{ "id": "advil-tablets", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-19", "status": "published_traceable_archive" }, "names": { "brand": "Advil", "generic": "布洛芬", "aliases": [ "ADVIL TABLETS", "Advil Coated Tablets", "ibuprofen" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "疼痛与炎症", "sourceArchiveMarket": "美国当前 NDA 018989 非处方标签；DailyMed SPL v38 于 2026-03-12 生效、2026-03-16 发布", "dosageFormClass": "口服包衣片：每片布洛芬 200 mg；本档案精确展示 NDC 0573-0150-20 的 24 片瓶装", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "1984-05-18（DailyMed 当前标签所列美国营销起始节点）", "archiveSponsorText": "Haleon US Holdings LLC / DailyMed（NLM）当前公开 OTC 标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "Advil Tablets", "Advil Coated Tablets" ], "excludedProductCues": [ "ADVIL PM", "diphenhydramine", "acetaminophen", "ADVIL Liqui-Gels", "ADVIL Liqui Gels", "ADVIL Minis", "ADVIL liquid-filled capsule", "ADVIL Gel Caplets", "ADVIL Caplets", "ADVIL Dual Action", "ADVIL Cold", "ADVIL Cold & Sinus", "ADVIL Sinus", "ADVIL Flu", "Children's ADVIL", "Infants ADVIL", "ADVIL suspension", "ADVIL drops", "ADVIL Migraine", "ADVIL Targeted Relief", "ADVIL topical", "ADVIL ibuprofen sodium", "compare to Advil", "repackaged" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-advil-tablets-200mg-ndc-0573-0150-20", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v38；2026-03-12 生效，2026-03-16 发布", "en": "DailyMed SPL v38; effective 12 Mar 2026 and published 16 Mar 2026" }, "dosageForm": { "zh": "包衣片", "en": "coated tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 0573-0150-20", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片 200 mg；24 片瓶装", "en": "200 mg per tablet; 24-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89&name=Advil+Tablets+24+ct.jpg", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "布洛芬", "en": "ibuprofen" }, "value": 200, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签含量；不是个人服用片数", "en": "labelled amount per tablet/caplet; not an individual's tablet count" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "24 片瓶装", "en": "24-tablet bottle" }, "fill": null, "countPerPackage": 24, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-19", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 24, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉棕色", "en": "pinkish brown" }, "shape": { "zh": "11 mm 圆片", "en": "11 mm round tablet" }, "imprint": "Advil", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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-advil-tablets-200mg-ndc-0573-0150-20", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89&name=Advil+Tablets+24+ct.jpg", "alt": "Advil 当前美国 DailyMed v38 标签中的布洛芬 200 mg、NDC 0573-0150-20、24 片瓶装包装展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v38（2026-03-12 生效；2026-03-16 发布）", "presentation": "Advil 布洛芬 200 mg 包衣片；NDC 0573-0150-20；24 片瓶装", "notice": "此图只对应美国当前标签中的圆形包衣片 24 片瓶装。它不代表 Liqui-Gels、caplet、PM、Dual Action、儿童液体、其他包装或其他市场，也不用于鉴定真伪或判断个人片数。", "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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": "ADVIL 说明书放大阅读：200 mg 先确认准确包衣片，再核对 NSAID 重复", "en": "ADVIL label reading: 200 mg first identifies the exact coated tablet, then check duplicate NSAIDs" }, "summary": { "zh": "本模块只帮助核对准确 Advil 包衣片、每片布洛芬、包装及 Drug Facts 风险；不提供个人片数、间隔、疗程、漏用、停药或替代方案。", "en": "This module only helps check the exact Advil coated tablet, ibuprofen per tablet, package and Drug Facts risks; it provides no personal tablet count, interval, duration, missed-use, stopping or substitution plan." }, "checks": [ { "zh": "布洛芬属于非甾体抗炎药（NSAID）。检查阿司匹林、萘普生、布洛芬及其他止痛、感冒或处方药是否造成同类成分重复；不要因品牌不同就自行叠加。", "en": "Ibuprofen is a nonsteroidal anti-inflammatory drug (NSAID). Check aspirin, naproxen, ibuprofen and other pain, cold or prescription medicines for class or ingredient overlap; different brands do not permit self-combination." }, { "zh": "标签提示胃出血风险，尤其是 60 岁以上、有溃疡或出血史、使用抗凝药/类固醇/其他 NSAID 或饮酒较多的人。