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Prilosec OTC
Omeprazole Magnesium · Tablet, Delayed Release
Overview
Active ingredients
Source: NDC DirectoryForms, strengths and routes
Source: NDC DirectoryPharmacologic classes are listed in the class section below.
Pharmacologic class
Source: NDC Directory| Class | Type | Browse |
|---|---|---|
| Cytochrome P450 2C19 Inhibitors [MoA] | MoA | All 93 members |
| Proton Pump Inhibitor [EPC] | EPC | All 74 members |
| Proton Pump Inhibitors [MoA] | MoA | All 74 members |
Regulatory status
Source: Drugs@FDANDC Directory| Product | Trade name | Form | Strength | Ingredient | Status | TE | Flags |
|---|---|---|---|---|---|---|---|
| 206582-001 | OMEPRAZOLE MAGNESIUM | TABLET, DELAYED RELEASE | OMEPRAZOLE MAGNESIUM | Over-the-counter | — |
Approval history
Source: Drugs@FDA| Type | No. | Action | Status | Date | Review |
|---|---|---|---|---|---|
| Supplement | 2 | Labeling | Approved | October 21, 2024 | Standard |
| Original application | 1 | Approved | June 1, 2020 | Standard |
Review documents
- 0 · Original application · December 18, 2017
Prescribing information
Source: openFDA Drug LabelingReproduced verbatim from the Structured Product Labeling submitted to the FDA (effective 20260729). This is the manufacturer's labelling text, not a summary and not advice.
Indications and Usage
openFDA Drug LabelingUse 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 LabelingPurpose Acid reducer
Dosage and Administration
openFDA Drug LabelingDirections 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; some people get complete relief of symptoms within 24 hours 14-Day Course of Treatment swallow 1 tablet with a glass of water before eating in the morning take every day for 14 days do not take more than 1 tablet a day do not use for more than 14 days unless directed by your doctor swallow whole. Do not chew, crush, or suck tablets. 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 LabelingWarnings 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
openFDA Drug LabelingDo 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 LabelingAsk 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
Stop Use
openFDA Drug LabelingStop 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 LabelingActive ingredient (in each tablet) Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Overdosage
openFDA Drug LabelingIn case of overdose, get medical help or contact a Poison Control Center right away.
Adverse event reports
Source: openFDA FAERSAttributed to this product's most-reported active ingredient: OMEPRAZOLE MAGNESIUM. 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| Package NDC | Product NDC | Labeler | Description | Marketing start |
|---|---|---|---|---|
| 37000-455-01 | 37000-455 | The Procter & Gamble Manufacturing Company | 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-455-01) | July 14, 2003 |
| 37000-455-02 | 37000-455 | The Procter & Gamble Manufacturing Company | 1 BLISTER PACK in 1 CARTON (37000-455-02) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | July 14, 2003 |
| 37000-455-03 | 37000-455 | The Procter & Gamble Manufacturing Company | 2 CARTON in 1 CARTON (37000-455-03) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | July 14, 2003 |
| 37000-455-04 | 37000-455 | The Procter & Gamble Manufacturing Company | 3 CARTON in 1 CARTON (37000-455-04) / 1 BLISTER PACK in 1 CARTON / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | July 14, 2003 |
| 37000-455-05 | 37000-455 | The Procter & Gamble Manufacturing Company | 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-455-05) | July 14, 2003 |
| 37000-459-01 | 37000-459 | The Procter & Gamble Manufacturing Company | 1 TABLET, DELAYED RELEASE in 1 POUCH (37000-459-01) | August 15, 2012 |
| 37000-459-02 | 37000-459 | The Procter & Gamble Manufacturing Company | 14 BLISTER PACK in 1 CARTON (37000-459-02) / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | August 15, 2012 |
| 37000-459-04 | 37000-459 | The Procter & Gamble Manufacturing Company | 3 CARTON in 1 CARTON (37000-459-04) / 14 BLISTER PACK in 1 CARTON / 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK | August 15, 2012 |
| 37000-459-05 | 37000-459 | The Procter & Gamble Manufacturing Company | 1 TABLET, DELAYED RELEASE in 1 BLISTER PACK (37000-459-05) | August 15, 2012 |
| 84126-300-14 | 84126-300 | The Procter & Gamble Manufacturing Company | 1 BLISTER PACK in 1 CARTON (84126-300-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | September 1, 2025 |
| 84126-300-24 | 84126-300 | The Procter & Gamble Manufacturing Company | 2 BLISTER PACK in 1 CARTON (84126-300-24) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | September 1, 2025 |
| 84126-300-42 | 84126-300 | The Procter & Gamble Manufacturing Company | 3 BLISTER PACK in 1 CARTON (84126-300-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | September 1, 2025 |
| 84126-300-56 | 84126-300 | The Procter & Gamble Manufacturing Company | 4 BLISTER PACK in 1 CARTON (84126-300-56) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | July 29, 2026 |
| 84126-301-14 | 84126-301 | The Procter & Gamble Manufacturing Company | 1 BLISTER PACK in 1 CARTON (84126-301-14) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | June 3, 2025 |
| 84126-301-42 | 84126-301 | The Procter & Gamble Manufacturing Company | 3 BLISTER PACK in 1 CARTON (84126-301-42) / 14 TABLET, DELAYED RELEASE in 1 BLISTER PACK | June 3, 2025 |
| 37000-455 | 37000-455 | The Procter & Gamble Manufacturing Company | — | July 14, 2003 |
| 37000-459 | 37000-459 | The Procter & Gamble Manufacturing Company | — | August 15, 2012 |
| 84126-300 | 84126-300 | The Procter & Gamble Manufacturing Company | — | September 1, 2025 |
| 84126-301 | 84126-301 | The Procter & Gamble Manufacturing Company | — | June 3, 2025 |
Sources for 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 · 10 sections on this page.