NDC 72189-0568-30 — Omeprazole/Sodiium Bicarbonate 40 mg; 1100 mg

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 72189-568-30

Product NDC 72189-568

11-digit billing NDC 72189056830

NCPDP billing unit EA — each (per item)

RxCUI 616541

UNII KG60484QX9, 8MDF5V39QO

Application # ANDA204228

SPL Set ID 1f7f63c1-17c2-9a05-e063-6394a90abc6f

Established class (EPC) Proton Pump Inhibitor

Mechanism of action Proton Pump Inhibitors; Cytochrome P450 2C19 Inhibitors

DEA schedule Non-controlled

Marketing category ANDA

Marketing status On market

FDA listing status Listed (active directory)

Marketing start 2024-08-12

Route ORAL

Dosage form CAPSULE

Substance OMEPRAZOLE; SODIUM BICARBONATE

TE code (Orange Book) AB · RLD · RS

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 060472

GCN 26633

HICL code 033512

Ingredient (HICL) Omeprazole/Sodium Bicarbonate

HIC1 code D

Therapeutic class — broad (HIC1) Biliary System/Gastro-Intestinal System

HIC2 code D4

Therapeutic class — intermediate (HIC2) Drugs Acting Principally On The Alimentary Tract

HIC3 code D4J

Therapeutic class — specific (HIC3) Proton-Pump Inhibitors

AHFS code 56:28.36.00

AHFS class Proton-Pump Inhibitors

FDB label name OMEPRAZOLE-BICARB 40-1,100 CAP

FDB brand name Omeprazole-Sodium Bicarbonate

Legend status F — Federal legend — prescription drug or device

Quick answers

GSN (GCN sequence number): 060472
GCN: 26633
HICL (First Databank): 033512
AHFS class code: 56:28.36.00
RxCUI (RxNorm): 616541

Why two NDCs? The FDA registers this code as 72189-568-30 — a 5-3-2 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the product segment → 72189-0568-30. Same drug, same package — only the format differs.

Where does this data come from?

Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026
RxNorm (NLM RxNav) · catalog refreshed Oct 1, 2026
Medi-Span GPI (licensed)
First Databank (licensed) · refreshed Oct 1, 2026

RxNorm drug class

This medicine belongs to the Salt solutions class.

Drug family (ATC) Salt solutions, Electrolyte solutions

Where does this data come from?

Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

RxClass (NLM) · catalog refreshed Oct 1, 2026

Clinical

Label name OMEPRAZOLE-BICARB 40-1,100 CAP Ingredient Omeprazole/Sodium Bicarbonate

📖 What it is MedlinePlus · NLM

Prescription omeprazole is used alone or with other medications to treat the symptoms of gastroesophageal reflux disease (GERD), a condition in which backward flow of acid from the stomach causes heartburn and possible injury of the esophagus (the tube between the throat and stomach) in adults and children 1 year of age and older. Prescription omeprazole is used to treat damage from GERD in adults and children 1 month of age and older. Prescription omeprazole is used to allow the esophagus to heal and prevent further damage to the esophagus in adults and children 1 year of age and older with G...

Read the full MedlinePlus article ↗

📗 Our plain-language guide HelloPharmacist

It lowers stomach acid. Prescription versions treat ulcers, GERD and erosive esophagitis, and over-the-counter versions treat frequent heartburn in adults. Zegerid oral suspension...
Take it once a day, at least 1 hour before eating, usually in the morning. Swallow capsules whole with water and don’t chew, crush or open them. If you use the powder, mix it in 2...
Use it for 14 days. You can repeat a course every 4 months if needed. If you need it longer or more often, talk to a doctor first.
How long can I use the over-the-counter version?

📖 Read our full Omeprazole / Sodium Bicarbonate guide →

Patient education

📘 MedlinePlus patient leaflet ↗

Supplement & herbal interactions

🌿 Drug–supplement interaction checker →

Where does this data come from?

Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

MedlinePlus (NLM) · refreshed Oct 1, 2026
FDA label on DailyMed · label index refreshed Oct 1, 2026

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price system	Per each	Per package
Retail pharmacies payNADAC · weekly	Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo	No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · Q2 2026	$1.66	$49.80 / 30 capsules

Where does this data come from?

NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

CMS NADAC weekly file
CMS ASP pricing files · refreshed Sep 20, 2026
CMS Medicaid State Drug Utilization Data · refreshed Oct 2, 2026
CMS Part D plan pricing files · refreshed Sep 24, 2026
VA National Acquisition Center price file

Packaging — all sizes for this product

Package NDC	Description	Marketing start	Marketing end	Status
72189-0568-30 You're viewing this Main listing	30 CAPSULE in 1 BOTTLE	2024-08-12	—	Active

Therapeutic equivalents

Product	Labeler	Pack	NADAC/unit	TE	Status	Price vs. this
Omeprazole and Sodium Bicarbonate 40 mg/1; 1100 mg 27241-0032-03	Ajanta	30 capsules	$0.562	AB	Availability likely	—
omeprazole sodium bicarbonate 40 mg/1; 1100 mg 69097-0914-02	Cipla	30 capsules	$0.562	AB	Availability likely	—
Omeprazole/Bicarbonate 40 mg/1; 1100 mg 69367-0196-30	Westminster	30 capsules	$0.562	AB	Availability likely	—
Omeprazole and Sodium Bicarbonate 40 mg/1; 1100 mg 68682-0104-30	Oceanside	30 capsules	$0.643	—	FDA listed	—
Omeprazole and Sodium Bicarbonate 40 mg/1; 1100 mg 50228-0364-05	ScieGen	500 capsules	—	AB	FDA listed	—
Omeprazole, Sodium bicarbonate 40 mg/1; 1100 mg 53041-0663-77	Guardian	30 capsules	—	AB	FDA listed	—
Zegerid 40 mg/1; 1100 mg 68012-0104-05	Santarus,	5 capsules	—	—	FDA listed	—
Omeprazole/Bicarbonate 40 mg/1; 1100 mg 71205-0985-30	Proficient	30 capsules	—	AB	FDA listed	—
Omeprazole/Sodiium Bicarbonate 40 mg/1; 1100 mgthis 72189-0568-30	Direct_rx	30 capsules	—	AB	FDA listed	—
Omeprazole and Sodium Bicarbonate 40 mg/1; 1100 mg 85509-1032-01	PHOENIX	15 capsules	—	AB	FDA listed	—

About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.

