LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use...

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Transcript of LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use...

Page 1: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

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Page 2: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

Drug Facts

Active ingredient (in each tablet) P

urposeO

meprazole m

agnesium delayed-release tablet 20.6 m

g(equivalent to 20 m

g omeprazole)....................................A

cid reducer

Use

. treats frequent heartburn (occurs 2 or more days a w

eek). not intended for im

mediate relief of heartburn; this drug m

ay take 1 to 4days for full effect

Warnings

Allergy alert: D

o not use if you are allergic to omeprazole

Do not use if you have trouble or pain sw

allowing food, vom

iting with

blood, or bloody or black stools.T

hese may be signs of a serious condition. See your doctor.

Ask a doctor before use if you have

. had heartburn over 3 months. This may be a sign of a more serious

condition.. heartburn w

ith lightheadedness. sweating or dizziness

. chest pain or shoulder pain with shortness of breath; sweating;

pain spreading to arms, neck or shoulders; or Iightheadedness

. frequent chest pain

. frequent wheezing, particularly w

ith heartburn. unexplained weight loss

. nausea or vomiting . stomach pain

Ask a doctor or pharm

acist before use if you are taking. warfarin (blood-thinning medicine)

. prescription antifungal or anti-yeast medicines

. diazepam (anxiety m

edicine). digoxin (heart medicine)

. tacrolimus (immune system medicine)

. atazanavir (medicine for HIV infection)

Stop use and ask a doctor if. your heartburn continues or worsens

. you need to take this product for more than 14 days

. you need to take more than 1 course of treatm

ent every 4 months ~

Drug F

acts (continued)If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children. In case of overdose, get medical help or

contact a Poison C

ontrol Center right aw

ay.

Directions

. adults 18 years of age and older

. this product is to be used once a day (every 24 hours), every day for

14 days. it m

ay take 1 to 4 days for full effect, although some people get

complete relief of sym

ptoms w

ithin 24 hours

14-Day C

ourse of Treatm

ent. sw

allow 1 tablet w

ith a glass of water before eating in the m

orning. take every day for i 4 days

. do not take more than 1 tablet a day

. do not chew or crush the tablets

. do not crush tablets in food

. do not use for more than 14 days unless directed by your doctor

Repeated 14-D

ay Courses (if needed)

. you may repeat a i 4-day course every 4 m

onths. do not take for more than 14 days or more often than every 4

months unless directed by a doctor

. children under 18 years of age: ask a doctor

Other information

. read the directions, warnings and package insert before use

. keep the carton and package insert. They contain important information.

. store at 20-25.C (68-77"F)

. keep product out of high heat and humidity

. protect product from moisture

Inactive ingredients glyceryl monostearate, hydroxypropyl cellulose,

hypromellose, iron oxide, m

agnesium stearate, m

ethacrylic acid copolymer,

microcrystallne cellulose, paraffn, polyethylene glycol 6000, polysorbate

80, polyvinylpyrrolidone, sodium stearyl fum

arate, starch, sucrose, talc,titanium

dioxide, triethyl citrate

Questions? 1.800.759.4841

Product of S

weden D

ist. by Procter &

Gam

ble, Cincinnati, O

H 45202

Page 3: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

Drug FactsActive Inør~dlenr (In each tablet) Purpose

~6~p~~i(~~u'l:~~:~l~~~8%a;~~~~t~~~~~I~)~~~.:... Acid reducer

Drug Facts (continued)

J(IiIlP ou1 of ruth ofchlldNill. Iri case of overdose. getmedical helpo' (ontacta Poisori COlllrol Center tlght;iwav.

Use-treais frequent hurtburn (occurs Zorllor.days a week)-notlntendedfoflmmedlaterellefofheartburn:ihisdfug

may iake 1 to4daysrorfulleffect

Directions.aduln lSyeanofageandoldel. this producl ls 10 be used once a day (eiiery 24 hours),

every day for 14 days

. ~eT~~~~~:\1 ~~I~t~r~~~~t~~:f~~:hr~I~~U~~u~~me people14.Dly Course of TrellmeM. swallow i labll'l wllhil9!i1SS of water before eailng

