Drug Facts

Composition & Product

Active Ingredients

Omeprazole (20 mg) Sodium Cation (1100 mg)

Inactive Ingredients

Fd&c Blue No. 1 Fd&c Blue No. 2 Aluminum Lake Fd&c Red No. 40 Gelatin, Unspecified Polysorbate 80 Sodium Lauryl Sulfate Sodium Starch Glycolate Type A Sodium Stearyl Fumarate Titanium Dioxide

Identifiers & Packaging

Pill Appearance

Imprint: ZEG Shape: oval Color: white Size: 23 mm Score: 1

Marketing Status

NDA Active Since 2024-03-01

Medication Information

Description

Active Ingredients (in each capsule) Purpose Omeprazole 20 mg Acid reducer Sodium Bicarbonate 1100 mg Allows absorption of this omeprazole product

Use

treats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn.

This drug may take 1 to 4 days for full effect.

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50568-5

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9

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

Section 55106-9

Active Ingredients (in each capsule)	Purpose
Omeprazole 20 mg	Acid reducer
Sodium Bicarbonate 1100 mg	Allows absorption of this omeprazole product

Warnings

Allergy alert:

do not use if you are allergic to omeprazole.
omeprazole may cause severe skin reactions

Symptoms may include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away

Directions

for 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 may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
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
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

Heartburn in children may sometimes be caused by a serious condition.

Other Information

each capsule contains: sodium 303 mg
read the directions, warnings and accompanying label information before use
store at 20°- 25°C (68°-77°F)
tamper-evident: do not use if 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.
keep product out of high heat and humidity
protect product from moisture

Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions Or Comments?

Call 1-888-4-ZEG-OTC (1-888-493-4682) between: 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health

Zegerid OTC is a registered trademark of Santarus, Inc.

Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health

New York, NY 10151

Do Not Use If You Have:

trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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

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

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
you get diarrhea
you develop a rash or joint pain

Ask A Doctor Before Use If You Have

had heartburn over 3 months. This may be a sign of a more serious condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
a sodium-restricted diet.

Package Label.principal Display Panel

HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN

Zegerid OTC works differently from other OTC heartburn products, such as antacids and other

acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces

stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.

TIIPS FOR MANAGING HEARTBURN

Do not lie flat or bend over after eating
Do not eat late at night or just before bedtime
Certain foods or drinks are more likely to cause heartburn,

such as rich, spicy, fatty 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
Raise the head of your bed
Wear loose-fitting clothing around your stomach

CLINICALLY PROVEN TO

Treat Frequent Heartburn

Zegerid

OTC^®

Omperazole 20mg / Acid Reducer
Sodium Bicarbonate 1100mg

/Allows Absorption of this

Omperazole Product

14 CAPSULES

One 14-Day Course of Treatment

MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT

24 HOUR

1H9D5 XL C1

Structured Label Content

Use

treats frequent heartburn (occurs 2 or more days a week)
not intended for immediate relief of heartburn.

This drug may take 1 to 4 days for full effect.

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.

Section 53414-9 (53414-9)

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

Section 55106-9 (55106-9)

Active Ingredients (in each capsule)	Purpose
Omeprazole 20 mg	Acid reducer
Sodium Bicarbonate 1100 mg	Allows absorption of this omeprazole product

Warnings

Allergy alert:

do not use if you are allergic to omeprazole.
omeprazole may cause severe skin reactions

Symptoms may include:
- skin reddening
- blisters
- rash
If an allergic reaction occurs, stop use and seek medical help right away

Directions

for 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 may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours

14-Day Course of Treatment

swallow 1 capsule with a glass of water at least 1 hour before eating in the morning
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
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

Heartburn in children may sometimes be caused by a serious condition.

Other Information (Other information)

each capsule contains: sodium 303 mg
read the directions, warnings and accompanying label information before use
store at 20°- 25°C (68°-77°F)
tamper-evident: do not use if 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.
keep product out of high heat and humidity
protect product from moisture

Inactive Ingredients

FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-888-4-ZEG-OTC (1-888-493-4682) between: 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday

Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health

Zegerid OTC is a registered trademark of Santarus, Inc.

Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health

New York, NY 10151

Do Not Use If You Have: (Do not use if you have:)

trouble or pain swallowing food, vomiting with blood, or bloody or black stools
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

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

Stop Use and Ask A Doctor If (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
you get diarrhea
you develop a rash or joint pain

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)

had heartburn over 3 months. This may be a sign of a more serious condition.
frequent wheezing, particularly with heartburn
unexplained weight loss
nausea or vomiting
stomach pain
a sodium-restricted diet.

Package Label.principal Display Panel (PACKAGE LABEL.PRINCIPAL DISPLAY PANEL)

HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN

Zegerid OTC works differently from other OTC heartburn products, such as antacids and other

acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces

stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days.

TIIPS FOR MANAGING HEARTBURN

Do not lie flat or bend over after eating
Do not eat late at night or just before bedtime
Certain foods or drinks are more likely to cause heartburn,

such as rich, spicy, fatty 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
Raise the head of your bed
Wear loose-fitting clothing around your stomach

CLINICALLY PROVEN TO

Treat Frequent Heartburn

Zegerid

OTC^®

Omperazole 20mg / Acid Reducer
Sodium Bicarbonate 1100mg

/Allows Absorption of this

Omperazole Product

14 CAPSULES

One 14-Day Course of Treatment

MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT

24 HOUR

1H9D5 XL C1

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"Use": "treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect. ", "50565-1": "Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222).", "50568-5": "Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs.", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "55106-9": "Active Ingredients (in each capsule) Purpose Omeprazole 20 mg Acid reducer Sodium Bicarbonate 1100 mg Allows absorption of this omeprazole product", "Warnings": "Allergy alert: do not use if you are allergic to omeprazole. omeprazole may cause severe skin reactions Symptoms may include: skin reddening blisters rash If an allergic reaction occurs, stop use and seek medical help right away", "Directions": "for 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 may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 capsule with a glass of water at least 1 hour before eating in the morning 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 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 Heartburn in children may sometimes be caused by a serious condition.", "Other information": "each capsule contains: sodium 303 mg read the directions, warnings and accompanying label information before use store at 20°- 25°C (68°-77°F) tamper-evident: do not use if 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. keep product out of high heat and humidity protect product from moisture", "Inactive Ingredients": "FD&C blue no. 1, FD&C blue no. 2 aluminum lake, FD&C red no. 40, gelatin, polysorbate 80, sodium lauryl sulfate, sodium starch glycolate, sodium stearyl fumarate, titanium dioxide", "Questions or comments?": "Call 1-888-4-ZEG-OTC (1-888-493-4682) between: 9:00 AM and 5:00 PM Eastern Standard Time, Monday through Friday Zegerid OTC design logo is a registered trademark of Riley Consumer Care, LLC d/b/a Carlin Consumer Health Zegerid OTC is a registered trademark of Santarus, Inc. Dist by: Riley Consumer Care, LLC d/b/a Carlin Consumer Health New York, NY 10151", "Do not use if you have:": "trouble or pain swallowing food, vomiting with blood, or bloody or black stools 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 These may be signs of a serious condition. See your doctor.", "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 you get diarrhea you develop a rash or joint pain", "Ask a doctor before use if you have": "had heartburn over 3 months. This may be a sign of a more serious condition. frequent wheezing, particularly with heartburn unexplained weight loss nausea or vomiting stomach pain a sodium-restricted diet.", "PACKAGE LABEL.PRINCIPAL DISPLAY PANEL": "HOW ZEGERID OTC WORKS FOR YOUR FREQUENT HEARTBURN Zegerid OTC works differently from other OTC heartburn products, such as antacids and other acid reducers. Zegerid OTC stops acid production at the source - the acid pump that produces stomach acid. Zegerid OTC is to be used once a day (every 24 hours), every day for 14 days. TIIPS FOR MANAGING HEARTBURN Do not lie flat or bend over after eating Do not eat late at night or just before bedtime Certain foods or drinks are more likely to cause heartburn, such as rich, spicy, fatty 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 Raise the head of your bed Wear loose-fitting clothing around your stomach CLINICALLY PROVEN TO Treat Frequent Heartburn Zegerid OTC ® Omperazole 20mg / Acid Reducer Sodium Bicarbonate 1100mg /Allows Absorption of this Omperazole Product 14 CAPSULES One 14-Day Course of Treatment MAY TAKE 1 TO 14 DAYS FOR FULL EFFECT 24 HOUR 1H9D5 XL C1"}

Drug Facts

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information