Where does this data come from?

Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

FDA openFDA NDC Directory · synced Oct 1, 2026
FDA Orange Book · refreshed Sep 3, 2026
CMS NADAC weekly file

Availability & generic status

🏛️

2024

On the market since

Aug 2024

📍

2026

Currently FDA-listed

2 years listed

🔓

·

Generic on the market

this product is a generic

✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

Where does this data come from?

Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

FDA Orange Book · refreshed Sep 3, 2026

What it looks like

Color white

ShapeCapsule

ImprintOM40;ap

Size23 mm

ScoringNot scored

One label can cover several strengths, so colors may be combined — always confirm a loose pill against the dispensed prescription label or a pharmacist.

Where does this data come from?

Physical description (imprint, shape, color, scoring, coating) from this product’s FDA Structured Product Labeling (SPL), mirrored from DailyMed / openFDA.

FDA label on DailyMed · label index refreshed Oct 1, 2026

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

UNII M28OL1HH48
Croscarmellose sodium is a plant-based substance derived from cellulose. It acts as a disintegrant, helping tablets and capsules break down quickly in the digestive system so the medicine can be absorbed.
UNII XM0M87F357
A dark iron oxide compound that gives medicines their black or dark color. It's used as a colorant in tablets and capsules to help identify the product and make it visually distinctive.
UNII WZH3C48M4T
Potassium hydroxide is a strong alkaline chemical used in medicines to adjust and maintain the pH level of liquid formulations, helping keep the product stable and the active ingredients effective.
UNII 6DC9Q167V3
Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.
UNII 46N107B71O
Shellac is a natural resin secreted by the lac beetle. It's used as a coating on tablets and capsules to control how quickly the medicine dissolves and to improve appearance and stability.
UNII 7CV7WJK4UI
Sodium stearyl fumarate is a synthetic compound made from stearyl alcohol and fumaric acid. It acts as a lubricant and glidant in tablets and capsules, helping ingredients flow smoothly during manufacturing and preventing sticking.

6 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?

Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

FDA label on DailyMed · label index refreshed Oct 1, 2026
FDA openFDA NDC Directory · synced Oct 1, 2026

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?

No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.

Why might an inactive ingredient be missing?

Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.

Can inactive ingredients matter?

Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerDirect_rx

Application holderAJANTA PHARMA LTD

FDA applicationANDA204228 (ANDA)

Labeler code72189

First marketedAug 2024

Product typeHuman Prescription Drug

Portfolio352 products on file

🔎 All NDCs from Direct_rx

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).

Where does this data come from?

Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

FDA openFDA NDC Directory · synced Oct 1, 2026
Drugs@FDA

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Jump with a chip, search within the label, or expand everything.

🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🆘 Overdosage 🧬 Clinical Pharmacology 📦 How Supplied / Storage and Handling 📦 Storage and Handling 📋 Description 💬 Medication Guide

🎯 Indications and Usage 162 words ▾

Omeprazole and Sodium Bicarbonate capsules are indicated in adults for the: short-term treatment of active duodenal ulcer. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. short-term treatment (4 to 8 weeks) of active benign gastric ulcer. treatment of heartburn and other symptoms associated with GERD for up to 4 weeks. short-term treatment (4 to 8 weeks) of EE due to acid-mediated GERD which has been diagnosed by endoscopy in adults.

The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established. If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate capsules may be considered. maintenance of healing of EE due to acid-mediated GERD.

Controlled studies do not extend beyond 12 months.

⏱️ Dosage and Administration ~2 min read ▾

2.1Important Administration Instructions Omeprazole and Sodium Bicarbonate is available as a capsule in 20 mg and 40 mg strengths of omeprazole for adult use. All recommended doses throughout the labeling are based upon omeprazole. The sodium content of Omeprazole and Sodium Bicarbonate capsules should be taken into consideration when prescribing this product [see Warnings and Precautions (5.3)]: Omeprazole and Sodium Bicarbonate capsule: each 20 mg and 40 mg capsule contains 1,100 mg (13 mEq) of sodium bicarbonate.

The total content of sodium in each capsule is 304 mg. Due to the sodium bicarbonate content of Omeprazole and Sodium Bicarbonate capsules: Do not substitute two 20 mg Omeprazole and Sodium Bicarbonate capsules with one 40 mg Omeprazole and Sodium Bicarbonate capsule.

2.2Dosage Regimen The recommended dosage regimen by indication in adults of Omeprazole and Sodium Bicarbonate capsules is summarized in Table 1. All recommended dosages are based upon omeprazole content. Table 1: Recommended Dosage Regimen of Omeprazole and Sodium Bicarbonate Capsules in Adults by Indication 1.

Most patients heal within 4 weeks. Some patients may require an additional 4 weeks of therapy [see Clinical Studies (14.1)]. 2.The efficacy of Omeprazole and Sodium Bicarbonate capsules used for longer than 8 weeks in patients with EE has not been established.

