(nsaid) - accessdata.fda.gov · recovering from chicken pox or flu like symptoms should not use...

Reye's syndrome: Children and teenagers who have or are recovering rom ch cken pox or flu like symptoms should not use this product.

When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Stomach bleeding warning: This product contains an NSAID, which may ause severe stomach bleeding. The chance is higher if you • are age 60

or older • have had stomach ulcers or bleeding problems • take a blood hinning (anticoagulant) or steroid drug • take other drugs contain ng

prescription or nonprescription NSAIDs (aspirin, ibuprofen, naproxen, or others) • have 3 or more alcoholic drinks every day while using this product • take more or for a longer time than directed

PEEL

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TO OPEN:Peel backpaperrom

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TO OPENPeel back

paperfrom

arrowAspirin Capsules, 325mg(NSAID)

EXPIRES: MM/DD/YYYY LOT#: 012345

PLx Pharma Inc.8285 El Rio, Suite 130 Houston, TX 77054

Aspirin Capsules, 325mg(NSAID)



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paperfrom

arrowAspirin Capsules, 325mg(NSAID)



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arrowAspirin Capsules, 325mg

(NSAID)EXPIRES: MM/DD/YYYY LOT#: 012345


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(NSAID)EXPIRES: MM/DD/YYYY LOT#: 012345





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EXPIRES: MM/DD/YYYY LOT#: 012345PLx Pharma Inc.

8285 El Rio, Suite 130 Houston, TX 77054

1G

1A

1C

1E

1F

Reference ID: 4296468

Pain Reliever/Fever Reducer (NSAID)Aspirin Capsules, 325 m

g

Pain Reliever/Fever Reducer (NSAID)Aspirin Capsules, 325 mg

7 Liquid-FilledCapsules

7 Liquid-FilledCapsules

NDC 00000-0000-0

7 Liquid-Filled Capsules


*Consult your healthcareprovider before using this

product for your heart.

Distributed by:PLx Pharma Inc.

8285 El Rio, Suite 130Houston, TX 77054

Visit us at: www.companyxxx.com

FPO

Aspirin (NSAID)* 325mg

*nonsteroidal antiinflammatory drug

• For the temporary relief of minor aches and pains associated with: • a cold • headache • backache • muscular aches • toothache • premenstrual & menstrual cramps • minor pain of arthritis • Temporarily reduces fever

Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flulike symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction which may include:• hives • facial swelling • shock • asthma (wheezing)This product contains soy.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:• are age 60 or older • have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]• have 3 or more alcoholic drinks every day while using this product• take more or for a longer time than directed

Do not use if you have ever had an allergic reaction to aspirin or any otherpain reliever/fever reducer.

Ask doctor before use if• stomach bleeding warning applies to you• you have a history of stomach problems, such as heartburn• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease• you are taking a diuretic• you have asthma

Ask doctor or pharmacist before use if you are• taking a prescription drug for diabetes, gout or arthritis

Stop use and ask a doctor if• an allergic reaction occurs. Seek medical help right away.• you are experiencing any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that doesn’t get better• pain gets worse or lasts more than 10 days• fever gets worse or lasts for more than 3 days • ringing in the ears or loss of hearing occurs• redness or swelling is present in the painful area• any new symptoms occur. These could be signs of a serious condition.

If pregnant or breastfeeding, ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

• drink a full glass of water with each dose• adults and children 12 years and over: • take 1 to 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist • do not exceed 12 capsules in 24 hour• children under 12 years: consult a doctor

• save carton for full directions and warnings• store at 1530°C (5986°F)• avoid excessive heat above 40°C (104°F)• do not use if the blue band around the capsule is missing or broken

anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C Blue #1, hypromellose, medium chain triglycerides, pharmaceutical ink, potassium chloride, soy lecithin, titanium dioxide

Call 18888423567 8:30 AM 4:00 PM ET, Monday Friday

Drug Facts (continued)

............................pain reliever/fever reducer

Drug Facts

Uses

Warnings

Directions

Other information

Inactive ingredients

Questions or comments

Active ingredient Purpose(in each capsule)


TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEALWITH REPEATED TEXT “SEALED FOR YOUR PROTECTION”UNDER CAP IS MISSING OR BROKEN.

RETAIN CARTON FOR COMPLETEWARNINGS AND INFORMATION

Area for

Lot & exp.FIRST LIQUID-

FILLED ASPIRINCAPSULES

325 mg


FPO

NDC 00000-0000-0





Pain

Rel

ieve

r/Fe

ver R

educ

er (N

SAID)

Aspi

rin C

apsu

les,

325

mg







FIRST LIQUID-FILLED ASPIRINCAPSULES

325 mg

Dist

ribut

ed b

y:PL

x Ph

arm

a In

c.

