{ "id": "omeprazole-prilosec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Prilosec OTC", "generic": "奥美拉唑", "aliases": [ "Prilosec", "洛赛克", "omeprazole" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "洛赛克®", "status": "discovery_cue_requires_target_market_verification", "source": null } }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 PRILOSEC OTC 非处方公开标签（DailyMed SPL v2，2025-06-10 生效/2025-06-12 发布）", "dosageFormClass": "奥美拉唑镁延迟释放片（非处方）：本档案精确展示 20 mg、42 片纸盒；不并入 PRILOSEC 处方延迟释放胶囊", "dosageFormClassCode": "oral_modified_release", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1989", "archiveSponsorText": "AstraZeneca / P&G（本页仅建立 P&G PRILOSEC OTC 标签身份）" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "PRILOSEC delayed-release capsule", "PRILOSEC capsule", "PRILOSEC 20 mg capsule", "奥美拉唑肠溶胶囊" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-prilosec-otc-tablet-20mg-84126-301-42", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v2（2025-06-10 生效；2025-06-12 发布）", "en": "DailyMed SPL v2 (effective 10 Jun 2025; published 12 Jun 2025)" }, "dosageForm": { "zh": "奥美拉唑镁延迟释放片（非处方）", "en": "omeprazole magnesium delayed-release tablet (OTC)" }, "route": { "zh": "口服（仅作标签产品身份字段）", "en": "oral (label product-identity field only)" }, "routeCodes": [ "oral" ], "productCode": "NDC 84126-301-42", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 20 mg；42 片纸盒（3 板 × 14 片）", "en": "20 mg per tablet; 42-tablet carton (3 blisters × 14 tablets)" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=301.jpg&setid=c7229a69-07e7-4690-8fc0-1f0f093bf230&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "奥美拉唑（延迟释放片）", "en": "omeprazole delayed-release tablet" }, "value": 20, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人服用片数、疗程或换算指令", "en": "labelled amount per tablet; not an individual tablet count, course or conversion instruction" } } ], "concentration": null, "container": { "typeCode": "carton", "typeLabel": { "zh": "纸盒", "en": "carton" }, "fill": null, "countPerPackage": 42, "countUnit": { "zh": "片/盒", "en": "tablets per carton" }, "unitsPerContainer": { "count": 14, "unit": { "zh": "片/泡罩板", "en": "tablets per blister" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 42, "unit": { "zh": "片/盒", "en": "tablets per carton" } }, "physicalClues": null, "comparisonNotice": null, "source": { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-prilosec-otc-tablet-20mg-84126-301-42", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=301.jpg&setid=c7229a69-07e7-4690-8fc0-1f0f093bf230&type=img", "alt": "PRILOSEC OTC 奥美拉唑镁 20 mg 延迟释放片在美国 DailyMed SPL v2 中的 42 片纸盒主展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v2（2025-06-10 生效；2025-06-12 发布）", "presentation": "PRILOSEC OTC（奥美拉唑镁）20 mg 延迟释放片、42 片纸盒（3 板 × 14 片；NDC 84126-301-42；DailyMed SPL v2 所列）。", "notice": "此图只对应美国 DailyMed SPL v2 中 PRILOSEC OTC 20 mg 延迟释放片、NDC 84126-301-42、42 片纸盒（3 板 × 14 片），只帮助核对品牌、活性成分文字、标示强度、剂型、包装数量与来源；不用于鉴定真伪，也不证明 PRILOSEC 处方胶囊、其他奥美拉唑剂型、其他包装、其他市场标签、原研身份、目标市场批准或可售资格。", "source": { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "PRILOSEC OTC 说明书放大阅读：本页的延迟释放片不等于同名处方胶囊", "en": "PRILOSEC OTC label reading: this delayed-release tablet is not the same product as a same-name prescription capsule" }, "summary": { "zh": "本模块先以美国 DailyMed 2025 PRILOSEC OTC 延迟释放片为精确包装阅读入口，再用 FDA 2010 历史资料说明同名处方胶囊和缓释口服混悬液为何不能混同；不把标签中的治疗表转化为个人处方或自行用药指令。", "en": "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." }, "checks": [ { "zh": "本页精确展示的是 PRILOSEC OTC 延迟释放片 20 mg、42 片纸盒（3 板 × 14 片）。它不代表 PRILOSEC 处方延迟释放胶囊、缓释口服混悬液或其他奥美拉唑产品；同名、同为 20 mg 或包装数字相近，都不表示可自行互换。", "en": "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." }, { "zh": "“缓释/肠溶”描述的是制剂如何设计释放和通过胃部环境，不是“效果更强”或“可以把一颗掰成两次吃”的通用结论。是否能打开、撒服、掰开、研碎或改用另一剂型，只能按该准确产品的现行标签和药师指导确认。", "en": "“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." }, { "zh": "该标签还列出多种可能受胃酸或代谢途径影响的联用药物。正在使用抗血小板、抗凝、抗癫痫、抗病毒、免疫抑制或其他处方药时，应带完整药单请药师核对，不要因网络上看到“胃药相互作用”而自行停用、替换或加药。", "en": "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.”" }, { "zh": "本页的精确包装来自美国 2025 OTC 标签，而用于说明处方胶囊/混悬液区别的 FDA 文件是 2010 历史资料；两者都不能证明中国或其他市场的现行规格、包装、适应症或可获得性。出现吞咽困难、呕血、黑便、胸痛等健康问题时不应只靠网页自行判断。", "en": "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." } ], "source": { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息（缓释剂型、规格与相互作用）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "奥美拉唑怎样起作用：它作用于胃壁细胞的“质子泵”", "en": "How omeprazole works: it acts on the gastric parietal-cell “proton pump”" }, "summary": { "zh": "FDA 的 PRILOSEC 公开药理资料描述：奥美拉唑通过特异性抑制胃壁细胞分泌表面的 H⁺/K⁺ ATPase 酶系统来抑制胃酸分泌；这一系统常被称为胃黏膜中的“质子泵”。这解释的是药物作用路径，不是针对任何个人症状、疗程、胶囊数或联用安排的答案。", "en": "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." }, "checks": [ { "zh": "把“质子泵”理解为胃酸生成路径中的一个末端环节即可。