InlMemomlngI iake every day for 14 daysi do nol lake more tlian i iableladayII ilonolclieworcru~li tlietabteuII do not crii~h tablea In foodii donoiuie for more than 14 days unless dIrected by

youfdoClorReputed 14'Oay Counes (I needed)II yoll may repeat a 14'daycoune every 4 montlisII do not iake for more ihan 14 days or mON! often

ihin every 4 months unless dlrKled by ii doctorII children under 18 year~ of age: a~k a doctor

Wøl'n/ngsAllel'y alert: 00 not u~e ¡fyou arealler!llc ioomeprazoleDo notusii If you have 1I0ubie or paIn swallowln!l food.vomiling wlth blood, or b!oody or black stoolsTline maybe slgnsofase(louscondlllon.5Hyou(dottor.Aska dctor before use iryou hiveIIha~ heartburn over 3 months. This niaybeaslgnofamore

seriouscond,tlon.II heartburn with Ilgluhudedness, sweating or dizzIness. chesipain or shouldeipain with shortness ofbieaih;

sweatln!l; pain spreading to arms, neckor shoulders; orlightheadedness

. frequent dlesl piln

. frequent wheeiing. particularlywiili heal1burnlIunuplainedweighitols . nausea or vomiiing .itomachpainAsk. dO(tor or pharmacist before use If you ire laking. warfarin (blood.thinnlng medicine).preicriptlonantlfungaloranU'yeaiimediclnnII diazepam (an~ietymedkine)II digo~ln (heait medicine)II tacrolimus (immiine system medicine)II atazanavir (medicine for HIV Infection)Stop use ind iik a dOClor If.yourheartbuinconiinuesorwoisensII you need to take this produCl foi more than 14 daysII you need to take moie than 1 cou'seoflltatmenieVtfy4monihl

Other In(ormøtlonII fead the direclions, wainingsand package insert before useII keepthe.carlonand pach!le insert. They contain Important

information.II store al 20.2S'C (68.77'Flii keep product out of high heat and humldiiyii protect produci from moisture

Page 4: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

Drug Facts

Active ingredient (in each tablet) P

urpose

~Q

6p~~

z~~

urrv~ï~

;l~~

~8~

g~~

~e~

~:~

~I~

)~~

~~

.... .Acid reducer

Use

. treats frequent heartburn (occurs 2 or more days a w

eek). not intended for im

mediate relief of heartburn; this drug

may take 1 to 4 days for full effect

Warnings

Allergy

alert: Do not use if you are allergic to om

eprazole

Do not use if you have trouble or pain sw

allowing food,

vomiting w

ith blood. or bloody or black stools.T

hese may be signs of a serious condition. S

ee your doctor.

Ask a docor before use if you have

. had heartburn over 3 months. T

his may be a sign of a m

oreserious condition.

. heartburn with lightheadedness, sw

eating or dizziness. chest pain or shoulder pain w

ith shortness of breath;sw

eating; pain spreading to arms, neck or shoulders; or

lightheadedness. frequent chest pain. frequent w

heezing, particularly with heartburn

. unexplained weight loss . nausea or vom

iting . stomach pain

Ask a docor or pharm

acist before use if you are taking. w

arfarin (blood.thinning medicine)

. prescription antifungal or anti-yeast medicines

. diazepam (anxiety m

edicine). digoxin (heart m

edicine). tacrolim

us (imm

une system m

edicine). atazanavir (m

edicine for HIV

infection)

Stop use and ask a doctor if. your heartburn continues or w

orsens. you need to take this product for m

ore than 14 days. you need to take m

ore than 1 course of treatment every 4 m

onths

~fef~:l~s~~t or breast-feeding, ask a health profeSSional ~

Drug F

acts (continued)K

eep out of reach of children. In case of overdose, getm

edical help or contact a Poison C

ontrol Center right aw

ay.

Directions

. adults 18 years of age and older. this product is to be used once a day (every 24 hours),

every day for 14 days

. ~e~~¿;~ap~~t~ ~~i~t~r~:~:~~~:f~~~hf~t~~u~~u~~me people

14-Day C

ourse of Treatm

ent. sw

allow 1 tablet w

ith a glass of water before eating

in the morning

. take every day for 14 days. do not take m

ore than 1 tablet a day. do not chew

or crush the tablets. do not crush tablets in food. do not use for m

ore than 14 days unless directed byyour doctor

Repeated i 4-D

ay (ou rses (if needed). you m

ay repeat a 14-day course every 4 months

. do not take for more than 14 days or m

ore oftenthan every 4 m

onths unless directed by a doctor. children under 18 years of age: ask a doctor

Other inform

ation. read the directions, w

arnings and package insert before use. keep the carton and package insert. T

hey contain important

information.