8285

El R

io, S

uite

130

Hous

ton,

TX

7705

4Vi

sit u

s at:

ww

w.co

mpa

nyxx

x.co

m


*nonsteroidal antiinflammatory drug


Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flulike symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction which may include:• hives • facial swelling • shock • asthma (wheezing)This product contains soy.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:• are age 60 or older • have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]• have 3 or more alcoholic drinks every day while using this product• take more or for a longer time than directed

Do not use if you have ever had an allergic reaction to aspirin or any otherpain reliever/fever reducer.

Ask doctor before use if• stomach bleeding warning applies to you• you have a history of stomach problems, such as heartburn

• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease• you are taking a diuretic• you have asthma


Stop use and ask a doctor if• an allergic reaction occurs. Seek medical help right away.• you are experiencing any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that doesn’t get better• pain gets worse or lasts more than 10 days• fever gets worse or lasts for more than 3 days• ringing in the ears or loss of hearing occurs• redness or swelling is present in the painful area• any new symptoms occur. These could be signs of a serious condition.

If pregnant or breastfeeding, ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away

• drink a full glass of water with each dose• adults and children 12 years and over: • take 1 or 2 capsules every 4 hours or 3 capsules every 6 hours while symptoms persist • do not exceed 12 capsules in 24 hours• children under 12 years: consult a doctor

• save carton for full directions and warnings• store at 1530°C (5986°F)• avoid excessive heat above 40°C (104°F)• do not use if the blue band around the capsule is missing or broken


.......................pain reliever/fever reducer

Drug FactsActive ingredient Purpose(in each capsule)

Uses

Warnings

Directions

Other information

anhydrous citric acid, carrageenan, colloidal silicon dioxide, FD&C Blue #1, hypromellose, medium chain triglycerides,pharmaceutical ink, potassium chloride, soy lecithin, titanium dioxide

Call 18888423567 8:30 AM 4:00 PM ET, Monday Friday



RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION


TAMP

ER EV

IDEN

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NOT

USE

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Area for

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*Consult your healthcare provider before using this product for your heart.


g N

DC - 1234-5678-90


LOT/EXP

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL WITH REPEATED TEXT

“SEALED FOR YOUR PROTECTION” UNDER CAP IS MISSING OR BROKEN.

Aspirin (NSAID)* 325mg*nonsteroidal anti inflammatory drug


Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

Allergy alert: Aspirin may cause a severe allergic reaction which may include: • hives • facial swelling • shock • asthma (wheezing)This product contains soy.

Continue Reading

Distributed By: PLx Pharma Inc.8285 El Rio, Suite 130 Houston, TX 77054

Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:• are age 60 or older • have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]• have 3 or more alcoholic drinks every day while using this product• take more or for a longer time than directed

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


• save carton for full directions and warnings• store at 15 30°C (59 86°F) • avoid excessive heat above 40°C (104°F) • do not use if the blue band around the capsule is missing or broken


Call 1-888-842-3567 8:30 AM 4:00 PM ET, Monday Friday

. . . . . . . . . . . . . . . . pain reliever/fever reducer

Drug FactsActive ingredient Purpose

Uses

Warnings

Directions

Other information



(in each capsule)


PEEL





TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL WITHREPEATED TEXT “SEALED FOR YOUR PROTECTION”UNDER CAP IS MISSING OR BROKEN.

NDC 00000-0000-0


g 30 Liquid-Filled Capsules

*Consult your healthcareprovider before using

this product for your heart.


325 mg

FPO

LOT/EXP

If pregnant or breast-feeding, ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose,get medical help or contact a Poison Control Center right away


• save carton for full directions and warnings• store at 15 30°C (59 86°F)• avoid excessive heat above 40°C (104°F)• do not use if the blue band around the capsule is missing or broken


Call 1-888-842-3567 8:30 AM 4:00 PM ET, Monday Friday

Distributed by: PLx Pharma Inc. 8285 El Rio, Suite 130Houston, TX 77054Visit us at: www.companyxxx.com

RETAIN CARTON FOR COMPLETE WARNINGS AND INFORMATION


*nonsteroidal anti inflammatory drug


Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction which may include:• hives • facial swelling • shock • asthma (wheezing)This product contains soy.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:• are age 60 or older

. . . . . . . . . . . . .pain reliever/fever reducer

• have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]• have 3 or more alcoholic drinks every day while using this product• take more or for a longer time than directed

Do not use if you have ever had an allergic reaction to aspirin or any other pain reliever/fever reducer.

