{
  "id": "tylenol-extra-strength",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-19",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Tylenol Extra Strength",
    "generic": "对乙酰氨基酚",
    "aliases": [
      "TYLENOL EXTRA STRENGTH",
      "Extra Strength Tylenol",
      "acetaminophen",
      "paracetamol",
      "APAP"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "疼痛与炎症",
    "sourceArchiveMarket": "美国当前 OTC monograph 标签；DailyMed SPL v16 于 2026-07-22 生效、2026-07-24 发布",
    "dosageFormClass": "口服薄膜衣片（标签称 caplet）：每片对乙酰氨基酚 500 mg；本档案精确展示 NDC 50580-937-50",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "美国 OTC monograph M013 当前标签档案（DailyMed SPL v16）",
    "archiveSponsorText": "Kenvue Brands LLC / DailyMed（NLM）当前公开 OTC 标签档案"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "Tylenol Extra Strength",
      "Extra Strength Tylenol"
    ],
    "excludedProductCues": [
      "TYLENOL PM",
      "PM Extra Strength",
      "diphenhydramine",
      "phenylephrine",
      "dextromethorphan",
      "guaifenesin",
      "TYLENOL Nighttime",
      "TYLENOL Cold",
      "TYLENOL Cold + Flu",
      "TYLENOL Flu",
      "TYLENOL Sinus",
      "TYLENOL Cough",
      "TYLENOL Severe",
      "TYLENOL 8HR",
      "TYLENOL 8 HR",
      "Tylenol Extended Release",
      "TYLENOL 650 mg",
      "Children's TYLENOL",
      "Infants TYLENOL",
      "TYLENOL oral suspension",
      "TYLENOL chewable",
      "TYLENOL Rapid Release Gels",
      "TYLENOL Liquid Gels",
      "TYLENOL Dissolve Packs",
      "TYLENOL Adult Liquid",
      "TYLENOL Easy to Swallow",
      "TYLENOL Gentleglide",
      "50580-472",
      "compare to Tylenol",
      "repackaged"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-tylenol-extra-strength-500mg-ndc-50580-937-50",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v16；2026-07-22 生效，2026-07-24 发布",
        "en": "DailyMed SPL v16; effective 22 Jul 2026 and published 24 Jul 2026"
      },
      "dosageForm": {
        "zh": "薄膜衣片（标签称 caplet）",
        "en": "film-coated caplet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 50580-937-50",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片 500 mg；每盒 50 袋，每袋 2 片",
        "en": "500 mg per caplet; 50 pouches, 2 caplets each"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&name=tylenol-1.jpg&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "对乙酰氨基酚",
            "en": "acetaminophen"
          },
          "value": 500,
          "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": "pouch_carton",
        "typeLabel": {
          "zh": "单袋装薄膜衣片外盒",
          "en": "carton of individual caplet pouches"
        },
        "fill": null,
        "countPerPackage": 50,
        "countUnit": {
          "zh": "袋/盒",
          "en": "pouches per carton"
        },
        "unitsPerContainer": {
          "count": 2,
          "unit": {
            "zh": "片/袋",
            "en": "caplets per pouch"
          }
        }
      },
      "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": 50,
        "unit": {
          "zh": "袋/盒",
          "en": "pouches per carton"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色、红色印字",
          "en": "white with red print"
        },
        "shape": {
          "zh": "19 mm 椭圆片",
          "en": "19 mm oval caplet"
        },
        "imprint": "TYLENOL;500",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_5996c8561aae7112",
        "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
        "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-tylenol-extra-strength-500mg-ndc-50580-937-50",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&name=tylenol-1.jpg&type=img",
    "alt": "Tylenol Extra Strength 当前美国 DailyMed v16 标签中的 500 mg、NDC 50580-937-50、50 袋装包装展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed SPL v16（2026-07-22 生效；2026-07-24 发布）",
    "presentation": "Tylenol Extra Strength 对乙酰氨基酚 500 mg；NDC 50580-937-50；50 袋/盒，每袋 2 片",
    "notice": "此图只对应美国当前 v16 标签中的 NDC 50580-937-50 袋装展示。每袋 2 片是包装身份，不是个人一次服用量；它不代表 100 片瓶装、PM、感冒复方、8HR、儿童制剂、凝胶或其他市场，也不用于鉴定真伪。",
    "source": {
      "id": "src_5996c8561aae7112",
      "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
      "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": "TYLENOL Extra Strength 说明书放大阅读：先核对每片 500 mg 与重复成分",
      "en": "TYLENOL Extra Strength label reading: first check 500 mg per caplet and duplicate ingredients"
    },
    "summary": {
      "zh": "本模块只帮助核对准确产品、每片成分、包装结构和 Drug Facts 警示；不提供个人片数、服用间隔、日程、最大量、漏用处理或换算。",
      "en": "This module only helps check the exact product, ingredient per caplet, package structure and Drug Facts warnings; it provides no personal tablet count, interval, schedule, maximum amount, missed-use action or conversion."