. store at 20-25-C (68-7T

F)

. keep product out of high heat and humidity

. protect product from m

oisture

Inactive ingredients glyceryl monostearate,

hydroxypropyl cellulose, hypromellose, iron oxide, m

agnesiumstearate, m

ethacrylic acid copolymer, m

icrocrystallinecellulose, paraffin, poiyethylene glycoi 6000, polysorbate 80,polyvinylpyrrolidone, sodium

stearyl fumarate, starch, sucrose,

talc, titanium dioxide, triethyl citrate

Questions? 1-800-759-4841

Page 5: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

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l U.lnqi.H!"ll iu~nb,,)Jl JO lUillU'l\:i).Jl a4'i .10j POi1C:JIPUI.i

Page 6: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black
Page 7: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black
Page 8: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

¡¡iiiE""-0,,ii 0 ii=..=!~¡""C' '"~8.~::(1 ;;

~~ii"0=ii Uii~~~¡¡ ,- ii;0:::B:~

Page 9: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

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~=8iico;;(\=~ii0;;0.=u.""

Page 10: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

Drug F

llctsD

rug Føcts (continued)A

ctive iltgredieltt (ilt eøch tøblet)Purpose

Stop use and ask a docor ifO

meprazole m

agnesium delayed.release tablet 20,6 m

g. your heartburn continues or w

orsens

(equivlent to 20 mg om

epraole)..............................Acid reducer

. you need to take this product for more than 14 days

. you need to take more than I course of treatm

ent every 4 months

Use

If prenant or breast-feeing, ask a health professional. treats frequent heartburn (occurs 2 or Ifrt days a w

eek)before use,

. not intended for im

mediate relief of hearburn; this drug m

ay take 1 to 4K

eep out of reach of children. In case of overdose, getdays for full effct

medical help or contact a P

oison Control C

enter right away.

Wørltiltgs

Directiolts

Allergy alen: D

o not use if you are allergic to omeprazole

. adults i 8 years of age and older

Do not use if you have trouble or pain sw

allowing foo, vom

iting. this product is to be used once a day (every 24 hours), every day for

with bloo, or bloody or black stools,

14 days

These m

ay be signs of a serious condi~on, See your doctor,. it m

ay take i to 4 days for full effct, although some people get

Ask a docor before use if you have

complete relief of sym

ptoms w

ithin 24 hours

. had hearturn over 3 months. T

his may be a sign of a m

ore serious14-D

ay Course of T

reatment

condition,. sw

allow 1 tablet w

ith a glas of water before eating in the m

orning

. hearurn with Iightheadedness. sw

eating or diuiness. take every day for i 4 days

. chest pain or shoulder pain with shortness of breath; sw

eating;. do not take m

ore than I tablet a day

pain spreading to ars, neck or shoulders; or lightheadedness. do not chew

or crush the tablets

. frequent chest pain. do not crush tablet in food

. frequent wheezing, particularly w

ith hearurn. do not use for m

ore than 14 days unless directed by your doctor

. unexplained weight loss

. nausea or vomiting

. stomach pain

Repeted

14-Day C

ourses (if neeed)

Ask a docor or pharm

acist before use if you are taking. you m

ay repeat a 14-day course every 4 months

. do not late for m

or than 14 days or more often than

. warfrin (bloo.thinning m

edicine)every 4 m

onths unless dire by a docor. prescription antifungal or anti.yeast m

edicines. diazepam

(anxiety medicine)

. children under 18 years of age; ask a docor

. digoxin (heart medicine)

Other iltform

øtiolt. tacrolim

us (imm

une system m

edicine). ataanavir (m

edicine for HIV

infection)~

. read the directions, warnings and package insert before use

~

Page 11: LL C-'€¦ · of heartburn. Allergy alert: Do not use jf you are allergic to omepraole Do not use ¡fyou have trouble or pain swallowing food, vomiting with blood, or bloody or black

Warnings and W

hen to Ask

Your D

octor

when you have heartburn 2 or m

oredays a w

eek.. Prilosec O

TC

is not intended forthose w

ho have heartburninfrequently, one episodeof heartburn a w

eek or less. or forthose w

ho want im

mediate relief

of heartburn.