If a patient does not respond to 8 weeks of treatment, an additional 4 weeks of treatment may be given. If there is recurrence of EE or GERD symptoms (e.g., heartburn), additional 4 to 8-week courses of Omeprazole and Sodium Bicarbonate capsules may be considered. Indication Dosage of Omeprazole and Sodium Bicarbonate capsules Treatment Duration Treatment of Active Duodenal Ulcer 20 mg once daily 4 weeks1,2 Treatment of Active Benign Gastric Ulcer 40 mg once daily 4 to 8 weeks Treatment of Symptomatic GERD 20 mg once daily Up to 4 weeks Treatment of EE due to Acid-Mediated GERD 20 mg once daily 4 to 8 weeks2 Maintenance of Healing of EE due to Acid-Mediated GERD 20 mg once daily Controlled studies do not extend beyond 12 months.

2.3Preparation and Administration Omeprazole and Sodium Bicarbonate Capsules Swallow capsules intact with water. Do not open the capsule and do not administer with liquids other than water. Take on an empty stomach at least one hour before a meal [see Clinical Pharmacology (12.3)].

💊 Dosage Forms and Strengths 74 words ▾

Omeprazole and Sodium Bicarbonate is available as: Capsules 20 mg:Each opaque, hard gelatin, white/light orange capsule, with ‘OM 20’ imprint on body and ‘ap’ logo imprint on cap with black color ink, contains 20 mg omeprazole and 1,100 mg sodium bicarbonate. 40 mg:Each opaque, hard gelatin, white/reddish pink capsule, with ‘OM 40’ imprint on body and ‘ap’ logo imprint on cap with black color ink, contains 40 mg omeprazole and 1,100 mg sodium bicarbonate.

⛔ Contraindications 65 words ▾

Omeprazole and Sodium Bicarbonate capsules are contraindicated in patients with known hypersensitivity to substituted benzimidazoles or to any components of the formulation. Hypersensitivity reactions may include anaphylaxis, anaphylactic shock, angioedema, bronchospasm, acute tubulointerstitial nephritis, and urticaria [see Warnings and Precautions (5.2), Adverse Reactions (6.2)]. Proton pump inhibitors (PPIs), including Omeprazole and Sodium Bicarbonate capsules, are contraindicated in patients receiving rilpivirine containing products[see Drug Interactions (7)].

⚠️ Warnings and Cautions ~3 min read ▾

5.1Presence of Gastric Malignancy In adults, symptomatic response to therapy with Omeprazole and Sodium Bicarbonate capsules does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing in adult patients who have a suboptimal response or an early symptomatic relapse after completing treatment with a proton pump inhibitor (PPI). In older patients, also consider an endoscopy.

5.2Acute Tubulointerstitial Nephritis Acute tubulointerstitial nephritis (TIN) has been observed in patients taking PPIs and may occur at any point during PPI therapy. Patients may present with varying signs and symptoms from symptomatic hypersensitivity reactions to non-specific symptoms of decreased renal function (e.g., malaise, nausea and anorexia). In reported case series, some patients were diagnosed on biopsy and in the absence of extra-renal manifestations (e.g., fever, rash or arthralgia).

Discontinue Omeprazole and Sodium Bicarbonate capsules and evaluate patients with suspected acute TIN [see Contraindications (4)].

5.3Sodium Bicarbonate Buffer Content Each 20 mg and 40 mg Omeprazole and Sodium Bicarbonate capsule contains 1,100 mg (13 mEq) of sodium bicarbonate. The total content of sodium in each capsule is 304 mg. Chronic administration of bicarbonate with calcium or milk can cause milk-alkali syndrome.

Chronic use of sodium bicarbonate may lead to systemic alkalosis, and increased sodium intake can produce edema and weight gain. The sodium content of Omeprazole and Sodium Bicarbonate products should be taken into consideration when administering to patients on a sodium-restricted diet or those at risk for developing congestive heart failure. Avoid Omeprazole and Sodium Bicarbonate capsules in patients with Bartter’s syndrome, hypokalemia, hypocalcemia, and problems with acid-base balance.

5.4Clostridium difficile-Associated Diarrhea Published observational studies suggest that PPI therapy like Omeprazole and Sodium Bicarbonate capsules may be associated with an increased risk of Clostridium difficile-associated diarrhea, especially in hospitalized patients. This diagnosis should be considered for diarrhea that does not improve [see Adverse Reactions (6.2)]. Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

5.5Bone Fracture Several published observational studies suggest that proton pump inhibitor (PPI) therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist, or spine. The risk of fracture was increased in patients who received high-dose, defined as multiple daily doses, and long-term PPI therapy (a year or longer). Patients should use the lowest dose and shortest duration of PPI therapy appropriate to the condition being treated.

Patients at risk for osteoporosis-related fractures should be managed according to the established treatment guidelines [see Dosage and Administration (2.2) and Adverse Reactions (6.2)].

5.6Severe Cutaneous Adverse Reactions Severe cutaneous adverse reactions, including Stevens-Johnson syndrome (SJS) and toxic epidermal necrolysis (TEN), drug reaction with eosinophilia and systemic symptoms (DRESS), and acute generalized exanthematous pustulosis (AGEP) have been reported in association with the use of PPIs [see Adverse Reactions (6.2)]. Discontinue Omeprazole and Sodium Bicarbonate capsules at the first signs or symptoms of severe cutaneous adverse reactions or other signs of hypersensitivity and consider further evaluation.

