What this pack is
Prilosec OTC is the brand name in this record; omeprazole is the generic name. Read both together with the dosage form (oral tablet).
PACK CHECK · MARKET FIRST
Prilosec OTCGeneric nameomeprazole
Mainland China pack-name cue洛赛克®Historical or public source cue · verify the current target-market record
How this medicine works
FDA public PRILOSEC pharmacology material describes omeprazole as suppressing gastric acid secretion through specific inhibition of the H⁺/K⁺ ATPase enzyme system at the secretory surface of the gastric parietal cell, often called the gastric “proton pump.” It explains a drug-action pathway, not an answer for an individual's symptoms, course, capsule count or combination plan.
Read source: United States ↗Historical public record · reviewed 2026-08-20More about its action and precautions →Check the market, names, dosage form and route together
A medicine may use different brand names across markets. Keep the market, brand, generic name, dosage form and route together; one matching field does not prove that two packs are the same or interchangeable.
Open the complete product-identity record
Use these fields when the pack, market name or package image needs closer checking. They are evidence boundaries, not substitution instructions.
- Mainland China pack-name cue
- 洛赛克®
- International brand name
- Prilosec OTC
- Generic name
- omeprazole
- Dosage-form class
- Omeprazole magnesium delayed-release tablets (OTC): this dossier precisely displays the 20 mg 42-tablet carton; PRILOSEC prescription delayed-release capsules are not included
- Route
- Oral
- Package-image status
- A source-linked public label image is available below
Mainland China trade-name search cue:洛赛克®. This is a historical/public cue for reading pack text. It does not establish current approval, holder, supply or sale eligibility.
FOR EVERYDAY QUESTIONS
After the leaflet, continue with the question you still need to check
What this page can show
This is a source-traceable public record. It helps you read the product identity and its listed source documents; each market still needs its own current record check.
What to bring to the next conversation
Bring the actual pack, the label or prescription, and a complete medicine list when you speak with a pharmacist or clinician.
NEXT SAFE STEP
Choose the next safe check
A question about changing, combining or splitting?Put the exact packs on one list before a pharmacist or prescriber checks the full context.Open the family medicine list →A question about cost, reimbursement or availability?First lock the market, exact presentation and date. Use local official reimbursement, hospital or pharmacy channels for a current answer rather than a web estimate.Open regulator and market-record entry points →Unsure about a pack or a cross-border product?Photo reading can return possible record matches only. Check the actual product against the current regulator record for its market.Identify pack text locally →Saw a recall, approval or procurement headline?Open the original publisher, then match its product, market and date. Do not make a stop or switch decision from a headline.Read primary-source news →
PRODUCT PRESENTATION IDENTITY
Strength, pack and device identity
Package strength is not an individual dose. These fields help identify the exact labelled product; they do not calculate how much, how often, a missed-use action, splitting, switching or conversion.
1 source-backed strength, pack or device records — open the full list
First match the market, dosage form and labelled amount on the pack in hand. The number of tablets, sachets or devices in a pack is not a personal dose or schedule.
United States label · DailyMed SPL v2 (effective 10 Jun 2025; published 12 Jun 2025)
20 mg per tablet; 42-tablet carton (3 blisters × 14 tablets)
- Product code
- NDC 84126-301-42
- Form and route
- omeprazole magnesium delayed-release tablet (OTC) · oral (label product-identity field only)
- Container
- carton
- Units in each inner container
- 14 tablets per blisterPackage identity only; not an individual amount to take
- Listing review
- Current label display and NDC Directory listing reviewed 2026-08-21; actual marketing, stock and availability are not established.
- omeprazole delayed-release tablet
- 20 mglabelled amount per tablet; not an individual tablet count, course or conversion instruction
- Package
- 42 tablets per carton
PUBLIC LABEL IMAGE
Appearance and package-text clues
This current public-label package panel helps check the brand, generic name, strength and dosage-form clues only. It does not authenticate a product in hand or establish originator status, availability, sale eligibility, another package or another market.
