Prescription and over-the-counter medicine
Omeprazole and sodium bicarbonate Brand names: Zegerid, Konvomep
Omeprazole and sodium bicarbonate (Zegerid) is a prescription and over-the-counter medicine with an FDA approval on record since 2004. FDA's NDC Directory lists it from 20 generic labelers, and pharmacies paid $7.90 per packet (Omeprazole-bicarb 40-1,680 packet) in the October 7, 2026 NADAC survey; its other strengths are brand-only, $1.76 per mL (Konvomep 2-84 mg/mL oral suspension).
- Generic listed
Check it at the source: the omeprazole and sodium bicarbonate FDA label on DailyMed (effective December 24, 2025, Riley Consumer Care LLC); the NDA 21636 record on Drugs@FDA; every omeprazole and sodium bicarbonate label on DailyMed.
Highlights of the record
FDA label of December 24, 2025; NDC Directory, Drugs@FDA and Orange Book, October 8, 2026; NADAC October 7, 2026
Used for
From the label: indications and usagetreats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn.
Forms and strengths
- 20 mg / 1100 mg
- 20 mg / 1680 mg
- 40 mg / 1100 mg
- 40 mg / 1680 mg
Capsule; gelatin-coated capsule; powder for suspension; for suspension; kit.
On the market
- Earliest approval on file
- June 15, 2004 Zegerid, Salix; Drugs@FDA’s file, where older or withdrawn approvals can be missing
- Generic approvals
- 16 first May 25, 2010; 13 with a marketed status in Drugs@FDA
- Labelers listed (NDC)
- 22 of which 20 under generic applications, 3 under brand applications, repackagers included
- Last listed patent
- March 1, 2040 Konvomep for oral suspension; not a generic launch date
Supply and safety
- Pharmacy cost (NADAC)
- $7.90 per packet Omeprazole-bicarb 40-1,680 packet
- Shortage (FDA)
- No current entry
- Recalls by its makers (FDA)
- 5 since 2013 0 Class I among all firms' recalls; latest February 2, 2024
- FAERS reports
- 342,964 through July 30, 2026
What is omeprazole and sodium bicarbonate used for?
From the label: indications and usagetreats 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.
Conditions named in the indications of omeprazole and sodium bicarbonate's FDA labels, with every medicine labeled for each:
From other omeprazole and sodium bicarbonate labelsAcid reflux and ulcers: Use treats frequent heartburn (occurs 2 or more days a week) not intended for immediate relief of heartburn.
FDA pharmacologic class: Osmotic Laxative and Proton Pump Inhibitor.
Source: FDA drug label (Zegerid OTC), Riley Consumer Care LLC, effective December 24, 2025 (SPL set 1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05), via openFDA; the full label on DailyMed
What does the patient leaflet for omeprazole and sodium bicarbonate say first?
The FDA-approved Medication Guide or Patient Information that comes with the medicine, in its own words.
From the patient leaflet: What is the most important information I should know about Omeprazole and Sodium Bicarbonate capsules?Omeprazole and Sodium Bicarbonate capsules may help your acid-related symptoms, but you could still have serious stomach problems. Talk with your doctor. Omeprazole and Sodium Bicarbonate capsules can cause serious side effects, including: A type of kidney problem (acute tubulointerstitial nephritis). Some people who take proton pump inhibitor (PPI) medicines, including Omeprazole and Sodium Bicarbonate capsules, may develop a kidney problem called acute tubulointerstitial nephritis that can happen at any time during treatment with Omeprazole and Sodium Bicarbonate capsules. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine. Omeprazole and Sodium Bicarbonate capsules contains sodium bicarbonate. Long-term use of bicarbonate with calcium or milk can cause a condition called “milk-alkali syndrome”. Long-term use of sodium bicarbonate can cause a condition called “systemic alkalosis”. Talk to your doctor about any questions you may have. Too much sodium can cause swelling and weight gain. Tell your doctor if you are on a low-sodium diet or if you have Bartter’s Syndrome (a rare kidney disorder). Tell your doctor right away if you have confusion, shaking hands, dizziness, muscle twitching, nausea, vomiting, and numbness or tingling in the face, arms, or legs. Diarrhea caused by an infection (Clostridium difficile) in your intestines. Call your doctor right away if you have watery stools or stomach pain that does not go away. You may or may not have a fever. Bone fractures (hip, wrist, or spine). Bone fractures in the hip, wrist or spine may happen in people who take multiple daily doses of PPI medicines and for a long period of time (a year or longer). […]
From the patient leaflet: How should I store Omeprazole and Sodium Bicarbonate capsules?Omeprazole and Sodium Bicarbonate capsules comes in child resistant package. Store Omeprazole and Sodium Bicarbonate capsules at room temperature between 68°F to 77°F (20°C to 25°C). Keep Omeprazole and Sodium Bicarbonate capsules in a tightly closed container. Keep Omeprazole and Sodium Bicarbonate capsules in a dry place and out of light. Keep Omeprazole and Sodium Bicarbonate capsules and all medicines out of reach of children.
