Zegerid OTC

Manufacturer
Bayer HealthCare LLC.
Effective date
2024-12-06
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 00:40:53

Label at a glance#

ProductZegerid OTC
Active ingredientOMEPRAZOLE, SODIUM BICARBONATE
Label structure16 sections

Dosage and administration

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 capsul...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each capsule)

Omeprazole 20 mg

Sodium Bicarbonate 1100 mg

OTC - PURPOSE SECTION

Purpose

Acid reducer

Allows absorption of this omeprazole product

INDICATIONS & USAGE SECTION

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.

WARNINGS SECTION

Warnings

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

OTC - DO NOT USE SECTION

Do not use if you have:

● trouble or pain swallowing food

● vomiting with blood

● bloody or black stools

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

OTC - ASK DOCTOR SECTION

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 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

● frequent wheezing, particularly with heartburn

● unexplained weight loss

● nausea or vomiting

● stomach pain

● a sodium-restricted diet

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking

● 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 medicines)

● prescription antiretrovirals (medicines for HIV infection)

● methotrexate (arthritis medicine)

● any other prescription drugs. Sodium bicarbonate may interact

with certain prescription drugs.

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

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 SAFETY INFORMATION

Other information

● each tablet 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 INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

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

42 count carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Treats Frequent Heartburn

Zegerid OTC ®

• Omeprazole 20 mg/Acid Reducer

• Sodium Bicarbonate 1100 mg/
Allows Absorption of this Omeprazole Product

42 CAPSULES

Three 14-Day Courses of Treatment

Zegerid Carton 42 ctZegerid Carton 42 ct

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN6
646344Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006PSN6
646344omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SBD6
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD6
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY6
646344Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SY6
646344Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006SY6
646344Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral CapsuleSY6

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
OMEPRAZOLE Pharmacologic Class Indexing3Indexing - Pharmacologic Class20180813
SODIUM CATION Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
95250459-30e4-45c1-b08a-993044f49109Product name220250805
726062af-1135-4707-a1d7-57256991bbf9Product name220250226
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fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
6bd95106-a412-1dad-b9cc-4cb74bfb27ceProduct name220230315
f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
9badc7be-250a-44ab-aa36-926af3f02679Product name120210527
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
f33561b9-47cb-411c-a228-16c62e346cd4Product name120200415
6e9d4a47-c464-b93e-aebc-ad7bffc9c4cdProduct name220190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
26acd337-b838-40ac-bcbc-05c3b81c8712Product name120170323
ade821ba-260a-47e2-bd89-743e27ac9906Product name120161121
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
290f523a-f9db-9774-b5a9-e1f908ac1782Product name120150828
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89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
19c71a3d-ed9c-166b-a7e5-38c250c35631Product name120140508
5668b646-cd56-c3c7-bdea-3f6b1a8840dbProduct name120140508
597b1cfd-7b31-5048-62be-ca5cd740da2fProduct name120140508
684ea482-2e8b-14af-5664-b98f1e402036Product name120140508
810ab97e-f109-f41c-7c83-6a652a9cbf43Product name120140508
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
8dbefedf-0a0d-a224-5a3c-66dc9e11c2ddProduct name120140508
b060cc1a-fe47-856b-0b77-4448b5963de8Product name120140508
c6b65c52-69c7-df49-550a-a50c137f6218Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508
ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
11523-7276-12026-01-29C16284748780-149896155-a3ee-586f-e063-e6dba90add90Zegerid OTC
11523-7276-22026-01-29C16284748780-149896155-a3ee-586f-e063-e6dba90add90Zegerid OTC

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11523-7276-1Zegerid OTC1 in 1 CARTONCAPSULE, GELATIN COATED16
11523-7276-1Zegerid OTC14 in 1 BOTTLECAPSULE, GELATIN COATED146
11523-7276-2Zegerid OTC1 in 1 CARTONCAPSULE, GELATIN COATED16
11523-7276-2Zegerid OTC42 in 1 BOTTLECAPSULE, GELATIN COATED426

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11523-7276ZEGERID OTC (OMEPRAZOLE AND SODIUM BICARBONATE) CAPSULE, GELATIN COATED [BAYER HEALTHCARE LLC.]6Legacy NDC, 4 package rows20241208_5ad1ca2b-3119-b8c2-e053-2a91aa0a2f77.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11523-727611523-7276-1, 11523-7276-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 9 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
A201361-001OMEPRAZOLE AND SODIUM BICARBONATEOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15

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.

Captured, Edition, Application-product table
CapturedEditionApplication-productTrade nameStrengthDosage form / routeProduct TE source textRLD / RSApproval dateSource SHA-256
2026-09-14 22:38:342026-08A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1584e616aacf4f…
2026-08-18 06:07:402026-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15caaa826d4ba7…
2026-02-19 14:30 UTC2026-02A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1531067a03dcf5…
2025-08-23 18:47 UTC2025-08A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-156a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1503ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-152680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15d8e5a09893c0…
2024-10-29 15:01 UTC2024-10A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1579d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-151e350fbaab3a…
2024-05-31 18:47 UTC2024-05A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-158072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155d02ea3f76ae…
2022-04-04 05:41 UTC2022-04A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-154b0b4de00fa7…
2019-12-13 00:20 UTC2019-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1574a2ff9319b5…
2022-03-09 01:35 UTC2022-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-1587673890dc5c…
2021-03-12 10:30 UTC2021-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-155aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-158869cabd3fbd…
2020-11-12 02:37 UTC2020-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15c0c555d07b60…
2019-12-14 00:12 UTC2019-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153f01610625f2…
2019-09-15 20:21 UTC2019-09A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15b00525d2431f…
2019-07-19 19:46 UTC2019-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-156a51e52b5d6a…
2024-02-18 07:12 UTC2024-02A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-151c564ffb4f44…
2023-12-20 04:57 UTC2023-12A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-159b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153f0d92c62455…
2023-05-13 08:27 UTC2023-05A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15053a50430f4f…
2023-01-26 05:58 UTC2023-01A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-153a93d1ddd44b…
2022-10-28 04:53 UTC2022-10A201361-001OMEPRAZOLE AND SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORAL2016-07-15f41ea6bd6efb…

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
289f551a-8150-f7bf-e063-6394a90a3ed85ad1ca2b-3119-b8c2-e053-2a91aa0a2f772024-12-06WarningsExact identifier
spl id: 289f551a-8150-f7bf-e063-6394a90a3ed8
spl set id: 5ad1ca2b-3119-b8c2-e053-2a91aa0a2f77

Reported adverse events (FAERS/openFDA)#

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