Open the public label source ↗LABEL READING · NOT A PRESCRIPTION
PRILOSEC OTC label reading: this delayed-release tablet is not the same product as a same-name prescription capsule
Reading level: drug-specific label reading. This record has been expanded around its dosage form or a higher-risk reading question; the current target-market label and professional review still apply.
This module first uses the U.S. 2025 DailyMed PRILOSEC OTC delayed-release tablet as the exact pack-reading entry point, then uses a 2010 FDA historical record to explain why same-name prescription capsules and delayed-release oral suspension cannot be merged. It does not turn label treatment tables into an individual prescription or self-use instruction.
- This page precisely displays PRILOSEC OTC delayed-release tablets, 20 mg, in a 42-tablet carton (3 blisters × 14 tablets). It does not represent PRILOSEC prescription delayed-release capsules, delayed-release oral suspension or another omeprazole product; a shared name, 20 mg strength or similar package number does not make products self-interchangeable.
- “Delayed release/enteric” describes how a formulation is designed to release and pass through the stomach environment; it does not mean “stronger” or that one unit can generally be split for two uses. Opening, sprinkling, splitting, crushing or changing form can only be confirmed from the current label for that exact product and a pharmacist.
- The label also lists several co-medications that may be affected through gastric acidity or metabolic pathways. When antiplatelet, anticoagulant, antiseizure, antiviral, immunosuppressant or other prescription medicines are used, bring the complete list to a pharmacist; do not self-stop, replace or add a medicine because an online page mentions a “stomach-medicine interaction.”
- The exact pack on this page comes from a U.S. 2025 OTC label, while the FDA document used to distinguish prescription capsules and suspension is a 2010 historical record. Neither establishes current strengths, packaging, indications or availability in China or another market. Swallowing difficulty, vomiting blood, black stools or chest pain are not situations for self-assessment from a webpage.
PHARMACOVIGILANCE · OFFICIAL ROUTES
Check safety information in the right market
Start with the public label or product record linked to this dossier, then use the official safety routes below for the market that applies to the medicine in hand.
Match five details before using a safety record
- Brand and generic nameBoth must match the medicine named by the record.
- Dosage form and strengthTablet, capsule, injection, inhaler, patch and eye drop are not interchangeable.
- Market and notice dateA record applies only to the country or region and date it names.
- Lot, pack and manufacturerRecord these only when the official notice specifically names them.
- Current product informationA historical record may have been superseded by the current label.
This checklist only helps organise the right question. It does not create a personal conclusion about stopping, switching, dose, combination or suitability.
This dossier’s product-level source checkFDA · United States · Regulatory product record or label archive · 2026-08-20
This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk.
Markets actually represented by the reviewed product documents
- United States · 2
This is a document-coverage summary, not a claim that the medicine is authorised, supplied, interchangeable or actively monitored in every listed market today.
This record’s label or product-record routeFDA: PRILOSEC 2010-08 prescribing information ↗Historical public record · reviewed 2026-08-20
Other official market or version documents for this record
These are separately reviewed product documents for the same dossier. Their market, date, dosage form and document status must stay attached to each link; they do not establish interchangeability between products, strengths, packs, indications or countries.
- U.S. National Library of Medicine DailyMed · United States · Public medicine label · 2026-08-20DailyMed (NLM): PRILOSEC OTC omeprazole magnesium delayed-release-tablet public label (P&G; SPL v2) ↗reviewed 2026-08-20
Reviewed official safety records
A dated record is not automatically a current alert. Read the named product, form, batch, market, date and source type before treating it as relevant.