Ask doctor before use if• stomach bleeding warning applies to you• you have a history of stomach problems, such as heartburn• you have high blood pressure, heart disease, liver cirrhosis, or kidney disease• you are taking a diuretic• you have asthma


Stop use and ask a doctor if• an allergic reaction occurs. Seek medical help right away.• you are experiencing any of the following signs of stomach bleeding: • feel faint • vomit blood • have bloody or black stools • have stomach pain that doesn’t get better• pain gets worse or lasts more than 10 days• fever gets worse or lasts for more than 3 days• ringing in the ears or loss of hearing occurs• redness or swelling is present in the painful area• any new symptoms occur. These could be signs of a serious condition.


Drug Facts (continued)Drug Facts (continued)

Uses

Warnings

Directions

Other information



No PrintGlue Area

No PrintGlue Area

No PrintGlue Area




g N

DC - 1234-5678-90


LOT/EXP

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL WITH REPEATED TEXT “SEALED FOR YOUR PROTECTION” UNDER CAP IS MISSING OR BROKEN.

Aspirin (NSAID)* 325 mg . . . . . . . . . . . . . . . . pain reliever/fever reducer*nonsteroidal anti inflammatory drug


Reye’s syndrome: Children and teenagers who have or are recovering from chicken pox or flu like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.Allergy alert: Aspirin may cause a severe allergic reaction which may include:• hives • facial swelling • shock • asthma (wheezing)This product contains soy.Stomach bleeding warning: This product contains an NSAID, which may cause severe stomach bleeding. The chance is higher if you:• are age 60 or older • have had stomach ulcers or bleeding problems• take a blood thinning (anticoagulant) or steroid drug• take other drugs containing prescription or nonprescription NSAIDs [aspirin, ibuprofen, naproxen, or others]• have 3 or more alcoholic drinks every day while using this product• take more or for a longer time than directed

If pregnant or breast feeding, ask a health care professional before use. It is especially important not to use aspirin during the last 3 months of pregnancy unless definitely directed to do so by a doctor because it may cause problems in the unborn child or complications during delivery.Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.


• save carton for full directions and warnings• store at 15 30°C (59 86°F)• avoid excessive heat above 40°C (104°F)• do not use if the blue band around the capsule is missing or broken


Call 1 888 842 3567 8:30 AM 4:00 PM ET, Monday FridayDistributed By: PLx Pharma Inc. 8285 El Rio, Suite 130 Houston, TX 77054


Uses

Warnings

Directions

Other information




FPO

LOT/EX

P

NDC 00000-0000-0



*Consult your healthcareprovider before using

this product for your heart.



g TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL W

ITH REPEATED TEXT“SEALED FOR YOUR PROTECTION” UNDER CAP IS MISSING OR BROKEN.


325 mg


Distr

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8285

El R

io, Su

ite 13

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usto

n, TX

7705

4Vi

sit us

at: w

ww.co

mpa

nyxx

x.com

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ith:

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er

Reye

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ndro

me:

Child

ren

and

teen

ager

s who

hav

e or

are

re

cove

ring

from

chick

en p

ox o

r flu

-like

sym

ptom

s sho

uld

not

use

this

prod

uct.

Whe

n us

ing

this

prod

uct,

if ch

ange

s in

beha

vior

with

nau

sea

and

vom

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ur, c

onsu

lt a

doct

or

beca

use

thes

e sy

mpt

oms c

ould

be

an e

arly

sign

of R

eye's

sy

ndro

me,

a ra

re b

ut se

rious

illn

ess.

Alle

rgy

aler

t: As

pirin

may

caus

e a

seve

re a

llerg

ic re

actio

n w

hich

may

inclu

de:

• hiv

es

• fa

cial s

wel

ling

• s

hock

•

asth

ma

(whe

ezin

g)Th

is pr

oduc

t con

tain

s soy

.St

omac

h bl

eedi

ng w

arni

ng: T

his p

rodu

ct co

ntai

ns a

n NS

AID,

w

hich

may

caus

e se

vere

stom

ach

blee

ding

. The

chan

ce is

hi

gher

if y

ou:

• are

age

60

or o

lder

....

....

...p

ain

relie

ver/

feve

r red

ucer

Drug

Fact

sAc

tive i

ngre

dien

t Pu

rpos

e(in

eac

h ca

psul

e)

Uses

War

ning

s

If pr

egna

nt o

r bre

ast-

feed

ing,

ask

a h

ealth

care

pro

fess

iona

l be

fore

use

. It i

s esp

ecia

lly im

port

ant n

ot to

use

asp

irin

durin

g th

e la

st 3

mon

ths o

f pre

gnan

cy u

nles

s def

inite

ly d

irect

ed to

do

so b

y a

doct

or b

ecau

se it

may

caus

e pr

oble

ms i

n th

e un

born

child

or

com

plica

tions

dur

ing

deliv

ery.

