OMEPRAZOLE AND SODIUM BICARBONATE

Manufacturer
Aurohealth LLC | Aurobindo Pharma Limited
Effective date
2025-12-04
Label type
Human OTC Drug Label
Version
2
Source
full-release
Hydrated at
2026-06-01 01:19:56

Label at a glance#

ProductOMEPRAZOLE AND SODIUM BICARBONATE
Active ingredientOMEPRAZOLE, SODIUM BICARBONATE
Label structure19 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

Label contents#

Full prescribing information#

Active ingredients (in each capsule)

OTC - ACTIVE INGREDIENT SECTION

Omeprazole 20 mg
Sodium Bicarbonate 1100 mg

Purpose

OTC - PURPOSE SECTION

Acid reducer
Allows absorption of this omeprazole product

Use

INDICATIONS & USAGE SECTION

  • 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

Warnings

WARNINGS SECTION

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.

Do not use if you have:

OTC - DO NOT USE SECTION

  • 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.

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.
  • 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 a prescription drug.

OTC - ASK DOCTOR/PHARMACIST SECTION

Acid reducers 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
  • you develop a rash or joint pain

If pregnant or breast-feeding,

WARNINGS 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 contact a Poison Control Center right away (1-800-222-1222).

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

SPL UNCLASSIFIED SECTION

  • 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)

SPL UNCLASSIFIED SECTION

  • 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

SPL UNCLASSIFIED SECTION

  • 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 INGREDIENT SECTION

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?

SPL UNCLASSIFIED SECTION

Call 1-855-274-4122

SPL UNCLASSIFIED SECTION

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

PACKAGE LABEL-PRINCIPAL DISPLAY PANEL - 20 mg/1100 mg (14 Capsules Container Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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 Label)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 Carton Label)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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


 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)

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN2
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD2
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY2

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
BICARBONATE ION Pharmacologic Class Indexing1Indexing - Pharmacologic Class20220121
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
58602-725-05OMEPRAZOLE AND SODIUM BICARBONATE14 in 1 BOTTLECAPSULE142
58602-725-05OMEPRAZOLE AND SODIUM BICARBONATE1 in 1 CARTONCAPSULE12
58602-725-57OMEPRAZOLE AND SODIUM BICARBONATE2 in 1 CARTONCAPSULE22
58602-725-57OMEPRAZOLE AND SODIUM BICARBONATE14 in 1 BOTTLECAPSULE142
58602-725-60OMEPRAZOLE AND SODIUM BICARBONATE14 in 1 BOTTLECAPSULE142
58602-725-60OMEPRAZOLE AND SODIUM BICARBONATE3 in 1 CARTONCAPSULE32

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
58602-72558602-725-05, 58602-725-60, 58602-725-57

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 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 44.

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 · 44 observed states.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-10-15 13:18:302026-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07c2088c7a36db…
2026-09-14 22:38:342026-08A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0784e616aacf4f…
2026-08-18 06:07:402026-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0731067a03dcf5…
2025-08-23 18:47 UTC2025-08A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-076a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0703ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-072680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07d06236e962d9…
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…
2024-05-31 18:47 UTC2024-05A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-078072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-074b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0774a2ff9319b5…
2022-03-09 01:35 UTC2022-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-0787673890dc5c…
2021-03-12 10:30 UTC2021-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-075aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-078869cabd3fbd…
2020-11-12 02:37 UTC2020-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07c0c555d07b60…
2019-12-14 00:12 UTC2019-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073f01610625f2…
2019-09-15 20:21 UTC2019-09A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07b00525d2431f…
2019-07-19 19:46 UTC2019-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-076a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-071c564ffb4f44…
2023-12-20 04:57 UTC2023-12A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-079b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073f0d92c62455…
2023-05-13 08:27 UTC2023-05A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-07053a50430f4f…
2023-01-26 05:58 UTC2023-01A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A204923-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-11-073a93d1ddd44b…

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE AND SODIUM BICARBONATEAurohealth LLC88ad2e92-2228-49b2-bcee-1770fd30cb142025-12-04WarningsExact identifier
ndc (package): 58602-725-57
ndc (package): 58602-725-05
ndc (package): 58602-725-60
ndc (product): 58602-725
ndc11 (package): 58602072557
ndc11 (package): 58602072505
ndc11 (package): 58602072560
spl id: 48c99760-39f6-4e1f-ae95-16a52fc10898
spl set id: 88ad2e92-2228-49b2-bcee-1770fd30cb14

Reported adverse events (FAERS/openFDA)#

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