它说明为什么奥美拉唑属于抑酸药，但不能从机制反推某个人胃痛、反酸、咳嗽或胸部不适的原因，更不能替代诊断和目标市场的现行标签。", "en": "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." }, { "zh": "肠溶/缓释胶囊与缓释口服混悬液都可能含奥美拉唑，却有不同的剂型、单位与操作要求。共同机制不让它们自动变成相同的胶囊数、毫升数或可随意打开、掰开、研碎和互换的产品。", "en": "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." }, { "zh": "PRILOSEC 标签列有需要复核的联用药物；PLAVIX 现行美国标签还特别提示奥美拉唑或埃索美拉唑可能降低其抗血小板活性。这个关联应促使带完整药单请药师或开方团队核对，而不是在网上看到后自行突然停用、错开时间或替换任何一种药。", "en": "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": { "id": "src_b96c539794d3017b", "label": "FDA：PRILOSEC 公开药理资料（Mechanism of Action）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2004/19810se8-058%2Cslr003_prilosec_lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Prilosec OTC", "generic": "奥美拉唑", "dosageFormClass": "奥美拉唑镁延迟释放片（非处方）：本档案精确展示 20 mg、42 片纸盒；不并入 PRILOSEC 处方延迟释放胶囊" }, "labelSource": { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "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." } }, { "source": { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "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." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "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." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary 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." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’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." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’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." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health 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." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’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." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’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." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2012-ppi-cdad-prilosec-otc-safety-communication", "issuedAt": "2012-02-08", "status": "fda_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括 Prilosec OTC 在内的 PPI 与艰难梭菌相关性腹泻风险沟通", "en": "FDA Drug Safety Communication: C. difficile-associated diarrhoea communication for PPIs including Prilosec OTC" }, "summary": { "zh": "FDA 于 2012-02-08 发布质子泵抑制剂（PPI）类别安全通讯，说明该类胃酸抑制药与艰难梭菌相关性腹泻（CDAD）风险增加可能有关；FDA 当前 OTC 胃灼热页面将 Prilosec OTC（奥美拉唑镁）列为 PPI，并链接该安全通讯。此记录是美国、特定日期的类别沟通，不能诊断腹泻原因，不能推断手中 PRILOSEC OTC 20 mg 延迟释放片、处方奥美拉唑、其他 PPI 或其他市场产品的个人风险，也不支持自行停用、加减、延长疗程或更换酸抑制药。持续不改善的腹泻或其他急性不适应及时寻求当地医疗支持，并让药师或开方团队核对实际包装、完整用药清单和现行标签。", "en": "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." }, "source": { "id": "src_16fec3b73d115843", "label": "FDA：2012-02-08 PPI 与艰难梭菌相关性腹泻药物安全通讯（Prilosec OTC 列于 FDA 当前 PPI 页面）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/anda/2012/202194Orig1s000.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "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." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页精确建立美国 PRILOSEC OTC（omeprazole magnesium）20 mg 延迟释放片、42 片纸盒的标签阅读身份；不把同名 PRILOSEC 处方延迟释放胶囊、其他奥美拉唑胶囊、其他包装或其他市场产品混为同一产品。页面不构成诊疗、疗程、处方、购买或当前可得性建议。", "history": "PRILOSEC 是奥美拉唑品牌历史中的名称线索，但本档案的精确产品卡只对应美国 DailyMed 所列 PRILOSEC OTC 延迟释放片。剂型、包装、适应症与可及性均应以所在市场的当前监管资料为准。", "sourceDocuments": [ { "id": "src_4c50d84de0d65431", "label": "DailyMed（NLM）：PRILOSEC OTC 奥美拉唑镁延迟释放片公开标签（P&G；SPL v2）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=c7229a69-07e7-4690-8fc0-1f0f093bf230", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_0f7991f28ecf7d2e", "label": "FDA：PRILOSEC 2010-08 处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090%2C022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 019810 / 022056", "approvalTimeline": [ { "date": "1989", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1989。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "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." }, "source": { "id": "src_4188c446359491f2", "label": "FDA: PRILOSEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "2010", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 2010 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "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." }, "source": { "id": "src_4188c446359491f2", "label": "FDA: PRILOSEC label archive", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2010/019810s090,022056s005lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/omeprazole-prilosec/", "en": "https://origindrug.com/en/drugs/omeprazole-prilosec/" }, "limitations": [ "No originator, generic, interchangeability, availability, price, holder, strength or sale-eligibility conclusion is inferred beyond the linked source documents.", "Target-market current labels and official records must be checked separately." ] }