- FDA Drug Safety Communication: C. difficile-associated diarrhoea communication for PPIs including Prilosec OTC2012-02-08 · On 2012-02-08, FDA issued a class Drug Safety Communication saying that proton-pump inhibitors (PPIs), a group of stomach-acid medicines, may be associated with increased risk of Clostridioides difficile-associated diarrhoea (CDAD). FDA’s current OTC heartburn page lists Prilosec OTC (omeprazole magnesium) as a PPI and links this communication. This is a dated U.S. class communication: it cannot diagnose a cause of diarrhoea, determine individual risk for PRILOSEC OTC 20 mg delayed-release tablets, prescription omeprazole, another PPI or another market, or support self-stopping, dose changes, extending a course or switching acid-reducing medicines. Diarrhoea that does not improve or another acute concern needs prompt local medical support and review of the actual pack, complete medicine list and current label with a pharmacist or prescribing team.Primary-source record (open linked document) ↗reviewed 2026-08-22
Global official safety gateways
- NMPA Centre for Drug Reevaluation · Mainland ChinaPrimary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item.Drug-vigilance bulletins and safety notices ↗reviewed 2026-08-22
- FDA · United StatesPrimary FDA pages for important new safety issues, labelling changes and risk communications.Drug Safety Communications ↗reviewed 2026-08-22
- FDA MedWatch · United StatesU.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality.Safety information and serious-problem reporting ↗reviewed 2026-08-22
- EMA · European Union / European Economic AreaOfficial EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment.Pharmacovigilance overview and EudraVigilance ↗reviewed 2026-08-22
- MHRA · United KingdomPrimary UK MHRA medicine-safety updates for professionals and the public.Drug Safety Update ↗reviewed 2026-08-22
- PMDA · JapanPMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents.Medicine safety information ↗reviewed 2026-08-22
- MFDS · Republic of KoreaMFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case.Medicine safety letters ↗reviewed 2026-08-22
- HSA · SingaporeHSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information.Adverse-event reporting and medicine-safety information ↗reviewed 2026-08-22
- Health Canada · CanadaHealth Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item.MedEffect Canada: advisories, warnings and recalls ↗reviewed 2026-08-22
- TGA · AustraliaPrimary Australian TGA safety alerts, advisories and monitoring information for therapeutic products.Medicine safety alerts ↗reviewed 2026-08-22
- Swissmedic · SwitzerlandOfficial Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality.Pharmacovigilance and suspected adverse-reaction reporting ↗reviewed 2026-08-22
- Medsafe · New ZealandNew Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information.Medicine safety communications ↗reviewed 2026-08-22
- SAHPRA · South AfricaSAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information.Medicine safety information, alerts and pharmacovigilance ↗reviewed 2026-08-22
- WHO · GlobalWHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market.Medicine and vaccine safety-alert archive ↗reviewed 2026-08-22
- Anvisa · BrazilAnvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item.Pharmacovigilance, alerts and VigiMed ↗reviewed 2026-08-22
This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline.
For severe or rapidly worsening symptoms, suspected overdose, a severe allergic reaction, loss of consciousness or another emergency, use local emergency services. Do not wait for an online alert search or change a medicine from this page.
PRIVATE FAMILY LIST
Bring this record into a local medicine list
Only the brand, generic name, dosage form and route are added, and they stay in this browser. Copy strength, label directions, start/stop history and any concern from the actual pack; this tool does not calculate a dose or decide combination, switching or stopping.
Add to the family medicine list →PACK · LABEL · MEDICINE LIST
Six checks for this medicine pack
Use this card to organise questions about Prilosec OTC (omeprazole). Keep the exact pack, its current label and the full medicine list together.
Identify the exact product
Prilosec OTC is the brand in this record and omeprazole is the active-ingredient name. Check both with the dosage form (Omeprazole magnesium delayed-release tablets (OTC): this dossier precisely displays the 20 mg 42-tablet carton; PRILOSEC prescription delayed-release capsules are not included) and the market on the actual pack.
Read the labelled strength in context
mg, mcg, mg/mL or a percentage describes the labelled amount in one tablet, capsule, measured volume, spray or other unit. It is not an answer to how many units a person should take.
Check before splitting or opening
Before splitting, crushing, chewing or opening anything, find an explicit instruction for this exact product in its current label and ask a pharmacist. A score line or a previous pack is not enough by itself.
Put every product on one list
Include prescriptions, over-the-counter products, eye drops, creams, vitamins, minerals, herbs and supplements. A pharmacist or prescriber needs the whole list before any combination, alternation, switch or stop is considered.
Ask a specific pharmacogenetics question
Ask which medicine, which gene and what clinical decision a result could change. A gene–drug association does not mean broad genetic testing is needed for everyone and must not be used to change treatment without professional review.