黑便、呕血、持续胃痛或晕厥应及时使用当地医疗支持。", "en": "The label warns about stomach bleeding, especially for people aged 60 or older, with ulcer or bleeding history, or using anticoagulants, steroids, other NSAIDs or more alcohol. Black stools, vomiting blood, persistent stomach pain or fainting warrants timely local medical support." }, { "zh": "肾脏疾病、利尿剂、多种心血管药或脱水等情况需要医生或药师结合完整药单复核；网页不会提供所谓安全肾功能阈值或个人方案。", "en": "Kidney disease, diuretics, multiple cardiovascular medicines or dehydration require clinician or pharmacist review of the complete medicine list; this page provides no supposed safe kidney threshold or personal plan." }, { "zh": "妊娠 20 周或以后使用 NSAID 需要按当前标签和 FDA 安全信息与专业人员讨论。页面不根据孕周自行判断能否使用。", "en": "NSAID use at 20 weeks of pregnancy or later requires discussion with a professional using the current label and FDA safety information. This page does not decide suitability from gestational age." }, { "zh": "若正在使用低剂量阿司匹林作预防，不要依据网页自行停用、错开或替换；把阿司匹林、布洛芬、萘普生和全部药盒交给医生或药师核对。", "en": "If low-dose aspirin is used for prevention, do not stop, space or replace it from a webpage; have a clinician or pharmacist review aspirin, ibuprofen, naproxen and every medicine pack together." } ], "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "布洛芬怎样起作用：NSAID 类别说明不等于个人用药方案", "en": "How ibuprofen works: an NSAID class explanation is not an individual regimen" }, "summary": { "zh": "当前标签将布洛芬归入 NSAID。该类别说明帮助理解疼痛、炎症以及胃肠、心血管和肾脏风险为何需要一起核对；不会决定个人是否适用、片数、间隔或疗程。", "en": "The current label places ibuprofen in the NSAID class. That context helps explain why pain, inflammation, gastrointestinal, cardiovascular and kidney risks need review together; it does not determine personal suitability, tablet count, interval or duration." }, "checks": [ { "zh": "相同 NSAID 类别或相同 200 mg 不使另一种布洛芬、萘普生、阿司匹林或复方产品可以自行叠加或替换。", "en": "A shared NSAID class or 200 mg marking does not make another ibuprofen, naproxen, aspirin or combination product self-combinable or substitutable." }, { "zh": "包衣片、caplet、Liqui-Gels、儿童液体和外用产品属于不同产品身份，不能只凭品牌或通用名合并。", "en": "Coated tablets, caplets, Liqui-Gels, children's liquids and topical products are different product identities and cannot be collapsed by brand or generic name alone." }, { "zh": "胸痛、呼吸困难、突发无力、严重胃肠道出血表现、明显少尿或急性过敏等情况应使用当地紧急医疗支持。", "en": "Chest pain, breathing difficulty, sudden weakness, serious gastrointestinal bleeding signs, markedly reduced urine or acute allergy warrants local urgent medical support." } ], "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Advil", "generic": "布洛芬", "dosageFormClass": "口服包衣片：每片布洛芬 200 mg；本档案精确展示 NDC 0573-0150-20 的 24 片瓶装" }, "labelSource": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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" }, "productRoutes": [ { "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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": "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." } }, "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-2020-nsaid-pregnancy-20-weeks-ibuprofen-advil-safety-communication", "issuedAt": "2020-10-15", "status": "fda_ingredient_class_safety_communication", "title": { "zh": "FDA 药物安全通讯：包括布洛芬的 NSAIDs 在妊娠约 20 周后的风险沟通", "en": "FDA Drug Safety Communication: NSAID risk communication in pregnancy at about 20 weeks or later, including ibuprofen" }, "summary": { "zh": "FDA 于 2020-10-15 发布 NSAIDs 药物安全通讯，明确列出 ibuprofen（布洛芬），并说明该风险沟通覆盖处方与非处方 NSAIDs：妊娠约 20 周或之后使用可能与胎儿肾功能问题和羊水过少有关。Advil 档案以布洛芬这一成分线索关联此美国、特定日期的类别监管沟通；它不表示任何一盒 Advil、任何其他布洛芬产品、其他市场或任何个人已发生问题，也不支持自行开始、停止、换药、改量或用另一种止痛药替代。妊娠、疑似妊娠、疼痛或发热相关问题，应连同准确产品、现行目标市场标签和完整药单由开方团队或药师核对。", "en": "On 2020-10-15, FDA issued an NSAID Drug Safety Communication that explicitly names ibuprofen and says the risk communication applies to prescription and over-the-counter NSAIDs: use at about 20 weeks of pregnancy or later may be associated with fetal kidney problems and low amniotic fluid. The Advil dossier links this dated U.S. class communication through ibuprofen as its active-ingredient clue. It does not mean that any Advil pack, another ibuprofen product, another market or any individual has a problem, and it does not support self-starting, stopping, switching, changing an amount or replacing pain medicine. Pregnancy, suspected pregnancy, pain or fever questions require review of the exact product, current target-market label and complete medicine list with the prescribing team or pharmacist." }, "source": { "id": "src_a2dd38c41a9b7aa8", "label": "FDA：2020-10-15 NSAIDs 在妊娠约 20 周后使用的药物安全通讯（明确列出 ibuprofen）", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/fda-recommends-avoiding-use-nsaids-pregnancy-20-weeks-or-later-because-they-can-result-low-amniotic", "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": "DailyMed 当前 v38 的 Advil 标签包含多种产品呈现；本档案只精确展示 NDC 0573-0150-20：布洛芬 200 mg 包衣片，24 片瓶装。