Zegerid OTC

Manufacturer
Riley Consumer Care LLC
Effective date
2025-12-24
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:29:03

Label at a glance#

ProductZegerid OTC
Active ingredientOmeprazole, Sodium Bicarbonate
Label structure14 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 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 ...

Storage and handling

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

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active Ingredients
(in each capsule)
Purpose
Omeprazole 20 mgAcid reducer
Sodium Bicarbonate 1100 mgAllows 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.

OTC - ASK DOCTOR/PHARMACIST SECTION

Ask a doctor or pharmacist before use if you are taking a prescription drug. 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

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 (1-800-222-1222).

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

  • 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

STORAGE AND HANDLING SECTION

  • 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

INACTIVE INGREDIENT SECTION

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

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

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

Carton
Carton
42 count carton
42 count carton
inner labels
inner labels

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsulePSN3
646344Zegerid 20 MG / 1100 MG Oral Capsule, Reformulated Aug 2006PSN3
646344omeprazole 20 MG / sodium bicarbonate 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SBD3
616539omeprazole 20 MG / sodium bicarbonate 1100 MG Oral CapsuleSCD3
616539Omeprazole 20 MG / NaHCO3 1100 MG Oral CapsuleSY3
646344Omeprazole 20 MG / NaHCO3 1100 MG Oral Capsule [Zegerid Reformulated Aug 2006]SY3
646344Zegerid (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral Capsule, Reformulated Aug 2006SY3
646344Zegerid Reformulated Aug 2006 (omeprazole 20 MG / sodium bicarbonate 1100 MG) Oral CapsuleSY3

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
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f1e0dc7e-7d61-4625-b6d9-4894927679d7Product name220211025
873ef493-6b37-49d8-ac7f-bfca4117d2c1Product name520210607
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08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
e4870509-7e28-6f92-f0be-dd3dd889a9cfProduct name520200810
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ed912195-5da0-0f2f-6f4b-3ef17710cbe3Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
82632-100-01Zegerid OTC1 in 1 CARTONCAPSULE13
82632-100-01Zegerid OTC14 in 1 BOTTLECAPSULE143
82632-100-03Zegerid OTC42 in 1 BOTTLECAPSULE423
82632-100-03Zegerid OTC1 in 1 CARTONCAPSULE13

Products#

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

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82632-10082632-100-01, 82632-100-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 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
N022281-001ZEGERID OTCOMEPRAZOLE; SODIUM BICARBONATE20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01

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 13:18:302026-09N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01c2088c7a36db…
2026-09-14 22:38:342026-08N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-0184e616aacf4f…
2026-08-18 06:07:402026-07N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01caaa826d4ba7…
2026-02-19 14:30 UTC2026-02N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01011fe1cb6892…
2025-12-14 10:44 UTC · 2 captures of this ZIP2025-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-0131067a03dcf5…
2025-08-23 18:47 UTC2025-08N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-016a471c1ec25d…
2025-03-22 03:13 UTC · 3 captures of this ZIP2025-03N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01fd3edfee7708…
2025-02-26 10:13 UTC · 3 captures of this ZIP2025-02N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01b8a1b40f171c…
2025-01-19 17:59 UTC · 7 captures of this ZIP2025-01N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-0103ed91905a0d…
2024-12-13 21:23 UTC · 2 captures of this ZIP2024-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-012680178bc6a6…
2024-09-14 05:58 UTC · 2 captures of this ZIP2024-09N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-015bbf6a4d5a75…
2024-11-08 22:44 UTC · 3 captures of this ZIP2024-11N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01d8e5a09893c0…
2024-10-29 15:01 UTC2024-10N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01d06236e962d9…
2024-08-13 05:28 UTC · 3 captures of this ZIP2024-08N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-0179d66fd596c7…
2024-07-13 05:37 UTC · 2 captures of this ZIP2024-07N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01301d65b070ca…
2024-06-18 03:08 UTC · 5 captures of this ZIP2024-06N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-011e350fbaab3a…
2024-05-31 18:47 UTC2024-05N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-018072bd15b7f6…
2022-06-29 02:47 UTC · 2 captures of this ZIP2022-06N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-015c6f7cd8ea54…
2022-04-08 23:34 UTC2022-04N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-015d02ea3f76ae…
2022-04-04 05:41 UTC2022-04N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-014b0b4de00fa7…
2019-12-13 00:20 UTC2019-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-0174a2ff9319b5…
2022-03-09 01:35 UTC2022-03N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01bb7c543d1eb4…
2021-12-28 21:50 UTC2021-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01782e0a99824c…
2021-05-05 16:15 UTC · 3 captures of this ZIP2021-05N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-0187673890dc5c…
2021-03-12 10:30 UTC2021-03N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-015aa47cf7b7d7…
2020-12-22 03:56 UTC2020-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-018869cabd3fbd…
2020-11-12 02:37 UTC2020-11N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01c0c555d07b60…
2019-12-14 00:12 UTC2019-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-013f01610625f2…
2019-09-15 20:21 UTC2019-09N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01b00525d2431f…
2019-07-19 19:46 UTC2019-07N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01ea99ee380514…
2024-03-16 18:09 UTC · 4 captures of this ZIP2024-03N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-016a51e52b5d6a…
2024-02-18 07:12 UTC2024-02N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-011c564ffb4f44…
2023-12-20 04:57 UTC2023-12N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01ea1830bbd6c7…
2023-11-28 05:40 UTC · 2 captures of this ZIP2023-11N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01a72a2bbeb626…
2023-10-25 00:34 UTC · 2 captures of this ZIP2023-10N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-019b2671bbb829…
2023-07-15 15:27 UTC · 2 captures of this ZIP2023-07N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01a67488948f0b…
2023-06-13 01:57 UTC · 3 captures of this ZIP2023-06N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-013f0d92c62455…
2023-05-13 08:27 UTC2023-05N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-01053a50430f4f…
2023-01-26 05:58 UTC2023-01N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-013bdfa0b2c4d7…
2022-11-12 20:34 UTC · 5 captures of this ZIP2022-11N022281-001ZEGERID OTC20MG;1.1GMCAPSULE / ORALRLD, RS2009-12-013a93d1ddd44b…

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
Zegerid OTCOMEPRAZOLE, SODIUM BICARBONATERiley Consumer Care LLC1d764fc5-8eae-4fc9-a2e9-3f1954a3ac052025-12-24WarningsExact identifier
ndc (package): 82632-100-03
ndc (package): 82632-100-01
ndc (product): 82632-100
ndc11 (package): 82632010003
ndc11 (package): 82632010001
spl id: 7e277414-7482-4bfc-935b-aee179357434
spl set id: 1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05

Reported adverse events (FAERS/openFDA)#

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