Know when to seek urgent help
For a suspected overdose, a severe allergic reaction, fainting or difficulty breathing, use the local emergency or poison-information service now. Do not wait for a website reply or alter several medicines to test what caused it.
This card does not calculate a dose, decide whether medicines can be combined, or replace a clinician or pharmacist. Market-specific current labels and the person's full context still need review.
MARKET DOCUMENTS · READ SEPARATELY
Enlarged market leaflets and regulator documents
Each link retains its own market, date, dosage form and document status. These documents support larger-print reading and item-by-item checking; they do not make products, strengths, packs, indications or use between countries or regions interchangeable.
- FDA: PRILOSEC 2010-08 prescribing information ↗Historical public record · reviewed 2026-08-20
- DailyMed (NLM): PRILOSEC OTC omeprazole magnesium delayed-release-tablet public label (P&G; SPL v2) ↗reviewed 2026-08-20
HOW IT WORKS · NOT A TREATMENT PLAN
How omeprazole works: it acts on the gastric parietal-cell “proton pump”
- Read the “proton pump” as one final step in gastric-acid production. It explains why omeprazole is an acid-suppression medicine, but it cannot infer the cause of a person's stomach pain, reflux, cough or chest discomfort, or replace diagnosis and the current target-market label.
- Delayed-release capsules and delayed-release oral suspension can both contain omeprazole while having different forms, units and handling requirements. A shared mechanism does not make them the same capsule count or millilitre amount, or products that can be freely opened, split, crushed or exchanged.
- The PRILOSEC label lists medicines requiring co-medication review, and the current U.S. PLAVIX label specifically warns that omeprazole or esomeprazole can reduce its antiplatelet activity. This connection should prompt review of the complete medicine list with a pharmacist or prescriber, not a sudden self-stop, timing change or replacement of either medicine after reading online.
SOURCE EVIDENCE REGISTER
Source evidence map
Every public link is labelled with its market, document status and document type. A historical public record is not a current label, and an official lookup entry is not a product-specific record.
- DailyMed (NLM): PRILOSEC OTC omeprazole magnesium delayed-release-tablet public label (P&G; SPL v2) ↗reviewed 2026-08-20
- FDA: PRILOSEC 2010-08 prescribing information ↗Historical public record · reviewed 2026-08-20
- FDA Drugs@FDA ↗Official lookup entry · reviewed 2026-08-20
SOURCE-TRACEABLE ARCHIVE
Prilosec OTComeprazole
This page includes an exact current U.S. public-label package panel for Prilosec OTC, alongside documentary primary-source material. It helps check product identity, but does not itself establish originator status, product quality, availability or sale eligibility.
DOCUMENT TIMELINE
Document timeline
Initial U.S. approval year listed in the FDA label
The FDA label archive linked here lists Initial U.S. Approval: 1989. This historical locator is not a conclusion about current approval, availability, holder or another market.
FDA: PRILOSEC label archive ↗FDA label archive version
This page links the 2010 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document.
FDA: PRILOSEC label archive ↗
MARKET SCOPE
Market-record boundary
United States
Public label archive linkedOnly the FDA document listed on this page is linked.
Mainland China, EU, Japan
Market record not establishedNo local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive.
How to read this record
Read each document in its stated market, date and dosage-form context. A historical record is not a current label and does not support individual medical, substitution or purchasing conclusions.
Keep international and mainland China records separate
This page has a U.S. public history/regulatory archive but no mainland China record for this specific product. That does not establish whether the medicine exists, is approved or is available in mainland China. Verify product identity, dosage form, strength, holder and the current label item by item.
Mainland China trade-name search cue: 洛赛克®
This cue helps read packaging and search official records. It does not establish current approval, holder, strength, originator relationship, supply or sale eligibility.
RECORD FAQ
Record questions
Does a label archive represent current product information?
Not automatically. The archive locates a source; each point needs verification against the target market’s current official label.
Why are price and originator/generic conclusions not shown?
Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient.
READ NEXT
Related reading
Evidence status
The listed links are public sources selected for traceability. They must be rechecked against the current target-market record before any use beyond reading and research.