Allergy alert: D

o not use jf you areallergic to om

epraoleD

o not use ¡fyou have trouble orpain sw

allowing food, vom

iting with

blood, or bloody or black stools.T

hese may be signs of a serious

condition. See your doctor.

Ask il docor before use If you

have. had heartburn over 3 m

onths.T

his may be a sign of a

more serious condition.

. heartburn with lightheadedness,

sweating or dizziness

. chest pain or shoulder pain with

shortness of breath; sweating;

pain spreading to arms, neck or

shoulders; or lightheadedness. frequent chest pain. frequent w

heezing, particularlyw

ith heartburn. unexplained w

eight loss. nausea or vom

iting. stom

ach pain

Ask a doctor or pharm

acistbefore use If you are taking. w

arfrin (bloo-thinning medicine)

. prescription antifungal or anti-yeast m

edicines. diazepam

(anxiety medicine)

. digoxin (heart medicine)

. tacrolimus (im

mune system

medicine)

. atazanavir (medicine for H

IVinfection)

Stop use and uk a docor if. your heartburn continues or

worsens

. you need to take this product form

ore than 14 days. you need to take m

ore than 1course of treatm

ent every 4m

onths

Omaiol tngnesium deJayeJse 0"'''

table120.6mg(equivaletto . ..QO

20 mg om

eprazoe)A

cîd reduce

Plse red all of ihis package insert

bere laking Prlasec O

rr".S

ave this to read, as you nee.

How

Prilosec O

TC

Works F

orY

our Frequent H

eartburn

Prilosec OT

C w

orks differently fromother O

Te heartburn product, such

as antacids and other acid reducers.P

rilosec OT

e stops acid productionat the source - the acid pum

p thatproduces stom

ach acid. Prilosec

OT

C is to be used once a day (every

24 hours), every day for 14 days.

What

to Expect W

hen Using

Prilosec O

TC

Prilosec OT

C is a different type of

medicine from

antacids and otheracid reducers. P

rilosec OT

e may

take 1 to 4 days for full effect,although som

e people get complete

relief of symptom

s within 24 hours.

Make sure you take the entire 14

days of dosing to treat yourfrequent heartburn.

Safety Record

For years, doctors have prescribed

Prilosec to treat acid-related

conditions in milions of people

safely.

Who S

hould Take P

rilosec OT

C

This product is for adults (18 years

and older) with frequent hunburn-

How

to Take P

rilosec OT

C

14-DAY Course of T

reatment

. Sw

allow 1 tablet w

ith a glass ofw

ater before eating in the morning.

. Take every day for 14 days.

. 00 not take more tha 1 talet a day.

. Do not chew

or crush the tablets.. D

o not crush tablets in foo.. D

o not use for more than 14 days

unless directed by your docor.It is im

poant not to chew or crsh

these talets, or crush the talets infoo. T

his decreaes how w

ell Prlosec

OTC work.

When to T

ake Prilosec O

TC

Again

You m

ay repet a 14-y corse oftherapy every 4 m

oths.

When to T

alk to Your D

octorD

o not take for more th 14 days or

more often than every 4 m

onthsunless directed by a docor.

If pregnant or bret-feeding.ask a health professional before use.

Keep oiit of reach of children.

In case of overdose. get medical help

or contact a Poison C

ontrol Center

right away.

Tips for M

anaging Heartburn

. Do not lie flat or bend over soon

after eating.. D

o not eat late at night or justbefore bedtim

e.. C

ertain foods or drinks are more

likely to cause heartburn, such asrich, spicy, fatty and fried foods,chocolate, caffeine, alcohol andeven som

e fruits and vegetables.. E

at slowly and do not eat big

meals.

. If you are overweight, lose w

eight.. If you sm

oke, quit smoking.

. Raise the head of your bed.

. Wear loose-fitting clothing around

your stomach.

How

is Prilosec O

TC

Sold

Prilosec O

TC

is available in 14 tablet,28 tablet and 42 tablet sizes. T

hesesizes contain one, tw

o, and three 14-day courses of treatm

ent,respectively. D

o not use for more

than 14 days in a row unless directed

by your doctor. For the 28 count (tw

o14-day courses) and the 42 count(three 14-day courses), you m

ayrepeat a i 4-day course every 4m

onths.

For Questions or C

omm

entsA

bout Prilosec O

TC

Call1-8(l289-9181

0~