页面帮助核对成分、片型、NDC、包装和 NSAID 重复风险；不生成个人片数、间隔、疗程、漏服处理、与阿司匹林的安排或换药建议。", "history": "Advil 的美国 NDA 018989 与 1984 年节点可由当前公开标签追溯。由于同一品牌家族包含 caplet、gel、PM、复方和儿童产品，本页只以准确 NDC、剂型和官方图绑定所选圆形包衣片。", "sourceDocuments": [ { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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" } ], "applicationNumber": "NDA 018989", "approvalTimeline": [ { "date": "1984-05-18", "title": { "zh": "当前标签所列美国营销起始节点", "en": "U.S. marketing start node listed in the current label" }, "detail": { "zh": "该节点用于追溯 NDA 018989 的美国产品历史，不说明其他市场或其他 Advil 家族产品。", "en": "This node supports U.S. product history for NDA 018989 and does not establish another market or another Advil-family product." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed: current ADVIL public label, SPL v38", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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" } }, { "date": "2026-03-12 / 2026-03-16", "title": { "zh": "SPL v38 生效与发布时间", "en": "SPL v38 effective and publication dates" }, "detail": { "zh": "当前标签于 2026-03-12 生效、2026-03-16 发布；本档案只精确展示 NDC 0573-0150-20 的 24 片瓶装圆形包衣片。", "en": "The current label became effective 12 Mar 2026 and was published 16 Mar 2026; this dossier displays only the 24-tablet round coated-tablet bottle, NDC 0573-0150-20." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed: current ADVIL public label, SPL v38", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 NDA 018989 标签与一个精确包装已链接", "en": "Current NDA 018989 label and one exact package linked" }, "detail": { "zh": "截至 2026-08-19 已核对 SPL v38 与 NDC 0573-0150-20；不据此声称实际在售、库存或可获得性。", "en": "SPL v38 and NDC 0573-0150-20 were reviewed through 19 Aug 2026; this does not establish actual marketing, stock or availability." } }, { "market": { "zh": "其他 Advil 产品与其他市场", "en": "Other Advil products and other markets" }, "status": { "zh": "明确分开或待建立", "en": "Explicitly separate or not established" }, "detail": { "zh": "Liqui-Gels、caplet、PM、Dual Action、儿童液体及其他市场不并入本包衣片展示。", "en": "Liqui-Gels, caplets, PM, Dual Action, children's liquids and other markets are not merged into this coated-tablet presentation." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "正在使用阿司匹林，可以自己改用 Advil 或调整时间吗？", "en": "Can someone using aspirin self-switch to Advil or adjust timing?" }, "answer": { "zh": "不能由网页决定。不要自行停用预防性阿司匹林；应把阿司匹林、布洛芬、萘普生及完整药单交给医生或药师核对。", "en": "A webpage cannot decide this. Do not self-stop preventive aspirin; have a clinician or pharmacist review aspirin, ibuprofen, naproxen and the complete medicine list." } } ], "relatedMedicineChecks": [ { "target": { "id": "coumadin", "brand": "Coumadin", "generic": "华法林钠", "canonicalUrls": { "zh": "https://origindrug.com/drugs/coumadin/", "en": "https://origindrug.com/en/drugs/coumadin/" } }, "title": { "zh": "与 COUMADIN／华法林同在药单上时：抗凝药是需要优先核对的风险线索", "en": "When COUMADIN / warfarin is on the same list: an anticoagulant is a priority review cue" }, "summary": { "zh": "ADVIL 当前美国公开 Drug Facts 将正在使用抗凝药列为胃出血警示中需要留意的风险线索。本卡片只提示把实际 Advil 包装、华法林包装、其他止痛/感冒药、处方药、非处方药和补充剂交给负责团队核对；它不判断能否同服，也不建议自行停用、错开时间、替换或调整任何一种药。", "en": "The current U.S. public Drug Facts for ADVIL lists use of a blood-thinning anticoagulant as a risk cue in its stomach-bleeding warning. This card only signals that the actual Advil pack, warfarin pack, other pain/cold products, prescription medicines, OTC products and supplements need review by the responsible team; it does not decide co-use or advise self-stopping, time-separation, replacement or adjustment of either medicine." }, "source": { "id": "src_a0ff83312e9e0cbd", "label": "DailyMed（NLM）：ADVIL 布洛芬当前美国公开标签（Haleon；SPL v38）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1a665e64-9f30-be37-4a83-38789f1f1e89", "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": "review_complete_medicine_list_no_self_directed_change" } ], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/advil-tablets/", "en": "https://origindrug.com/en/drugs/advil-tablets/" }, "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." ] }