Omeprazole and Sodium Bicarbonate

Manufacturer
Aurolife Pharma, LLC | Aurolife Pharma LLC
Effective date
2019-09-11
Label type
Human OTC Drug Label
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:12:35

Label at a glance#

ProductOmeprazole and Sodium Bicarbonate
Active ingredientOMEPRAZOLE, SODIUM BICARBONATE
Label structure21 sections

Dosage and administration

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 one hour before eating in the morning take every day for 14 days do not take more than 1 capsule a day do not chew o...

Storage and handling

each capsule contains: sodium 303 mg read the direction, 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 is missing, open or broken. keep product out of high heat and humidity prtect product from moisture

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION


Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose

OTC - PURPOSE SECTION


Acid reducer
Allows absorption of this omeprazole product

Use(s)

INDICATIONS & USAGE SECTION

  • treats frequent heartburn (occurs 2 or more days a week)
  • not intended for immediate relief of hearburn. This drug may take 1 to 4 days for full effect.

Warnings

WARNINGS SECTION


Allergy alert: Do not use if you are allergic to omeprazole

Do not use if you have:

OTC - DO NOT USE SECTION

  • touble or pain swallowing food
  • vomiting with blood
  • bloody or black stools

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • had heartburn over 3 months.  This may be a sign of a more serious condition.
  • heartburn with lightheadedness, sweating or diziness
  • chest pain or shoulder pain with shortness of breath; sweating; pain spreading to arms, neck or shoulder; or lightheadedness
  • frequent chest pain
  • 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 taking

OTC - ASK DOCTOR/PHARMACIST SECTION

  • warfarin, clopidogrel or cilostazol (blood-thinning medicines)
  • prescription antifungal or anti-yeast medicines
  • diazepam (anxiety medicine)
  • digoxin (heart medicine)
  • tacrolimus or Mycophenolate mofetil (immune system medicine)
  • prescription antiretrovirals (medicines for HIV infection)
  • Methotrexate (arthiritis medicine)
  • any other prescription drugs, Sodium bicarbonate may interact with certain prescription drugs.

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION


ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION


In case of overdose, get medical help or contract a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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 one 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 ofen than every 4 months unless directed by a doctor
  • children under 18 years of age; ask a doctor. Heartburn in children may sometines be caused by a serious condition.

Other information

STORAGE AND HANDLING SECTION

  • each capsule contains: sodium 303 mg
  • read the direction, 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 is missing, open or broken.
  • keep product out of high heat and humidity
  • prtect product from moisture

Inactive Ingredients

INACTIVE INGREDIENT SECTION


citric acid, croscarmellose sodium, FD&C Blue # 1, FD&C Red # 3, gelatin, magnesium stearate NF, pharmaceutical ink, polysorbate 80, potassium hydroxide NF, potassium sorbate, propylene glycol, Shellac,sodium lauryl sulphate, titanium dioxide,    

Questions or Comments?

SPL UNCLASSIFIED SECTION


Call toll-free 1-866-850-2876

How Omeprazole and Sodium Bicarbonate Capsules Work For Your Frequent Heartburn

SPL UNCLASSIFIED SECTION


Omeprazole and sodium bcarbonate capsules work differently form other OTC heartburn products, such as antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules stop acid production at the source-the acid pump that produces stomach acid. Omeprazole and sodium bicarbonate capsules are to be used once a day (every 24 hours), every day for 14 days.

What to Expect When Using Omeprazole and Sodium Bicarbonate Capsules

SPL UNCLASSIFIED SECTION


Omeprazole and sodium bicarbonate capsules is a different type of medicine from antacids and other acid reducers. Omeprazole and sodium bicarbonate capsules may take 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.

Tips for Managing Heartburn

SPL UNCLASSIFIED SECTION

  • 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 likelhy 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.

How are Omeprazole and Sodium Bicarbonate Capsules Sold

SPL UNCLASSIFIED SECTION


Omeprazole and sodium bicarbonate capsules are availble in 14, 28 and 42 count sizes. These sizes contain one, two and three 14-day courses of treatment, respectively. Do not use of more than 14 days in a row unless directed by your doctor. For the 28 count (two 14-day courses) and the 42 count (three 14-day courses), you may repeat a 14-day course every 4 months.

PRINCIPAL DISPLAY PANEL - 14 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


* Compare to Zegerid OTC® Capsules                           NDC 13107-117-14
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules

  • Omeprazole 20 mg / Acid Reducer
  • Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product

                                14 Capsules
One 14-Day Course of Treatment

Aurobindo

omeprazoleomeprazole


PRINCIPAL DISPLAY PANEL - 28 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


* Compare to Zegerid OTC® Capsules                 NDC 13107-117-28
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules

  • Omeprazole 20 mg / Acid Reducer
  • Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product

                                 28 Capsules
Two 14-Day Course of Treatment

Aurobindo

omeprazoleomeprazole

PRINCIPAL DISPLAY PANEL - 42 Capsule Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL


* Compare to Zegerid OTC® Capsules                          NDC 13107-117-42
Active Ingredients


Treats Frequent Heartburn


Omeprazole and Sodium Bicarbonate Capsules

  • Omeprazole 20 mg / Acid Reducer
  • Sodium Bicarbonate 1100 mg / Allows Absorption of this Omperazole Product

                                   42 Capsules
Three 14-Day Course of Treatment

Aurobindo

omeprazoleomeprazole

FDA-Initiated Inactive NDC Indexing#

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13107-117OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE [AUROLIFE PHARMA, LLC]2Legacy NDC20190912_bfaf1e69-cbe9-4dde-8f65-6e730f47120a.zip

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13107-11713107-117-14, 13107-117-28, 13107-117-42

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

Orange Book application contexts#

All distinct exact application/product contexts derived from this label’s complete NDC list are paginated below.

Orange Book application contexts page 1 of 1 · 1 matching rows.

Source provenance: Browse the complete Orange Book source catalog · source snapshot 43.

Orange Book products#

Current product rows page 1 of 1 · 1 matching rows.

Application-product, Trade name, Ingredient table
Application-productTrade nameIngredientStrengthDosage form / routeTE codesRLD / RSApproval date
A204923-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07

Observed Orange Book product history#

Observed FDA ZIP history: Each table is queried independently by exact application/product key from successfully parsed Orange Book snapshots. Capture times identify archived source observations; absence or a change between snapshots is not inferred. FDA publication files that were not recoverable as structured ZIP data are not represented as states.

Product history page 1 of 2 · 43 observed states.

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2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075bbf6a4d5a75…
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2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0779d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-071e350fbaab3a…
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2022-10-28 04:53 UTC2022-10A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07f41ea6bd6efb…

openFDA label cross-check#

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
ae92e1a9-c0a3-4c3d-b1e6-2f7f7c81e29bbfaf1e69-cbe9-4dde-8f65-6e730f47120a2025-12-08WarningsExact identifier
spl set id: bfaf1e69-cbe9-4dde-8f65-6e730f47120a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.