5.7Cutaneous and Systemic Lupus Erythematosus Cutaneous lupus erythematosus (CLE) and systemic lupus erythematosus (SLE) have been reported in patients taking PPIs, including omeprazole. These events have occurred as both new onset and an exacerbation of existing autoimmune disease. The majority of PPI-induced lupus erythematosus cases were CLE. The most common form of CLE reported in patients treated with PPIs was subacute CLE (SCLE…

🤒 Adverse Reactions ~3 min read ▾

The following serious adverse reactions are described below and elsewhere in labeling: Acute Tubulointerstitial Nephritis [see Warnings and Precautions (5.2)] Clostridium difficile-Associated Diarrhea [see Warnings and Precautions (5.4)] Bone Fracture [see Warnings and Precautions (5.5)] Severe Cutaneous Adverse Reactions [see Warnings and Precautions (5.6)] Cutaneous and Systemic Lupus Erythematosus [see Warnings and Precautions (5.7)] Cyanocobalamin (Vitamin B-12) Deficiency [see Warnings and Precautions (5.9)] Hypomagnesemia and Mineral Metabolism [see Warnings and Precautions (5.10)] Fundic Gland Polyps [see Warnings and Precautions (5.14)]

6.1Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The safety of Omeprazole and Sodium Bicarbonate capsules has been established, in part, based on oral studies of an oral delayed-release omeprazole product. Clinical Trials with Omeprazole In the U.S. clinical trial population of 465 adult patients, the adverse reactions summarized in Table 3 were reported to occur in 1% or more of patients on therapy with omeprazole.

Table 3: Adverse Reactions Occurring in 1% or More of Adult Patients in US Clinical Trials of Omeprazole Therapy Omeprazole % (n = 465) Placebo % (n = 64) Ranitidine % (n = 195) Headache 7 6 8 Diarrhea 3 3 2 Abdominal Pain 2 3 3 Nausea 2 3 4 Upper Respiratory Infection (URI) 2 2 3 Dizziness 2 0 3 Vomiting 2 5 2 Rash 2 0 0 Constipation 1 0 0 Cough 1 0 2 Asthenia 1 2 2 Back Pain 1 0 1 Table 4 summarizes the adverse reactions that occurred in 1% or more of omeprazole-treated patients from international double-blind and open-label clinical trials in which 2,631 patients and subjects received omeprazole.

Table 4: Adverse Reactions Occurring in 1% or More of Adult Patients in International Clinical Trials of Omeprazole Therapy Omeprazole % (n = 2631) Placebo % (n = 120) Abdominal Pain 5.2

3.3Nausea 4.0

6.7Diarrhea 3.7

2.5Vomiting 3.2

10.0Headache 2.9

2.5Flatulence 2.7

5.8Acid Regurgitation 1.9

3.3Constipation 1.5

0.8Asthenia 1.3 0.8

6.2Postmarketing Experience The following adverse reactions have been identified during post-approval use of omeprazole and sodium bicarbonate. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. Omeprazole Body as a Whole: Hypersensitivity reactions, including anaphylaxis, anaphylactic shock, angioedema, bronchospasm, urticaria (see also Skin below), fever, pain, fatigue, malaise, and systemic lupus erythematosus.

Cardiovascular: Chest pain or angina, tachycardia, bradycardia, palpitation, elevated blood pressure, and peripheral edema. Gastrointestinal: Pancreatitis (some fatal), anorexia, irritable colon, flatulence, fecal discoloration, esophageal candidiasis, mucosal atrophy of the tongue, dry mouth, stomatitis, abdominal swelling and fundic gland polyps. Gastroduodenal carcinoids have been reported in patients with Zollinger-Ellison syndrome on long-term treatment with omeprazole.

This finding is believed to be a manifestation of the underlying condition, which is known to be associated with such tumors. Hepatic: Mild and, rarely, marked elevations of liver function tests [ALT (SGPT), AST (SGOT), γ-glutamyl transpeptidase, alkaline phosphatase, and bilirubin (jaundice)]. In rare instances, overt liver disease has occurred, including hepatocellular, cholestatic, or mixed hepatitis, liver necrosis (some fatal), hepatic failure (some fatal), and hepatic encephalopathy.

Infections and Infestations: Clostridium difficile-associated diarrhea. Metabolism and Nutritional Disorders: Hypomagnesemia, hypocalcemia, hypokalemia [see Warnings and Precautions (5.10…

🔄 Drug Interactions ~2 min read ▾

Tables 6 and 7 include drugs with clinically important drug interactions and interaction with diagnostics when administered concomitantly with omeprazole and instructions for preventing or managing them. Consult the labeling of concomitantly used drugs to obtain further information about interactions with PPIs. Table 6: Clinically Relevant Interactions Affecting Drugs Co-Administered with Omeprazole and Interaction with Diagnostics 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. Decreased exposure of some antiretroviral drugs (e.g., rilpivirine, atazanavir and nelfinavir) when used concomitantly with omeprazole may reduce antiviral effect and promote the development of drug resistance [see Clinical Pharmacology (12.3)]. Increased exposure of other antiretroviral drugs (e.g., saquinavir) when used concomitantly with omeprazole may increase toxicity [see Clinical Pharmacology (12.3)].

There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-containing products: Concomitant use with Omeprazole and Sodium Bicarbonate capsules are contraindicated [see Contraindications (4)]. Atazanavir: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules.

See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules. See prescribing information for nelfinavir.

Saquinavir: See the prescribing information for saquinavir for monitoring of potential saquinavir-related toxicities. Other antiretrovirals: See prescribing information for specific antiretroviral drugs. Warfarin 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. 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.

No formal drug interaction studies of high-dose methotrexate with PPIs have been conducted [see Warnings and Precautions (5.12)]. Intervention: A temporary withdrawal of Omeprazole and Sodium Bicarbonate capsules may be considered in some patients receiving high-dose methotrexate. CYP2C19 Substrates (e.g., clopidogrel, citalopram, cilostazol, phenytoin, diazepam) 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 [see Clinical Pharmacology (12.3)].

