Omeprazole
Proton pump inhibitor
- Prilosec OTC
- Frequent heartburn, as a 14-day course
- Omeprazole delayed-release capsules
- GERD, erosive oesophagitis, ulcers
Prilosec OTC
Omeprazole delayed-release capsules
Each stripe is one section of the label, each division in a stripe one entry in that section.
Reference information, not medical advice
This page is a reference, not medical advice. It reports what the FDA-approved label states and links to that label. It does not tell anyone what to take, and it cannot replace a conversation with a doctor or pharmacist who knows the person's history.
Omeprazole is sold both over the counter as Prilosec OTC and on prescription as a generic capsule. The two are described by different documents: the shop version is approved for a 14-day course against frequent heartburn, the prescription one for duodenal and gastric ulcers, GERD and erosive oesophagitis.
Brands and what each one is approved for
One active ingredient can hold several separate FDA approvals. They are different documents with different approved uses, and mixing them up is the most common mistake made about these medications.
| Brand | What its label approves | Supply | Label version |
|---|---|---|---|
| Prilosec OTCThe Procter & Gamble Manufacturing Company | Frequent heartburn, as a 14-day courseCovers heartburn | Over the counter | 1 October 2025 |
| Omeprazole delayed-release capsulesCamber Pharmaceuticals, Inc. | GERD, erosive oesophagitis, ulcersCovers heartburn | Prescription | 9 January 2025 |
How it works
Neither document treats omeprazole as something to take when heartburn starts. The over-the-counter label is the one that says so outright, stating that the product is not intended for immediate relief and may take 1 to 4 days for full effect; that is why it is written as a 14-day course rather than as a dose to keep for bad evenings. The prescription label makes the same point differently, by setting a duration for each condition rather than a moment to take it.
Mechanism of action, Omeprazole delayed-release capsules label
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 acid-pump 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.
What this product is for
The approved uses, as worded in the label.
Prilosec OTC
- Acid reducer
- 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
Omeprazole delayed-release capsules
- Treatment of active duodenal ulcer in adults
- Eradication of Helicobacter pylori to reduce the risk of duodenal ulcer recurrence in adults
- Treatment of active benign gastric ulcer in adults
- Treatment of symptomatic gastroesophageal reflux disease (GERD) in patients 2 years of age and older
- Treatment of erosive esophagitis (EE) due to acid-mediated GERD in patients 2 years of age and older
- Pathologic hypersecretory conditions in adults Treatment of Active Duodenal Ulcer Omeprazole delayed-release capsules are indicated for short-term treatment of active duodenal ulcer in adults. Most patients heal within four weeks. Some patients may require an additional four weeks of therapy. Helicobacter pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Eradication of H.
Active ingredient (in each tablet)
The presentations and strengths listed in the label.
Prilosec OTC
Omeprazole delayed-release tablet 20 mg (equivalent to 20.6 mg omeprazole magnesium)
Omeprazole delayed-release capsules
Omeprazole Delayed-Release Capsules: 10 mg and 20 mg
Directions
What the label states about administration. It is not a dosing instruction for any individual.
Prilosec OTC
- 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.
- 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.
Omeprazole delayed-release capsules
2 DOSAGE & ADMINISTRATION Indication Recommended Adult and Pediatric Dosage Treatment of Active Duodenal Ulcer 20 mg once daily for 4 weeks; some patientsmay require an additional 4 weeks H. pylori Eradication to Reduce the Risk of Duodenal Ulcer Recurrence Triple Therapy: Omeprazole delayed-release capsules amoxicillin clarithromycin 20mg 1000mg 500mg Each drug twice daily for 10 days * Dual...
Stop use and ask a doctor if:
The adverse reactions the label reports as most common.
Prilosec OTC
• 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
Omeprazole delayed-release capsules
- Most common adverse reactions in adults (incidence ≥ 2%) are • Headache, abdominal pain, nausea, diarrhea, vomiting, and flatulence.
- most common adverse reactions reported (i.e., with an incidence rate ≥ 2%) from omeprazole-treated patients enrolled in these studies included headache (7%), abdominal pain (5%), nausea (4%), diarrhea (4%), vomiting (3%), and flatulence (3%).
Warnings
The warnings and precautions section of the label.
Prilosec OTC
- 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
Omeprazole delayed-release capsules
- Gastric Malignancy: In adults, symptomatic response does not preclude the presence of gastric malignancy. Consider additional follow-up and diagnostic testing.