Source: FDA drug label (Omeprazole and Sodium Bicarbonate), Ajanta Pharma USA Inc., effective October 6, 2025 (SPL set cb657607-b038-47ee-b4e7-a5f419a14c33), via openFDA; the full label on DailyMed
Is there a generic for omeprazole and sodium bicarbonate (Zegerid)?
The FDA approved the first generic omeprazole and sodium bicarbonate on May 25, 2010. 16 generic applications are approved; 13 of them carry a current (not discontinued) marketing status in Drugs@FDA; that status is not evidence that the generic is on sale.
FDA's NDC Directory lists omeprazole and sodium bicarbonate from 20 labelers under a generic (ANDA) application and from 3 brand labelers. A listing means the company has registered the product for sale; it does not show that every pharmacy stocks it.
The Orange Book lists no patent for Zegerid Otc capsules; a patent listed only for Konvomep for oral suspension runs to March 1, 2040. A patent or exclusivity date is not the date a generic goes on sale: court cases and settlements move it either way.
- 2004 earliest approval on file
- 2010 first generic approved
- 2040 last listed patent
- red ticks recalls
Source: Drugs@FDA, FDA NDC Directory and the Orange Book (openFDA bulk files, October 8, 2026)
What do pharmacies pay for omeprazole and sodium bicarbonate (Zegerid)?
In CMS's NADAC survey of October 7, 2026, pharmacies paid $7.90 per packet (Omeprazole-bicarb 40-1,680 packet), down 22% from $10.15 on October 8, 2025. The chart's scale runs from the lowest to the highest price shown, not from zero. NADAC is what retail pharmacies paid their wholesalers, per unit, in CMS's monthly survey; what a patient pays depends on insurance and the pharmacy.
- Omeprazole-bicarb 40-1,680 packet (generic)
- Konvomep 2-84 mg/mL oral suspension (brand)
| Strength and form | Brand or generic | Pharmacy cost | 30 tablets, or one pen or vial | 12-month change |
|---|---|---|---|---|
| Omeprazole-bicarb 20-1,100 capsule | Generic | $0.629 per capsule | $18.86 | +6% |
| Omeprazole-bicarb 20-1,680 packet | Generic | $8.11 per packet | n/a | +15% |
| Omeprazole-bicarb 40-1,100 capsule | Generic | $0.562 per capsule | $16.87 | -16% |
| Omeprazole-bicarb 40-1,680 packet | Generic | $7.90 per packet | n/a | -22% |
| Konvomep 2-84 mg/mL oral suspension | Brand | $1.76 per mL | n/a | +1% |
Source: CMS National Average Drug Acquisition Cost (NADAC) survey, October 7, 2026: what retail pharmacies paid per unit; not a counter price
Has omeprazole and sodium bicarbonate been recalled?
The FDA's Enforcement Report lists 5 recalls naming omeprazole and sodium bicarbonate since 2013: 0 Class I (the most serious), 5 Class II, 0 Class III; 0 still ongoing. A recall names products and lots, not every product of the medicine.
| Started | Class | Company | Reason |
|---|---|---|---|
| February 2, 2024 | Class II | Bausch Health Companies, Inc. | Subpotent Drug: Out of specification for assay |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,100 mg may be potentially mislabeled as CYANOCOBALAMIN, Tablet, 1000 mcg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1,110 mg may be potentially mislabeled as ACETAMINOPHEN, CHEW Tablet, 80 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/110 mg may be potentially mislabeled as BENZOCAINE/MENTHOL, LOZENGE, 15 mg/2.6 mg, NDC … |
| July 2, 2013 | Class II | Aidapak Services, LLC | Labeling: Label Mixup; OMEPRAZOLE/SODIUM BICARBONATE, Capsule, 20 mg/1110 mg may be potentially mislabeled as LACTOBACILLUS GG, Capsule, NDC 49100036374 … |
Source: FDA Enforcement Report (drug recalls) via openFDA, through October 8, 2026
What does the omeprazole and sodium bicarbonate label say about other medicines?