There are no adequate combination studies of a lower dose of omeprazole or a higher dose of clopidogrel in comparison with the approved dose of clopidogrel. Intervention: Avoid concomitant use with Omeprazole and Sodium Bicarbonate capsules. Consider use of alternative anti-platelet therapy [see Warnings and Precautions (5.7)].

Citalopram Clinical Impact: Increased exposure of citalopram leading to an increased risk of QT prolongation [see Clinical Pharmacology (12.3)]. Intervention: Limit the dose of citalopram to a maximum of 20 mg per day. See prescribing information for citalopram.

Cilostazol Clinical Impact: Increased exposure of one of the active metabolites of cilostazol (3,4-dihydro cilostazol) [see Clinical Pharmacology (12.3)]. Intervention: Reduce the dose of cilostazol to 50 mg twice daily. See prescribing information for cilostazol.

Phenytoin Clinical Impact: Potential for increased exposure of phenytoin. Intervention: Monitor phenytoin serum concentrations. Dose adjustment may be needed to maintain therapeut…

👥 Use in Specific Populations ~3 min read ▾

8.1Pregnancy Risk Summary There are no adequate and well-controlled studies with Omeprazole and Sodium Bicarbonate capsules in pregnant women. Omeprazole and Sodium Bicarbonate capsules contains omeprazole and sodium bicarbonate. Omeprazole There are no adequate and well-controlled studies with omeprazole in pregnant women.

Available epidemiologic data fail to demonstrate an increased risk of major congenital malformations or other adverse pregnancy outcomes with first trimester omeprazole use. Reproduction studies in rats and rabbits resulted in dose-dependent embryo-lethality at omeprazole doses that were approximately 3.4 to 34 times an oral human dose of 40 mg (based on a body surface area for a 60 kg person). Teratogenicity was not observed in animal reproduction studies with administration of oral esomeprazole (an enantiomer of omeprazole) magnesium in rats and rabbits during organogenesis with doses about 68 times and 42 times, respectively, an oral human dose of 40 mg esomeprazole or 40 mg omeprazole (based on body surface area for a 60 kg person).

Changes in bone morphology were observed in offspring of rats dosed through most of pregnancy and lactation at doses equal to or greater than approximately 34 times an oral human dose of 40 mg esomeprazole or 40 mg omeprazole. When maternal administration was confined to gestation only, there were no effects on bone physeal morphology in the offspring at any age (see Data). Sodium Bicarbonate Available data with sodium bicarbonate use in pregnant women are insufficient to identify a drug associated risk of major birth defects or miscarriage.

Published animal studies report that sodium bicarbonate administered to rats, mice or rabbits during pregnancy did not cause adverse developmental effects in offspring. The estimated background risks of major birth defects and miscarriage for the indicated population are unknown. All pregnancies have a background risk of birth defect, loss or other adverse outcomes.

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively. Data Human Data There are no adequate and well-controlled studies with Omeprazole and Sodium Bicarbonate capsules in pregnant women. Four published epidemiological studies compared the frequency of congenital abnormalities among infants born to women who used omeprazole during pregnancy with the frequency of abnormalities among infants of women exposed to H2-receptor antagonists or other controls.

A population-based retrospective cohort epidemiological study from the Swedish Medical Birth Register, covering approximately 99% of pregnancies, from 1995-99, reported on 955 infants (824 exposed during the first trimester with 39 of these exposed beyond first trimester, and 131 exposed after the first trimester) whose mothers used omeprazole during pregnancy. The number of infants exposed in utero to omeprazole that had any malformation, low birth weight, low Apgar score, or hospitalization was similar to the number observed in this population.

The number of infants born with ventricular septal defects and the number of stillborn infants was slightly higher in the omeprazole-exposed infants than the expected number in this population. A population-based retrospective cohort study covering all live births in Denmark from 1996-2009 reported on 1,800 live births whose mothers used omeprazole during the first trimester of pregnancy and 837,317 live births whose mothers did not use any PPI. The overall rate of birth defects in infants born to mothers with first trimester exposure to omeprazole was 2.9% and 2.6% in infants born to mothers not exposed to any PPI during the first trimester.

A retrospective cohort study reported on 689 pregnant women exposed to either H2-blockers or omeprazole in the first trimester (134 exposed to omeprazole) and 1,572 pregnant women unexposed to either during the first trimest…

🆘 Overdosage 150 words ▾

If over-exposure occurs, call your Poison Control Center at 1-800-222-1222 for current information on the management of poisoning or overdosage. Omeprazole Reports have been received of overdosage with omeprazole in humans. Doses ranged up to 2,400 mg (120 times the usual recommended clinical dose).

Manifestations were variable, but included confusion, drowsiness, blurred vision, tachycardia, nausea, vomiting, diaphoresis, flushing, headache, dry mouth, and other adverse reactions similar to those seen in clinical experience with the recommended dosage [see Adverse Reactions (6)]. Symptoms were transient, and no serious clinical outcome has been reported when omeprazole was taken alone. No specific antidote for omeprazole overdosage is known.

Omeprazole is extensively protein bound and is, therefore, not readily dialyzable. In the event of overdosage, treatment should be symptomatic and supportive. Sodium Bicarbonate Overdosage of sodium bicarbonate can cause electrolyte abnormalities (hypocalcemia, hypokalemia, hypernatremia), metabolic alkalosis, and seizures.

Institute supportive care and correct electrolyte abnormalities.

