Drugplain

OMEPRAZOLE AND SODIUM BICARBONATE 20 mg/1

OMEPRAZOLE AND SODIUM BICARBONATE · CAPSULE · Aurohealth LLC

1 Recall on RecordCurrently in Shortage
Plain English

Omeprazole and sodium bicarbonate is an over-the-counter capsule that reduces stomach acid to relieve heartburn and acid reflux symptoms. This medication belongs to a class of drugs called proton pump inhibitors, which work by decreasing the amount of acid your stomach produces.

Key Facts

Brand Name
OMEPRAZOLE AND SODIUM BICARBONATE
Generic Name
OMEPRAZOLE AND SODIUM BICARBONATE
NDC Code (Product)
58602-725
Manufacturer
Aurohealth LLC
Strength
20 mg/1
Dosage Form
CAPSULE
Route
ORAL
Marketing Status
Application #
ANDA204923
Drug Class
Proton Pump Inhibitor [EPC]
Marketing Start
12/22/2023

Recall History

1 Recall on Record
Class II02/02/2024

Bausch Health Companies, Inc.

Subpotent Drug: Out of specification for assay

CompletedVoluntary: Firm initiated

Side Effects Reported to FDA

FDA FAERS database · These are reported events, not confirmed side effects

chronic kidney disease118 reports
drug ineffective66 reports
acute kidney injury53 reports
renal failure53 reports
incorrect product administration duration39 reports
nausea33 reports
headache27 reports
inappropriate schedule of product administration27 reports
death22 reports
dyspnoea22 reports

Full Prescribing Information

Source: FDA Drug Label (SPL)For healthcare professionals

Indications & Usage

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.

Dosage & Administration

Directions • for adults 18 years of age and older • this product is to be used once a day (every 24 hours), every day for 14 days • it may take 1 to 4 days for full effect, although some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment • swallow 1 capsule with a glass of water at least 1 hour before eating in the morning • take every day for 14 days • do not take more than 1 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

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 •…

Frequently Asked Questions

What is OMEPRAZOLE AND SODIUM BICARBONATE used for?

Omeprazole and sodium bicarbonate is an over-the-counter capsule that reduces stomach acid to relieve heartburn and acid reflux symptoms. This medication belongs to a class of drugs called proton pump inhibitors, which work by decreasing the amount of acid your stomach produces.

Is OMEPRAZOLE AND SODIUM BICARBONATE a controlled substance?

OMEPRAZOLE AND SODIUM BICARBONATE is not classified as a controlled substance by the DEA.

What is the generic name for OMEPRAZOLE AND SODIUM BICARBONATE?

The generic name for OMEPRAZOLE AND SODIUM BICARBONATE is OMEPRAZOLE AND SODIUM BICARBONATE. There are 11 other brand versions of OMEPRAZOLE AND SODIUM BICARBONATE.

What is the NDC code for OMEPRAZOLE AND SODIUM BICARBONATE 20 mg/1?

The NDC (National Drug Code) for OMEPRAZOLE AND SODIUM BICARBONATE 20 mg/1 is 58602-725, listed by Aurohealth LLC.

Product NDC

58602-725

Package NDC

58602-725-05

Other Omeprazole Brands

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Not medical advice. Always consult your doctor or pharmacist before making any medication decisions.

Data from openFDA · Public domain (CC0 1.0)