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Omeprazole and sodium bicarbonate

Omeprazole, sodium bicarbonate · Capsule, Gelatin Coated

Over-the-counter ANDA Official labelling
Informational index, not medical advice. Content is reproduced from public FDA and NLM data. Always confirm against the manufacturer's current prescribing information. Report adverse events to FDA MedWatch.

Overview

Brand name
Omeprazole and sodium bicarbonate
Generic name
Omeprazole, sodium bicarbonate
Dosage form
Capsule, Gelatin Coated
Route
Oral
Marketing category
ANDA · ANDA
Labeler
Walgreen Company
Product type
Human Otc Drug
DEA schedule
Not scheduled
Active ingredients
2
NDC product codes
5
Packages
7
Data completeness
82% of corroborating sources present

Active ingredients

Source: NDC Directory
Active ingredients and strengths as listed in the NDC Directory.
Ingredient Strength RxCUI Monograph
Omeprazole 20 mg/1 200329 View
Sodium Bicarbonate 1100 mg/1 1868486 View

Forms, strengths and routes

Source: NDC Directory
Dosage form
Capsule, Gelatin Coated
Route of administration
Oral
Presentations
12

Pharmacologic classes are listed in the class section below.

Pharmacologic class

Source: NDC Directory
Established pharmacologic classes (EPC), mechanisms of action (MoA), chemical structures (CS) and physiologic effects (PE).
Class Type Browse
Cytochrome P450 2C19 Inhibitors [MoA] MoA All 93 members
Increased Large Intestinal Motility [PE] PE All 83 members
Inhibition Large Intestine Fluid/Electrolyte Absorption [PE] PE All 83 members
Osmotic Activity [MoA] MoA All 105 members
Osmotic Laxative [EPC] EPC All 103 members
Proton Pump Inhibitor [EPC] EPC All 74 members
Proton Pump Inhibitors [MoA] MoA All 74 members

Regulatory status

Source: Drugs@FDANDC Directory
Application number
201361
Application type
ANDA · Abbreviated New Drug Application
Approval date
July 15, 2016
Sponsor
PERRIGO R AND D
Products on application
1
Submissions recorded
5
Products approved under application 201361.
Product Trade name Form Strength Ingredient Status TE Flags
201361-001 OMEPRAZOLE AND SODIUM BICARBONATE CAPSULE OMEPRAZOLE; SODIUM BICARBONATE Over-the-counter —

Approval history

Source: Drugs@FDA
Most recent submissions on application 201361.
Type No. Action Status Date Review
Supplement 17 Labeling Approved February 5, 2024 Standard
Supplement 15 Labeling Approved February 5, 2024 Standard
Supplement 6 Labeling Approved February 5, 2024 Standard
Supplement 4 Labeling Approved February 5, 2024 Standard
Original application 1 Not Applicable Approved July 15, 2016 —

Review documents

  • 0 · Original application · July 21, 2016
  • 0 · Original application · July 20, 2016

Prescribing information

Source: openFDA Drug Labeling

Reproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20251103). This is the manufacturer's labelling text, not a summary and not advice.

HUMAN OTC DRUG · 20251103

Indications and Usage

openFDA Drug Labeling

Use • treats frequent heartburn (occurs 2 or more days a week) • not intended for immediate relief of heartburn. This drug may take 1 to 4 days for full effect.

Purpose

openFDA Drug Labeling

Purpose Acid reducer Allows absorption of this omeprazole product

Dosage and Administration

openFDA Drug Labeling

Directions • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning • take every day for 14 days • do not take more than 1 capsule a day • do not chew or crush the capsule • do not open capsule and sprinkle on food • do not use for more than 14 days unless directed by your doctor Repeated 14-Day Courses (if needed) • you may repeat a 14-day course every 4 months • do not take for more than 14 days or more often than every 4 months unless directed by a doctor • children under 18 years of age: ask a doctor. Heartburn in children may sometimes be caused by a serious condition.

Warnings

openFDA Drug Labeling

Warnings 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: • 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 • had heartburn over 3 months. This may be a sign of a more serious condition. • frequent wheezing, particularly with heartburn • unexplained weight loss • nausea or vomiting • stomach pain • a sodium-restricted diet Ask a doctor or pharmacist before use if you are taking a prescription drug. Acid reducers may interact with certain prescription drugs. Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain If pregnant or breast-feeding, ask a health professional before use. 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).

Do Not Use

openFDA Drug Labeling

Do not use if you have: • 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

openFDA Drug Labeling

Ask a doctor before use if you have • 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

Stop Use

openFDA Drug Labeling

Stop use and ask a doctor if • your heartburn continues or worsens • you need to take this product for more than 14 days • you need to take more than 1 course of treatment every 4 months • you get diarrhea • you develop a rash or joint pain

Active Ingredient

openFDA Drug Labeling

Active ingredients (in each capsule) Omeprazole 20 mg Sodium Bicarbonate 1100 mg

Adverse event reports

Source: openFDA FAERS
448,269
FAERS reports mentioning this drug
as of 2026-09-25T03:42:24+00:00
A report count is not a risk measure. FAERS accepts voluntary and mandatory reports without establishing causation, and reporting is influenced by how widely a drug is used, how long it has been marketed, and media attention. FDA states that reports “do not prove that the drug caused the event”. Compare rates, not totals.

Attributed to this product's most-reported active ingredient: OMEPRAZOLE. Combination products with more than six active ingredients are not attributed, because a report count summed across a long ingredient list measures the list, not the medicine.

Packaging and NDCs

Source: NDC Directory
Every National Drug Code package associated with this medication. The NDC is the identifier used for dispensing, billing and pharmacovigilance in the United States.
Package NDC Product NDC Labeler Description Marketing start
72288-564-03 72288-564 Amazon.com Services LLC 3 BOTTLE in 1 CARTON (72288-564-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE (72288-564-00) August 19, 2026
59779-732-01 59779-732 CVS Pharmacy 1 BOTTLE in 1 CARTON (59779-732-01) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE July 15, 2016
59779-732-03 59779-732 CVS Pharmacy 3 BOTTLE in 1 CARTON (59779-732-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE July 15, 2016
37808-732-01 37808-732 H E B 1 BOTTLE in 1 CARTON (37808-732-01) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE August 25, 2017
37808-732-03 37808-732 H E B 3 BOTTLE in 1 CARTON (37808-732-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE August 25, 2017
41250-938-03 41250-938 Meijer Distribution Inc 3 BOTTLE in 1 CARTON (41250-938-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE (41250-938-01) April 3, 2020
0363-0732-03 0363-0732 Walgreen Company 3 BOTTLE in 1 CARTON (0363-0732-03) / 14 CAPSULE, GELATIN COATED in 1 BOTTLE (0363-0732-01) July 15, 2016
72288-564 72288-564 Amazon.com Services LLC — August 19, 2026
59779-732 59779-732 CVS Pharmacy — July 15, 2016
37808-732 37808-732 H E B — August 25, 2017
41250-938 41250-938 Meijer Distribution Inc — April 3, 2020
0363-0732 0363-0732 Walgreen Company — July 15, 2016

Sources for this page

Every dataset that contributed a fact to this page.
Dataset Agency Used for
NDC Directory FDA Identity, ingredients, strengths, forms, routes, labelers, packages
Drugs@FDA FDA Application, sponsor, submissions, review documents, marketing status
Drug Labeling FDA / NLM Prescribing information reproduced above
FAERS FDA Adverse event report counts

Generated September 25, 2026 · 11 sections on this page.