Keep

out

of r

each

of c

hild

ren.

In ca

se o

f ove

rdos

e,ge

t med

ical h

elp

or co

ntac

t a P

oiso

n Co

ntro

l Cen

ter r

ight

aw

ay

• drin

k a fu

ll gl

ass o

f wat

er w

ith e

ach

dose

• adu

lts a

nd ch

ildre

n 12

yea

rs a

nd o

ver:

• t

ake

1 or 2

caps

ules

eve

ry 4

hou

rs o

r 3 ca

psul

es

ev

ery

6 ho

urs w

hile

sym

ptom

s per

sist

• d

o no

t exc

eed

12 ca

psul

es in

24 h

ours

• chi

ldre

n un

der 1

2 yea

rs: c

onsu

lt a

doct

or

• s

ave

carto

n fo

r ful

l dire

ctio

ns a

nd w

arni

ngs

• sto

re a

t 15-

30°C

(59-

86°F

)• a

void

exc

essiv

e he

at a

bove

40°

C (10

4°F)

• do n

ot us

e if t

he b

lue b

and a

roun

d the

caps

ule i

s miss

ing o

r bro

ken

an

hydr

ous c

itric

acid

, car

rage

enan

, col

loid

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licon

dio

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C Bl

ue #

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Call

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67 8

:30

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4:0

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Mond

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e ha

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icoag

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ster

oid

drug

• tak

e ot

her d

rugs

cont

aini

ng p

resc

riptio

n or

non

pres

crip

tion

NS

AIDs

[asp

irin,

ibup

rofe

n, n

apro

xen,

or o

ther

s]• h

ave 3

or m

ore a

lcoho

lic d

rinks

ever

y day

whi

le us

ing

this

prod

uct

• tak

e m

ore

or fo

r a lo

nger

tim

e th

an d

irect

ed

Do n

ot u

se if

you

hav

e ev

er h

ad a

n al

lerg

ic re

actio

n to

asp

irin

or

any

othe

r pai

n re

lieve

r/fev

er re

duce

r.

Ask

doct

or b

efor

e us

e if

• sto

mac

h bl

eedi

ng w

arni

ng a

pplie

s to

you

• you

hav

e a

hist

ory

of st

omac

h pr

oble

ms,

such

as h

eart

burn

• you

hav

e hi

gh b

lood

pre

ssur

e, h

eart

dise

ase,

live

r cirr

hosis

,

or k

idne

y di

seas

e• y

ou a

re ta

king

a d

iure

tic• y

ou h

ave

asth

ma

Ask

doct

or o

r pha

rmac

ist b

efor

e us

e if

you

are

• tak

ing

a pr

escr

iptio

n dr

ug fo

r dia

bete

s, go

ut o

r art

hriti

s

Stop

use

and

ask

a d

octo

r if

• an

alle

rgic

reac

tion

occu

rs. S

eek

med

ical h

elp

right

aw

ay.

• you

are e

xper

iencin

g any

of th

e foll

owin

g sig

ns of

stom

ach b

leedi

ng:

• f

eel f

aint

•

vom

it bl

ood

•

have

blo

ody

or b

lack

stoo

ls

• hav

e st

omac

h pa

in th

at d

oesn

’t ge

t bet

ter

• pai

n ge

ts w

orse

or l

asts

mor

e th

an 10

day

s• f

ever

get

s wor

se o

r las

ts fo

r mor

e th

an 3

days

• rin

ging

in th

e ea

rs o

r los

s of h

earin

g oc

curs

• red

ness

or s

wel

ling

is pr

esen

t in

the

pain

ful a

rea

• any

new

sym

ptom

s occ

ur.

Thes

e co

uld

be si

gns o

f a

serio

us co

nditi

on.

Drug

Fact

s (co

ntin

ued)

Drug

Fact

s (co

ntin

ued)

Dire

ctio

ns

Othe

r inf

orm

atio

n

Inac

tive

ingr

edie

nts

Ques

tions

or c

omm

ents


--------------------------------------------------------------------------------------------This is a representation of an electronic record that was signedelectronically. Following this are manifestations of any and allelectronic signatures for this electronic record.--------------------------------------------------------------------------------------------/s/------------------------------------------------------------

THERESA M MICHELE07/25/2018

Signature Page 1 of 1

Reference ID: 4296468(

(nsaid) - accessdata.fda.gov · recovering from chicken pox or flu like symptoms should not use...

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