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rug Facts (continued)

. frequent chest painD

irections. frequent w

heezing, particularly with heartburn

. for adults 18 years of age and older. unexplained w

eight loss .this product is to be used once a day (every

. nausea or vomiting

24 hours), every day for 14 days. stom

ach pain. it m

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

. a sodium-restricted diet

people get complete relief of sym

ptoms w

ithinA

sk a doctor or pharmacist before use if you are

24 hours

taking14.0ay C

ourse olTeatm

ent. w

artarin, clopidogrel or cilostazol. sw

allow t capsule w

ith a glass of water at least

(blood.thinning medicines)

1 hour before eating in the morning

. prescription antifungal or anti-yeast medicines

. take every day for 14 days. diazepam

(anxiety medicine)

. do not take more than 1 capsule a day

. digoxin (heart medicine)

. do not chew or crush the capsule

. tacrolimus (im

mune system

medicine)

. do not open capsule and sprinkle on food. prescription antiretrovirals (m

edicines for. do not use for m

ore than 14 days unless directedH

IVinfection)

by your doctor. any other prescription drugs. Sodium

bicarbonate may

Repeated 14-ay C

ourses (if needed I interact w

ith certain prescription drugs.

Stop use and ask a doctor if.you m

ay repeat a 14-day course every 4 months

. do not take for more than 14 days or m

ore offen. your heartburn continues or w

orsensthan every 4 m

onths unless directed by a doctor. you need to take this product for m

ore than 14 days. children under 18 years of age: ask a doctor.

. you need to take more than 1 course of treatm

entH

eartburn in children may som

etimes be caused by

every 4 months

a serious condition. ~ff pregnant or breast-feeding, ask a healthprofessional before use.K

eep out of reach ot children. In case of overdose,get m

edical help or contact a Poison Control C

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Other inform

ation. each capsule contains: sodium

303 mg

. read the directions, warnings and accom

panyinglabet inform

ation before use. store at 20'-25'C

(68'.7lFI. tam

per-evident: do not use it the blue band aroundthe capsule is m

issing or broken. Do not use if foil

inner seal imprinted w

ith 'Sealed for your protectiois m

issing, open or broken.. keep product out of high heat and hum

idity. protect product from

moisture

tnactive ingredientscroscarm

ellose sodium, FD

&C

blue NO

.1, gelatin,m

agnesium stearate, pharm

aceutical ink, polysorbate80, titanium

dioxide

Questions or com

ments?

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Central T

ime, M

onday througFriday or visit w

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Drug F

acts

Active ingredients Purpose

(in each capsule)O

meprazole 20 m

g................................... Acid reducer

Sodium B

icarbonate 1100 mg......................................

.............Allow

s absorption of this omeprazole product

Use

. treats frequent heartburn (occurs 2 or more days

a week)

. not intended for imm

ediate relief of heartburn. This

drug may take 1 to 4 days for full eliecl.

Warnings

Allergy alert: D

o not use if you are allergic toom

eprazole

Do not use if you have:

. trouble or pain sw

allowing food

. vomiting w

ith blood. bloody or black stoolsT

hese may be signs of a serious condition. See your

doctor.

Ask a doctor before use if you have

. had heartburn over 3 months. T

his may be a sign of

a more serious condition.

. heartburn with Ilghtheadedness, sw

eating ordizziness

. chest pain or shoulder pain with shortness of

breath; sweating: pain spreading to arm

s, neck orshoulders; or lightheadedness ~

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06.06.11- ju

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Reference ID: 2974588Reference ID: 2978199

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Drug Facts (continued)f- Use. treats frequent heartburn (occurs 2 or more days a week). not intended for immediate relief of heartbum. This drug may take 1 to 4 days for full ellect.

Warnings-- Allergy alert: Do not use it you are allergic to omeprazole

Do not use if you have:

~. trouble or pain swallowing food

B - ra(Q~~ lP(QUl~~

Printable Text Area

I~ 3.25-~i

Drug Facts (continued). vomiting with blood. bloody or black stoolsThese may be signs of a serious condition. See your doctor.

~.~25-Ask a doctor before use if you have. had heartburn over 3 months. This may be a sign of a more serious condition.. heartburn with Iightheadedness, sweating or dizziness

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Drug Facts (continued)Ask a doctor or pharmacist before use if you are taking. wartarin, clopidogrel or cilostazol (blood-thinning medicines). prescription antifungal or anti-yeast medicines. diazepam (anxiety medicine). digoxin (heart medicine). tacrolimus (immune system medicine). prescription antiretrovirals (medicines for HIV infection). any other prescription drugs. Sodium bicarbonate may interact with certain prescription drugs. ~

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JUN 2 9 2011

Open 10 read directons and additional drug fact infonnaton

Drug Facts

Active ingredients Purpose(in each capsule)Omeprazole 20 mg ........................... Acid reducerSodium Bicarbonate 1100 mg ...................................Allows absorption of this omeprazole product

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Treats Freqent Hearburn

Zegerlrt, Omepfie2DmglAcitlReducer, SoóíumBicadHnate IIODmglAIowsAbsdfltinQlth Omepl2olePrud 14

One 14.0ayCoulSeQITrealmenl CAlE

NDC 11523-7265-1

if Copyright & Distributed byMSD Consumer Care, Inc.,PO 80x377, Memphis, TN 38151 USA.a subsidiary of Merck & Co" Inc.,Whitehouse Station, NJ USA.All rights reserved. Product of Spain.