The omeprazole and sodium bicarbonate label names 24 other medicines in its interaction, contraindication or warning sections. The sentences are the labels' own; a label lists what its studies and reports found, not every interaction.
| Medicine named | Section | What the label says |
|---|---|---|
| Atazanavir | drug interactions (prescription label) | Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with Omeprazole and Sodium Bicarbonate capsules are contraindicated [see Contraindications ()]. … |
| Cilostazol | drug interactions (prescription label) | Cilostazol Clinical Impact: Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro-cilostazol). Intervention: Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol. |
| Citalopram | drug interactions (prescription label) | Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation. Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram. |
| Clopidogrel | drug interactions (prescription label) | Clopidogrel Clinical Impact: Concomitant use of omeprazole 80 mg results in reduced plasma concentrations of the active metabolite of clopidogrel and a reduction in platelet inhibition. … Intervention: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules. Consider use of alternative anti-platelet therapy [see Warnings and Precautions ()]. |
| Cyanocobalamin | warnings and precautions (prescription label) | Avoid concomitant use of Omeprazole and Sodium Bicarbonate capsules. ( 5.8 ) Cyanocobalamin (Vitamin B-12) Deficiency: |
| Cyclosporine | drug interactions (prescription label) | Clinical Impact: There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (…). Intervention: Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with Omeprazole and Sodium Bicarbonate capsules. … |
| Dasatinib | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Diazepam | drug interactions (prescription label) | Diazepam Clinical Impact: Increased exposure of diazepam. Intervention: Monitor patients for increased sedation and reduce the dose of diazepam as needed. |
| Digoxin | drug interactions (prescription label) | Clinical Impact: Potential for increased exposure of digoxin. Intervention: Monitor digoxin concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See digoxin prescribing information. |
| Disulfiram | drug interactions (prescription label) | Clinical Impact: There have been clinical reports of interactions with other drugs metabolized via the cytochrome P450 system (…). Intervention: Monitor patients to determine if it is necessary to adjust the dosage of these other drugs when taken concomitantly with Omeprazole and Sodium Bicarbonate capsules. … |
| Erlotinib | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Itraconazole | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Ketoconazole | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Methotrexate | drug interactions (prescription label) | Methotrexate Clinical Impact: Concomitant use of omeprazole with methotrexate (primarily at high dose) may elevate and prolong serum concentrations of methotrexate and/or its metabolite hydroxymethotrexate, possibly leading to methotrexate toxicities. … Intervention: A temporary withdrawal of Omeprazole and Sodium Bicarbonate capsules may be considered in some patients receiving high-dose methotrexate. |
Every other medicine the omeprazole and sodium bicarbonate label names
| Medicine named | Section | What the label says |
|---|---|---|
| Mycophenolate mofetil | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Mycophenolic acid | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. … receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic acid (MPA), possibly due to a decrease in MMF solubility at an increased gastric pH. … |
| Nelfinavir | drug interactions (prescription label) | Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … capsules. See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules. See prescribing information for nelfinavir. … |
| Nilotinib | drug interactions (prescription label) | Clinical Impact: Omeprazole can reduce the absorption of other drugs due to its effect on reducing intragastric acidity. Intervention: Mycophenolate mofetil (MMF): Co-administration of omeprazole in healthy subjects and in transplant patients receiving MMF has been reported to reduce the exposure to the active metabolite, mycophenolic … |
| Phenytoin | drug interactions (prescription label) | Phenytoin Clinical Impact: Potential for increased exposure of phenytoin. Intervention: Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for phenytoin. |