- Acute Interstitial Nephritis: Observed in patients taking PPIs.
- Clostridium difficile -Associated Diarrhea: PPI therapy may be associated with increased risk.
- Bone Fracture: Long-term and multiple daily dose PPI therapy may be associated with an increased risk for osteoporosis-related fractures of the hip, wrist or spine.
- Cutaneous and Systemic Lupus Erythematosus: Mostly cutaneous; new onset or exacerbation of existing disease; discontinue omeprazole and refer to specialist for evaluation
- Interaction with Clopidogrel: Avoid concomitant use of omeprazole.
- Cyanocobalamin (Vitamin B-12) Deficiency: Daily long-term use (e.g., longer than 3 years) may lead to malabsorption or a deficiency of cyanocobalamin.
- Hypomagnesemia: Reported rarely with prolonged treatment with PPIs.
Do not use if
Situations in which the label states the medication must not be used.
Prilosec OTC
- trouble or pain swallowing food, vomiting with blood, or bloody or black stools
- heartburn with lightheadedness, sweating or dizziness
- chest pain or shoulderpain with shortness of breath; sweating; pain spreading to arms, neck, or shoulders; or lightheadedness
- frequent chest pain
Omeprazole delayed-release capsules
- Patients with known hypersensitivity to substituted benzimidazoles or any component of the formulation.
- Patients receiving rilpivirine-containing products.
- Refer to the Contraindications section of the prescribing information for clarithromycin and amoxicillin, when administered in combination with omeprazole delayed-release capsules.
Drug interactions
Interactions the label singles out.
Omeprazole delayed-release capsules
There are other antiretroviral drugs which do not result in clinically relevant interactions with omeprazole. Intervention: Rilpivirine-containing products: Concomitant use with omeprazole is contraindicated. Atazanavir: Avoid concomitant use with omeprazole. See prescribing information for atazanavir for dosing information. Nelfinavir: Avoid concomitant use with omeprazole.
Pregnancy and breastfeeding
The opening of the pregnancy section of the label. The full section is longer and is in the source document.
Prilosec OTC
ask a health professional before use.
Omeprazole delayed-release capsules
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.
Generic or brand
Generic omeprazole is approved and widely available in both prescription and over-the-counter form.
The FDA label database lists 31 approved generic applications for this ingredient.
What affects the cost
Omeprazole is an old generic sold in supermarkets as well as pharmacies, and prices differ accordingly. This site sells nothing and links to no sellers.
What pharmacies pay for it
These are acquisition costs: what pharmacies in the United States pay on average to buy the medication, published weekly by the Centers for Medicare and Medicaid Services. They are not retail prices and not what a person pays at the counter, which depends on insurance, pharmacy and discount programmes. They are useful as an objective floor and for seeing how far a brand sits above its generic.
| Measured | Brand | Generic |
|---|---|---|
| per tablet, capsule or pen | $14.78 (range $14.72 to $14.82, 60 listings) | $0.051 (range $0.028 to $0.450, 3926 listings) |
Median of 3986 listings. Effective dates 2025-12-17 to 2026-07-22, file dated 2026-07-29.
Compared with other medications
What the labels do not do is compare one medication against another. These pages put two of them side by side.
Common questions
- Is over-the-counter omeprazole the same strength as prescription omeprazole?
- Prilosec OTC is a 20 mg delayed-release tablet, and the prescription capsules come in 10 mg and 20 mg. So the same 20 mg exists in both, under two labels with different approved uses, different durations and different age limits.
- How long can it be taken?
- The over-the-counter label sets a 14-day course, once daily, and states not to use it for more than 14 days unless a doctor directs it. The prescription label sets a duration for each approved indication instead, from four weeks for an active duodenal ulcer upward.
- Does it work straight away?
- The label says it may take 1 to 4 days for full effect, and that some people get complete relief within 24 hours. It also states that the product is not intended for immediate relief of heartburn.
Other medications under heartburn
Whether each one carries an FDA approval for this use is marked on its page and in this list.
Sources
Every fact above comes from one of these documents. The date is the effective date of the label version this page was built from.
FDA prescribing information for Prilosec OTC
The Procter & Gamble Manufacturing Company. Label version 17, effective 1 October 2025.
FDA prescribing information for Omeprazole delayed-release capsules
Camber Pharmaceuticals, Inc.. Label version 2, effective 9 January 2025.
Page last updated: 11 August 2026
Compiled by the HealthyStudy editorial team from FDA source documents. No medical reviewer is credited on this page, because none reviewed it.