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T Drug Facts (continued). chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or

shoulders; or lightheadedness

.9315 . frequent chest pain. frequent wheezing, particularly with heartburn

1 . unexplained weight loss. nausea or vomiting. stomach pain

~. a sodium-restricted diet

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Drug Facts (continued)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 treatment every 4 months

It pregnant or breast-teeding, ask a health professional before use.Keep out of reach of children. In case of overdose, get medical help or contact a Poison ControlCenter right away.

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Drug Facts (continued)

Directions. for adulfs 18 years of age and older. this product is to be used once a day (every 24 hours), every day for 14 days. it may take 1 to 4 days for full effect, although some people get complete relief of symptoms

within 24 hours

14-Doy Course ot Treatment. swallow 1 capsule with a glass of water at least one hour before eating in the morning

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. do not take for more than 14 days or more offen than every 4 months unless directed bya doctor

. children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused bya serious condition,

Other information. each capsule contains: sodium 303 mg. read the directions, warnings and accompanying label information before use

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Inactive ingredientscroscarmellose sodium, FD&C blue No, 1, gelatin, magnesium stearate, pharmaceutical ink,polysorbate 80, titanium dioxide

Questions or comments?Ca!ll-888-4ZEG-DTC (1-88a-493-4682) between 8:00 AM and 5:00 PM Central Time,Monday through Friday or visit \V,ZegeridDTC,com

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Tips IDr Managing Heartburn. Do not lie flat or bend over soon after eating,. Do not eat late at night or just before bedtime,. Certain foods or drinks are more likeiy to cause heartburn, such as rich, spicy, fatt and fried foods,

chocolate, caffeine, alcohol and even some fruits and vegetables,. Eat slowly and do not eat big meals,. If you are overweight, lose weight.. If you smoke, quit smoking,

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ATTACH LEGEND ON All

DIGITAL MECHANICAlS

STANDARD FORMAT

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(continued) - 8 pt Helvetica Cnd,

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Text - 6 pt Helvetica Cnd, minimum leading 6,5

Square Bullets - 3,5 pt Zaph Dingbats no compression


Barline -1 pt rule

Hairline - ,5 pI rule

JUN 2 9 2011

/'Drug Facts (continued)

. take every day for 14 days

. do not take more than 1 capsule a day

. do not chew or crush the capsule

. do not open capsule and sprinkle on food

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

Repeated 14-Day Courses (if needed)

~. you may repeat a 14-day course every 4 months

H - ~l1$~ir J ra(Q~fk

Drug Facts (continued). store at 20'-25'C (68'-7lF). tamper-evident: do not use IT the blue band around the capsule is missing or broken, Do not use

if foil inner seal imprinted with 'Sealed for your protection' is missing, open or broken,a keep product out of high heat and humidity

. protect product from moisture

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How Zegerid OTe Works For Your Frequent HeartburnZegerid OTC works differently from other OTC heartburn products, such as antacids and other acidreducers, Zegerid OTC stops acid production at the source -the acid pump that produces stomachacid, Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days,

What to Expect When Using Zegerid OTeZegerid DTC is a different type of medicine from antacids and other acid reducers, Zegerid OTC maytake 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours,Make sure you take the entire 14 days of dosing to treat your frequent heartburn,

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. Raise the head of your bed,

. Wear loose-fiffing clothing around your stomach,

HDW is Zegerid OTe SoldZegerid DTC is available in 14 and 42 count sizes, These sizes contain one and three 14-day coursesof treatment, respectively, 00 not use for more than 14 days in a row unless directed by your doctor,For the 42 count (three 14-day courses). you may repeat a 14-iay course every 4 months,

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--Reference ID: 2974588Reference ID: 2978199

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----------------------------------------------------

This is a representation of an electronic record that was signed electronically and this page is the manifestation of the electronic signature.

/s/

JOEL SCHIFFENBAUER 07/25/2011

Reference ID: 2978199

Documents

Zèl1~lf - Food and Drug Administration · frequent chest pain Directions. frequent wheezing, particularly with heartburn ... A - 1(Q!p lP(QUl~~ ~ ZegerlrtTreats Freqent Hearburn,