🧬 Clinical Pharmacology ~3 min read ▾

12.1Mechanism of Action Omeprazole belongs to a class of antisecretory compounds, the substituted benzimidazoles, that suppress gastric acid secretion by specific inhibition of the H+/K+ ATPase enzyme system at the secretory surface of the gastric parietal cell. Because this enzyme system is regarded as the acid (proton) pump within the gastric mucosa, omeprazole has been characterized as a gastric acidpump inhibitor, in that it blocks the final step of acid production. This effect is dose related and leads to inhibition of both basal and stimulated acid secretion irrespective of the stimulus.

12.2Pharmacodynamics Antisecretory Activity Results from a pharmacokinetic/pharmacodynamic (PK/PD) study of the antisecretory effect of repeated once-daily dosing of 40 mg and 20 mg of ZEGERID for oral suspension in healthy subjects are shown in Table 8 below. Table 8: Effect of ZEGERID for Oral Suspension on Intragastric pH, Day 7 1. P < 0.05 20 mg vs.

40 mg Once-Daily Dosage of ZEGERID for Oral Suspension Parameter 40 mg omeprazole and 1,680 mg sodium bicarbonate (n = 24) 20 mg omeprazole and 1,680 mg sodium bicarbonate (n = 28) % Decrease from Baseline for Integrated Gastric Acidity (mmol•hr/L) 84% 82% Coefficient of Variation 20% 24% % Time Gastric pH >41 (Hours)1 77% (18.6 h) 51% (12.2 h) Coefficient of Variation 27% 43% Median pH 5.2

4.2Coefficient of Variation 17% 37% Note: Values represent medians. All parameters were measured over a 24-hour period. Results from a separate PK/PD study of antisecretory effect on repeated once-daily dosing of 40 mg/1,100 mg and 20 mg/1,100 mg of Omeprazole and Sodium Bicarbonate capsules in healthy subjects show similar effects in general on the above three PD parameters as those for ZEGERID for oral suspension 40 mg/1,680 mg and 20 mg/1,680 mg, respectively.

The antisecretory effect lasts longer than would be expected from the very short (1 hour) plasma half-life, apparently due to irreversible binding to the parietal H+/K+ ATPase enzyme. Enterochromaffin-like (ECL) Cell Effects Human gastric biopsy specimens have been obtained from more than 3000 patients treated with omeprazole in long-term clinical trials. The incidence of ECL cell hyperplasia in these studies increased with time; however, no case of ECL cell carcinoids, dysplasia, or neoplasia has been found in these patients.

These studies are of insufficient duration and size to rule out the possible influence of long-term administration of omeprazole on the development of any premalignant or malignant conditions. Serum Gastrin Effects In studies involving more than 200 patients, serum gastrin levels increased during the first 1 to 2 weeks of once-daily administration of therapeutic doses of omeprazole in parallel with inhibition of acid secretion. No further increase in serum gastrin occurred with continued treatment.

In comparison with histamine H2-receptor antagonists, the median increases produced by 20 mg doses of omeprazole were higher (1.3 to 3.6-fold vs. 1.1- to 1.8-fold increase). Gastrin values returned to pretreatment levels, usually within 1 to 2 weeks after discontinuation of therapy.

Increased gastrin causes enterochromaffin-like cell hyperplasia and increased serum Chromogranin A (CgA) levels. The increased CgA levels may cause false positive results in diagnostic investigations for neuroendocrine tumors [see Warnings and Precautions (5.11)]. Other Effects Systemic effects of omeprazole in the central nervous system (CNS), cardiovascular and respiratory systems have not been found to date.

Omeprazole, given in oral doses of 30 or 40 mg for 2 to 4 weeks, had no effect on thyroid function, carbohydrate metabolism, or circulating levels of parathyroid hormone, cortisol, estradiol, testosterone, prolactin, cholecystokinin or secretin. No effect on gastric emptying of the solid and liquid components of a test meal was demonstrated after a single dose of omeprazole 90 mg. In healthy subjects, a single intravenous dose of omeprazo…

📦 How Supplied / Storage and Handling 97 words ▾

Omeprazole and Sodium Bicarbonate Capsules are supplied as Omeprazole and Sodium Bicarbonate Capsules NDC Strength Quantity Description 27241-031-03 20 mg omeprazole USP and 1,100 mg sodium bicarbonate USP Bottles of 30 capsules with child-resistant closure Opaque, hard gelatin, white/light orange capsule, with ‘OM 20’ imprint on body and ‘ap’ logo imprint on cap with black color ink 72189-568-30 40 mg omeprazole USP and 1,100 mg sodium bicarbonate USP Bottles of 30 capsules with child-resistant closure Opaque, hard gelatin, white/reddish pink capsule, with ‘OM 40’ imprint on body and ‘ap’ logo imprint on cap with black color ink

📦 Storage and Handling 32 words ▾

Storage Store at 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F) [see USP Controlled Room Temperature]. Keep container tightly closed. Protect from light and moisture.

📋 Description 191 words ▾

Omeprazole and Sodium Bicarbonate capsules are a combination of omeprazole, a proton-pump inhibitor, and sodium bicarbonate, an antacid. Omeprazole is a substituted benzimidazole, 5-methoxy-2-[[(4-methoxy-3,5-dimethyl-2-pyridinyl)methyl]sulfinyl]-1H-benzimidazole, a racemic mixture of two enantiomers that inhibits gastric acid secretion. Its empirical formula is C17H19N3O3S, with a molecular weight of 345.42.

The structural formula is: [STR] Omeprazole is a white to off-white crystalline powder which melts with decomposition at about 155ºC. It is a weak base, freely soluble in ethanol and methanol, and slightly soluble in acetone and isopropanol and very slightly soluble in water. The stability of omeprazole is a function of pH; it is rapidly degraded in acid media but has acceptable stability under alkaline conditions.