| Rifampin | drug interactions (prescription label) | Clinical Impact: Decreased exposure of omeprazole when used concomitantly with strong inducers. Intervention: St. John’s wort, rifampin: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules [see Warnings and Precautions ( 5.10 )]. … |
| Rilpivirine | drug interactions (prescription label) | Antiretrovirals Clinical Impact: The effect of PPIs on antiretroviral drugs is variable. The clinical importance and the mechanisms behind these interactions are not always known. … Intervention: Rilpivirine-containing products: Concomitant use with Omeprazole and Sodium Bicarbonate capsules are contraindicated [see Contraindications ()]. … |
| Tacrolimus | drug interactions (prescription label) | Tacrolimus Clinical Impact: Potential for increased exposure of tacrolimus, especially in transplant patients who are intermediate or poor metabolizers of CYP2C19. Intervention: Monitor tacrolimus whole blood concentrations. Dose adjustment may be needed to maintain therapeutic drug concentrations. See prescribing information for tacrolimus. |
| Voriconazole | drug interactions (prescription label) | CYP2C19 or CYP3A4 Inhibitors Clinical Impact: Increased exposure of omeprazole. Intervention: Voriconazole: Dosage adjustment of Omeprazole and Sodium Bicarbonate capsules is not required. |
| Warfarin | drug interactions (prescription label) | Clinical Impact: Increased INR and prothrombin time in patients receiving PPIs, including omeprazole, and warfarin concomitantly. Increases in INR and prothrombin time may lead to abnormal bleeding and even death. Intervention: Monitor INR and prothrombin time and adjust the dose of warfarin, if needed, to maintain target INR range. |
Check omeprazole and sodium bicarbonate against other medicines
Source: FDA drug label (Zegerid OTC), Riley Consumer Care LLC, effective December 24, 2025 (SPL set 1d764fc5-8eae-4fc9-a2e9-3f1954a3ac05), via openFDA; the full label on DailyMed
What do FAERS reports show for omeprazole and sodium bicarbonate?
The FDA Adverse Event Reporting System holds 342,964 reports that list omeprazole and sodium bicarbonate among the medicines taken, through July 30, 2026, each a report of something that happened, not proof the medicine caused it; 31,161 are coded as a death and 125,920 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is.
Reports received each year
The most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026
What else is labeled for the same conditions as omeprazole and sodium bicarbonate?
19 other medicines are given the same way (oral) and in the same FDA class as omeprazole and sodium bicarbonate or labeled mainly for the same use (acid reflux and ulcers), the same class first. Acid reflux and ulcers lists all 27 medicines labeled for it, by any route. The first 8 are below. They are listed as records, not as substitutes: whether one can replace another is a prescriber's decision.
| Medicine | Shared indication | Generic labelers (oral) | Pharmacy cost | Shortage |
|---|---|---|---|---|
| Esomeprazole | Acid reflux and ulcers | 117 labelers | $0.145 per capsule 20 mg capsule | No current entry |
| Pantoprazole | Acid reflux and ulcers | 52 labelers | $0.0358 per tablet 40 mg tablet | No current entry |
| Lansoprazole | Acid reflux and ulcers | 59 labelers | $0.106 per capsule 30 mg capsule | No current entry |
| Calcium carbonate and famotidine and magnesium hydroxide | Acid reflux and ulcers | 20 labelers | $0.258 per tablet Acid reducer complete tablet chewable | No current entry |
| Rabeprazole | Acid reflux and ulcers | 20 labelers | $0.224 per tablet 20 mg tablet | No current entry |
| Dexlansoprazole | Acid reflux and ulcers | 9 labelers | $3.71 per capsule 60 mg capsule | No current entry |
| Esomeprazole and naproxen | Acid reflux and ulcers | 10 labelers | $1.96 per unit 500-20 mg | No current entry |
| Calcium carbonate | Acid reflux and ulcers | none listed | $0.0315 per tablet 750 mg tablet chewable | No current entry |
Every medicine labeled for the same conditions as omeprazole and sodium bicarbonate
Source: FDA drug labels (indications), NDC Directory, NADAC of October 7, 2026, FDA shortages (October 8, 2026)
What next?
- Alternatives to omeprazole and sodium bicarbonate
- 19 medicines for the same use
- Other osmotic laxatives
- the pharmacologic class, with prices and generics
- Omeprazole and sodium bicarbonate side effects
- the label's list beside FAERS reports
- Check an interaction
- what two or more labels say about each other