helvetica Italic Bold Condensed Oblique (continued) - 8 point Helvetica Bold Condensed Oblique Headings - 8 point Helvetica Bold Italic Condensed Oblique Subheadings - 6 point Helvetica Bold Condensed Oblique Body Text - 6 point Helvetica Bold Condensed Oblique Bullets - 5 point square Boxline - 2.5 point Hairline - 0.5 point
Page 2: DESCRIPTION U.S. Drug Facts DESCRIPTION Opcon-A€¦ · putting drops in eye replace cap after use remove contact lenses before using Stop use and ask a doctor if you experience eye

Allergy

Allergy

Opcon-A®

PHENIRAMINE MALEATE 0.315% AND NAPHAZOLINEHYDROCHLORIDE 0.02675% OPHTHALMIC SOLUTIONITCHING AND REDNESS RELIEVER EYE DROPS

0.5 FL OZ (15mL)6300309

ACTI

VE IN

GRED

IENT

S: N

apha

zolin

e HCI

(0.0

2675

%),

Phen

iram

ine m

aleat

e (0.

315%

).US

ES: T

empo

raril

y reli

eves

itch

ing

and

redn

ess c

ause

d by

po

llen,

ragw

eed,

gra

ss, a

nim

al ha

ir an

d da

nder.

DIRE

CTIO

NS: A

dults

and

child

ren

6 ye

ars o

f age

and

old

er:

Inst

ill 1

or 2

dro

ps in

the a

ffect

ed ey

e(s)

up

to 4

tim

es d

aily.

Child

ren

unde

r 6 ye

ars:

Ask a

doc

tor

WAR

NING

S: If

you

expe

rienc

e eye

pain

, cha

nges

in vi

sion,

co

ntin

ued

redn

ess o

r irri

tatio

n of

the e

ye, o

r if t

he co

nditio

n wo

rsen

s or p

ersis

ts fo

r mor

e tha

n 72

hou

rs, d

iscon

tinue

use

an

d co

nsul

t a p

hysic

ian. D

o no

t use

in ch

ildre

n un

der 6

ye

ars o

f age

unl

ess d

irect

ed b

y a p

hysic

ian. I

f thi

s sol

utio

n ch

ange

s col

or o

r bec

omes

clou

dy, d

o no

t use

. Ove

ruse

of

this

prod

uct m

ay p

rodu

ce in

crea

sed

redn

ess o

f the

eye.

Keep

out

of r

each

of c

hild

ren.

REM

OVE

CONT

ACT

LENS

ES B

EFOR

E US

ING.

See c

arto

n fo

r add

ition

al W

ARNI

NGS.

Stor

e at 2

0°-2

5°C

(68°

-77°

F). P

rote

ct fr

om lig

ht.

To

ll Fr

ee P

rodu

ct In

form

atio

n Ca

ll: 1

-800

-553

-534

0Ba

usch

& L

omb

and

Opco

n-A

are r

egist

ered

trade

mar

ks o

f Bau

sch

& Lo

mb

Inco

rpor

ated

. ©

Bau

sch

& Lo

mb

Inco

rpor

ated

Baus

ch &

Lom

b, R

oche

ster,

NY

1460

9

DO

NO

T U

SE

IF

IM

PR

INTE

DN

EC

KB

AN

D IS

NO

T IN

TAC

T.

Opcon-A®

PHENIRAMINE MALEATE 0.315% AND NAPHAZOLINEHYDROCHLORIDE 0.02675% OPHTHALMIC SOLUTIONITCHING AND REDNESS RELIEVER EYE DROPS

0.5 FL OZ (15mL)

6300309

ACTI

VE IN

GRED

IENT

S: N

apha

zolin

e HCI

(0.0

2675

%),

Phen

iram

ine m

aleat

e (0.

315%

).US

ES: T

empo

raril

y reli

eves

itch

ing

and

redn

ess c

ause

d by

po

llen,

ragw

eed,

gra

ss, a

nim

al ha

ir an

d da

nder.

DIRE

CTIO

NS: A

dults

and

child

ren

6 ye

ars o

f age

and

old

er:

Inst

ill 1

or 2

dro

ps in

the a

ffect

ed ey

e(s)

up

to 4

tim

es d

aily.

Child

ren

unde

r 6 ye

ars:

Ask a

doc

tor

WAR

NING

S: If

you

expe

rienc

e eye

pain

, cha

nges

in vi

sion,

co

ntin

ued

redn

ess o

r irri

tatio

n of

the e

ye, o

r if t

he co

nditio

n wo

rsen

s or p

ersis

ts fo

r mor

e tha

n 72

hou

rs, d

iscon

tinue

use

an

d co

nsul

t a p

hysic

ian. D

o no

t use

in ch

ildre

n un

der 6

ye

ars o

f age

unl

ess d

irect

ed b

y a p

hysic

ian. I

f thi

s sol

utio

n ch

ange

s col

or o

r bec

omes

clou

dy, d

o no

t use

. Ove

ruse

of

this

prod

uct m

ay p

rodu

ce in

crea

sed

redn

ess o

f the

eye.

Keep

out

of r

each

of c

hild

ren.

REM

OVE

CONT

ACT

LENS

ES B

EFOR

E US

ING.

See c

arto

n fo

r add

ition

al W

ARNI

NGS.

Stor

e at 2

0°-2

5°C

(68°

-77°

F). P

rote

ct fr

om lig

ht.

To

ll Fr

ee P

rodu

ct In

form

atio

n Ca

ll: 1

-800

-553

-534

0Ba

usch

& L

omb

and

Opco

n-A

are r

egist

ered

trade

mar

ks o

f Bau

sch

& Lo

mb

Inco

rpor

ated

. ©

Bau

sch

& Lo

mb

Inco

rpor

ated

Baus

ch &

Lom

b, R

oche

ster,

NY

1460

9

DO

NO

T U

SE

IF

IM

PR

INTE

DN

EC

KB

AN

D IS

NO

T IN

TAC

T.

100%

200%

1. PMS 3415C

2. PMS 293C

3. Process CyanC

4. PMS 235C

5. BLACK

AW # 6300309

THE INFORMATION LISTED BELOW MUST APPEAR ON ALL VENDOR PROOFS (COLORKEYS, MATCHPRINTS/CHROMALINS) OR THEY WILL BE REJECTED

PLACED PICTURES:

SPEC. NO: 4017

PAGE 1 OF 1

PRINTED BAR CODES MUST BE VERIFIED READABLE AND ACCURATEBY VENDOR TO THE HUMAN READABLE INDICATED ON ARTWORK

APPROVALS / DATE

PKG/GRPH

MKT/SALES

REG AFF

G. LEGAL

TM LEGAL

PT LEGAL

QA

DCO NUMBER

DATE

PMS COLORS PROCESS MATCH COLORS

SPECIAL INSTRUCTIONS

DIE LINE DOES NOT PRINT COATING PER SPECIFICATION

BAUSCH & LOMBGLOBAL GRAPHICS MANAGEMENT1400 NORTH GOODMAN STREETROCHESTER, NY 14609TEL: 585-338-5474FAX: 585-338-8959

DESCRIPTION 15mL Opcon-A Itching & Redness Reliever Eye Drops Label - U.S.