Omeprazole and Sodium Bicarbonate capsules are supplied as immediate-release capsules. Each capsule contains either 40 mg or 20 mg of omeprazole USP and 1,100 mg of sodium bicarbonate USP with the following excipients: croscarmellose sodium and sodium stearyl fumarate. The black imprinting ink contains black iron oxide, propylene glycol, shellac, and potassium hydroxide.

Omeprazole and Sodium Bicarbonate capsules are immediate-release formulations that contain sodium bicarbonate which raises the gastric pH and thus protects omeprazole from acid degradation. Close

💬 Medication Guide ~3 min read ▾

Omeprazole and Sodium Bicarbonate (oh mep’ ra zole and soe’ dee um bye kar’ bo nate) Capsules, for oral use 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).

Tell your doctor if you have bone fracture, especially in the hip, wrist, or spine. Certain types of lupus erythematosus. Lupus erythematosus is an autoimmune disorder (the body’s immune cells attack other cells or organs in the body).

Some people who take PPI medicines, including Omeprazole and Sodium Bicarbonate capsules, may develop certain types of lupus erythematosus or have worsening of the lupus they already have. Call your doctor right away if you have new or worsening joint pain or a rash on your cheeks or arms that gets worse in the sun. Talk to your doctor about your risk of these serious side effects.

Omeprazole and Sodium Bicarbonate capsules can have other serious side effects. See “What are the possible side effects of Omeprazole and Sodium Bicarbonate capsules?” What are Omeprazole and Sodium Bicarbonate capsules? A prescription medicine called proton pump inhibitor (PPI) used to reduce the amount of acid in your stomach.

Omeprazole and Sodium Bicarbonate capsules is used in adults for: up to 8 weeks for the healing of duodenal ulcers. up to 8 weeks for the healing of stomach ulcers. up to 4 weeks to treat heartburn and other symptoms that happen with gastroesophageal reflux disease (GERD). up to 8 weeks for the healing and symptom relief of acid-related damage to the lining of the esophagus (called erosive esophagitis or EE). Your doctor may prescribe another 4 weeks of Omeprazole and Sodium Bicarbonate capsules in patients whose EE does not heal. maintaining healing of EE and to help prevent the return of heartburn symptoms caused by GERD.

It is not known if Omeprazole and Sodium Bicarbonate capsules are safe and effective when used for longer than 12 months for this purpose. It is not known if Omeprazole and Sodium Bicarbonate capsules are safe and effective in children. Do not take Omeprazole and Sodium Bicarbonate capsules if you are: allergic to omeprazole, any other PPI medicine, or any of the ingredients in Omeprazole and Sodium Bicarbonate capsules.

See the end of this Medication Guide…

Glossary — plain-language definitions of medical terms used in this label:

case series: A report describing what happened to a small group of patients, with no comparison group.

contraindicated: Should not be used in that situation, because the risk is considered too high.

exacerbation: A flare-up or worsening of a condition.

systemic lupus erythematosus: A long-term autoimmune disease in which the immune system attacks the body's own tissues, affecting joints, skin, kidneys, and other organs.

abdominal pain: Pain, cramping, or discomfort felt anywhere in the belly area.

active metabolite: A substance made when the body breaks down a medicine that still has an effect of its own.

adverse reaction: An unwanted or harmful effect that a medicine causes in the body.

Adverse Reactions: Unwanted or harmful effects that people experienced while taking a medicine, listed on its official label.

alkaline phosphatase: An enzyme measured in a blood test; higher levels can point to problems with the liver, bile ducts, or bones.

ALT: A liver enzyme (alanine aminotransferase) checked by a blood test; raised levels can signal that the liver is irritated or damaged.

anaphylaxis: A sudden, severe, whole-body allergic reaction that can cause trouble breathing, swelling, and a drop in blood pressure, needing emergency care.

angioedema: Rapid swelling deep under the skin, often around the eyes, lips, tongue, or throat.

animal reproduction studies: Tests in pregnant animals used to check whether a medicine might harm a developing baby.

anorexia: Loss of appetite, or not feeling hungry (on a drug label this means reduced appetite, not the eating disorder).

antidote: A treatment that reverses or counteracts the effects of a specific medicine or poison.

arthralgia: Joint pain.

AST: A liver enzyme (aspartate aminotransferase) measured in a blood test; higher levels may point to liver or sometimes muscle injury.

asthenia: Unusual weakness or lack of physical strength and energy.

autoimmune: Describes a condition in which the body's defense system mistakenly attacks its own healthy cells or tissues.

baseline: A person's starting condition, measured before treatment begins, used to see how much they change later on.

bilirubin: A yellow substance the liver normally clears from the blood; high levels can turn the skin or the whites of the eyes yellow.

bradycardia: A slower-than-normal heart rate, usually under 60 beats per minute.

bronchospasm: A sudden tightening of the muscles around the airways in the lungs that narrows them and makes breathing harder.

candidiasis: An infection caused by a yeast called Candida, which can affect the mouth, throat, skin, or other areas.

Clinical Pharmacology: The label section explaining how a medicine works in the body and how the body processes it.

Clinical Studies: The label section summarizing the research trials used to show that a medicine works and is acceptably safe.

constipation: Having bowel movements less often than usual, or passing stools that are hard, dry, and difficult to move.

Contraindications: A list of situations or health conditions in which a medicine should not be used because the chance of harm is too high.

CYP2C19: A liver enzyme that breaks down certain medicines, such as some stomach-acid drugs and drugs that help prevent blood clots.

delayed-release: A pill coated so it does not release its medicine until after it has passed through the stomach.

diaphoresis: Heavy or excessive sweating.

diarrhea: Loose, watery bowel movements that happen more often than normal.

