SPL v2
SPL
SPL Set ID 88ad2e92-2228-49b2-bcee-1770fd30cb14
Route
ORAL
Published
Effective Date 2025-12-04
Document Type 34390-5 Human OTC Drug Label

Drug Facts

Composition & Product

Active Ingredients
Omeprazole (20 mg) Bicarbonate Ion (1100 mg)
Inactive Ingredients
Anhydrous Citric Acid Croscarmellose Sodium Fd&c Blue No. 1 Aluminum Lake Gelatin, Unspecified Magnesium Stearate Polysorbate 80 Potassium Sorbate Propylene Glycol Shellac Sodium Lauryl Sulfate Titanium Dioxide

Identifiers & Packaging

Pill Appearance
Imprint: ZEG Shape: capsule Color: white Size: 24 mm Score: 1
Marketing Status
ANDA Active Since 2023-12-22

Description

Omeprazole 20 mg Sodium Bicarbonate 1100 mg

Purpose

Acid reducer Allows absorption of this omeprazole product


Medication Information

Purpose

Acid reducer

Allows absorption of this omeprazole product

Description

Omeprazole 20 mg Sodium Bicarbonate 1100 mg

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 42229-5

How Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

Works For Your Frequent Heartburn



Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and Sodium Bicarbonate Capsules stops acid production at the source - the acid pump that produces stomach acid. Omeprazole and Sodium Bicarbonate Capsules is to be used once a day (every 24 hours), every day for 14 days.



TIPS FOR 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 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


Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/22/2009

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
Other Information
  • each capsule contains: sodium 303 mg
  • read the directions, warnings and accompanying label information before use 
  • store at 20° to 25°C (68° to 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

citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

Questions Or Comments?

Call 1-855-274-4122

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.

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
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
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 Control Center right away (1-800-222-1222).

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.
Active Ingredients (in Each Capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

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
Ask A Doctor Or Pharmacist Before Use If You Are

Acid reducers may interact with certain prescription drugs.

Package Label Principal Display Panel 20 Mg/1100 Mg (14 Capsules Container Label)

AUROHEALTH

NDC 58602-725-05



CLINICALLY PROVEN TO

Treats Frequent Heartburn



Omeprazole and Sodium

Bicarbonate
Capsules



•    
Omeprazole 20 mg / Acid Reducer

•    Sodium Bicarbonate 1100 mg /


        Allows Absorption of this Omeprazole Product



14 Capsules

One 14-Day Course of Treatment

May Take 1 to 4 days for full effect



Package Label Principal Display Panel 20 Mg/1100 Mg (14 Capsules container Carton Label)

AUROHEALTH

NDC 58602-725-05



*Compare to Zegerid OTC® Capsules

Active Ingredients

 CLINICALLY PROVEN TO

Treats Frequent Heartburn

 

Omeprazole and Sodium

Bicarbonate 
Capsules

•    
Omeprazole 20 mg / Acid Reducer

•    Sodium Bicarbonate 1100 mg /


        Allows Absorption of this Omeprazole Product

 

24 Hour

 Actual Size

14 Capsules



One 14-Day Course of Treatment

May Take 1 to 4 days for full effect



 


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 42229-5 (42229-5)

How Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg

Works For Your Frequent Heartburn



Omeprazole and Sodium Bicarbonate Capsules, 20 mg/1100 mg works differently from other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and Sodium Bicarbonate Capsules stops acid production at the source - the acid pump that produces stomach acid. Omeprazole and Sodium Bicarbonate Capsules is to be used once a day (every 24 hours), every day for 14 days.



TIPS FOR 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 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


Distributed by:

AUROHEALTH LLC

279 Princeton-Hightstown Road

East Windsor, NJ 08520



Made in India



Code: TS/DRUGS/22/2009

Purpose

Acid reducer

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
Other Information (Other information)
  • each capsule contains: sodium 303 mg
  • read the directions, warnings and accompanying label information before use 
  • store at 20° to 25°C (68° to 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 (Inactive ingredients)

citric acid anhydrous, croscarmellose sodium, FD&C blue #1 aluminum lake, gelatin, magnesium stearate, polysorbate 80, potassium sorbate, propylene glycol, shellac, sodium lauryl sulphate and titanium dioxide.

Questions Or Comments? (Questions or comments?)

Call 1-855-274-4122

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.

14 Day Course of Treatment (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
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
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Keep Out of Reach of Children. (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).

Repeated 14 Day Courses (if Needed) (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.
Active Ingredients (in Each Capsule) (Active ingredients (in each capsule))

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

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
Ask A Doctor Or Pharmacist Before Use If You Are (Ask a doctor or pharmacist before use if you are)

Acid reducers may interact with certain prescription drugs.

Package Label Principal Display Panel 20 Mg/1100 Mg (14 Capsules Container Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label))

AUROHEALTH

NDC 58602-725-05



CLINICALLY PROVEN TO

Treats Frequent Heartburn



Omeprazole and Sodium

Bicarbonate
Capsules



•    
Omeprazole 20 mg / Acid Reducer

•    Sodium Bicarbonate 1100 mg /


        Allows Absorption of this Omeprazole Product



14 Capsules

One 14-Day Course of Treatment

May Take 1 to 4 days for full effect



Package Label Principal Display Panel 20 Mg/1100 Mg (14 Capsules container Carton Label) (PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Carton Label))

AUROHEALTH

NDC 58602-725-05



*Compare to Zegerid OTC® Capsules

Active Ingredients

 CLINICALLY PROVEN TO

Treats Frequent Heartburn

 

Omeprazole and Sodium

Bicarbonate 
Capsules

•    
Omeprazole 20 mg / Acid Reducer

•    Sodium Bicarbonate 1100 mg /


        Allows Absorption of this Omeprazole Product

 

24 Hour

 Actual Size

14 Capsules



One 14-Day Course of Treatment

May Take 1 to 4 days for full effect



 


Advanced Ingredient Data


Raw Label Data

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