Dosage and Administration: The label section explaining how much of a medicine to use and how to take or give it.

double-blind: A study in which neither the patients nor their doctors know who is getting the real medicine and who is getting the dummy.

Drug Interactions: The label section listing other medicines, foods, or substances that can change how a medicine works or raise the chance of side effects.

edema: Swelling caused by extra fluid trapped in the body's tissues.

efficacy: How well a treatment works under the controlled conditions of a clinical study.

electrolyte: A mineral in the blood and body fluids, such as sodium, potassium, or calcium, that carries a small electric charge and helps the body work.

encephalopathy: Any condition that affects how the brain works, causing confusion, memory problems, or changes in alertness.

eosinophilia: A higher-than-normal level of eosinophils, a type of white blood cell often linked to allergies or drug reactions.

esophagitis: Swelling and irritation of the lining of the food pipe, or esophagus.

estimated background risk: The normal chance that any pregnancy will have a birth defect or problem, even without taking any medicine.

flatulence: Passing gas from the bowel; feeling bloated or gassy.

flushing: Temporary redness and warmth of the skin, often on the face and neck, from widening of small blood vessels.

gastroesophageal reflux disease: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

GERD: Stomach acid flowing back up into the food pipe, causing heartburn and irritation.

Half-life: The time it takes for the amount of medicine in the blood to drop by half.

heart failure: A condition in which the heart cannot pump blood as well as it should, causing tiredness, breathlessness, and swelling.

hepatitis: Inflammation of the liver, which can be caused by infections, alcohol, or certain medicines.

hypernatremia: A higher-than-normal level of sodium (salt) in the blood.

hypersensitivity: An overreaction of the body's defense system to a substance, causing symptoms such as rash, swelling, or trouble breathing.

hypocalcemia: A lower-than-normal level of calcium, a mineral, in the blood.

hypokalemia: A lower-than-normal level of potassium, an important mineral, in the blood.

hypomagnesemia: A lower-than-normal level of magnesium, a mineral, in the blood.

immediate-release: A standard pill or capsule that releases all of its medicine soon after it is swallowed.

in utero: Inside the womb, describing a baby before it is born.

incidence: How often a new event, such as a side effect, happens in a group of people over a set period of time.

inhibitor: A substance that blocks an enzyme or transporter, which can raise the levels of drugs it normally handles.

INR: A blood test result that shows how quickly blood clots, often used to monitor blood-thinning medicines.

intravenous: Given directly into a vein through a needle or thin tube; often written as IV.

jaundice: Yellowing of the skin and the whites of the eyes caused by too much bilirubin in the blood.

lactation: The making and release of milk from a mother's breasts after giving birth.

liver function tests: Blood tests that check how well the liver is working and whether it is irritated or damaged.

malaise: A general feeling of being unwell, uneasy, or low on energy, without one clear symptom.

Mechanism of Action: How a medicine produces its effect in the body, described at the level of cells or body chemistry.

Medication Guide: An FDA-approved handout written for patients that explains important safety information about certain medicines in plain language.

Metabolism: How the body chemically changes a medicine, usually in the liver, into other substances.

metabolite: A new substance formed when the body breaks a medicine down.

NDC: A unique number that identifies a specific medicine, its maker, strength, and package size.

open-label: A study in which both the patients and their doctors know which treatment each person is receiving.

organogenesis: The early stage of pregnancy when the developing baby's organs are first forming.

osteoporosis: A condition where bones become thin and weak, making them more likely to break.

Overdosage: The label section describing what can happen if too much of a medicine is taken and how it may be treated.

pancreatitis: Painful swelling of the pancreas, an organ behind the stomach that helps digest food and control blood sugar.

peripheral edema: Swelling, usually in the feet, ankles, or legs, caused by extra fluid building up in the tissues.

placebo: An inactive treatment with no real medicine in it, such as a sugar pill, used for comparison in a study.

Prescribing Information: The official, detailed document approved by the FDA that tells health professionals how to use a prescription medicine.

prothrombin time: A blood test that measures how many seconds it takes for blood to form a clot.

QT prolongation: A longer-than-normal electrical recovery time between heartbeats, seen on a heart tracing (ECG), which can raise the chance of a dangerous heart rhythm.

receptor: A special docking spot on a cell that a medicine or natural body chemical attaches to in order to trigger an effect.

relapse: The return of a cancer after a period of improvement or disappearance.

Stevens-Johnson syndrome: A rare, serious reaction causing painful blistering and peeling of the skin and the moist linings of the mouth, eyes, and other areas.

stomatitis: Soreness, swelling, or sores on the lining inside the mouth.

suspension: A liquid holding fine drug particles that are mixed in but not fully dissolved, so it must be shaken before use.

tachycardia: A faster-than-normal heart rate, usually over 100 beats per minute.

toxic epidermal necrolysis: A rare, life-threatening reaction in which large areas of the top layer of skin blister and peel away, like a severe burn.

trimester: One of the three roughly three-month stages that a pregnancy is divided into.

urticaria: Raised, itchy welts on the skin, commonly called hives.

Warnings and Precautions: The label section describing serious risks to know about and safety steps to follow while using a medicine.

withdrawal: Uncomfortable physical or mental symptoms that appear when a medicine the body has gotten used to is reduced or stopped.

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

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🧪 All Omeprazole/Sodiium Bicarbonate NDCsSame ingredient 🏭 All Direct_rx labeler NDCsLabeler code 72189 📚 All Proton Pump Inhibitor NDCsDrug class

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Omeprazole 00113-0520-55

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Omeprazole/Sodiium Bicarbonate 40 mg; 1100 mg Capsule, 30-count — NDC 72189-568-30 (Billing 72189-0568-30)

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