    },
    "checks": [
      {
        "zh": "检查其他处方药与非处方药是否也含对乙酰氨基酚；不同品牌名并不能排除重复成分。不能确定时，把所有药盒和完整药单交给药师或医生核对。",
        "en": "Check whether other prescription or OTC medicines also contain acetaminophen; different brand names do not rule out a duplicate ingredient. If uncertain, take every pack and the complete medicine list to a pharmacist or clinician."
      },
      {
        "zh": "标签中的 4,000 mg/24 小时是严重肝损伤警告边界，不是推荐目标、个人上限计算器或网页用量方案。肝病、每日饮用三杯或以上酒精饮品、使用华法林等情况应先咨询医生或药师。",
        "en": "The label's 4,000 mg in 24 hours is a severe liver-damage warning boundary, not a target, personal-limit calculator or web regimen. Liver disease, three or more alcoholic drinks daily, warfarin and related situations require clinician or pharmacist review."
      },
      {
        "zh": "本标签的年龄分组不能转成儿童个人剂量。12 岁以下、妊娠或哺乳，以及症状持续或加重时，应按准确标签联系医生或药师。",
        "en": "The label's age grouping cannot be turned into an individual child dose. For children under 12, pregnancy or breastfeeding, or persistent or worsening symptoms, use the exact label and contact a clinician or pharmacist."
      },
      {
        "zh": "疑似过量时，即使暂时没有症状，也应立即寻求医疗帮助或联系当地毒物咨询/急救渠道；网页不能计算‘还可以吃多少’。",
        "en": "For suspected overdose, seek medical help or local poison-control/emergency support immediately even without symptoms; a webpage cannot calculate how much more could be taken."
      },
      {
        "zh": "当前 Drug Facts 没有给出通用漏服规则；页面不会编造补服、加倍或改时间建议。该展示片无刻痕，标签也未授权网页判断能否掰开、压碎或研磨。",
        "en": "The current Drug Facts provides no general missed-use rule; this page does not invent a catch-up, double-use or timing instruction. This displayed caplet is unscored, and the label does not authorise a webpage to decide splitting, crushing or grinding."
      }
    ],
    "source": {
      "id": "src_5996c8561aae7112",
      "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
      "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": "对乙酰氨基酚的作用说明：公开标签不能替代个人判断",
      "en": "Acetaminophen action context: a public label does not replace individual assessment"
    },
    "summary": {
      "zh": "本页只说明该产品属于含对乙酰氨基酚的非处方镇痛退热药；不会把类别说明变成个人适用性、片数、间隔或疗程。",
      "en": "This page only identifies the product as an OTC analgesic and fever reducer containing acetaminophen; it does not turn a category description into personal suitability, tablet count, interval or duration."
    },
    "checks": [
      {
        "zh": "相同用途或相同成分名不表示不同强度、延释、儿童液体、复方感冒药或 PM 产品可以自行互换。",
        "en": "A shared use or ingredient name does not make different strengths, extended-release forms, children's liquids, combination cold products or PM products self-interchangeable."
      },
      {
        "zh": "包装上的 500 mg 是每片成分身份，不是从体重、症状或其他药物推导个人片数的公式。",
        "en": "The 500 mg on the package identifies ingredient amount per caplet; it is not a formula for deriving a personal tablet count from weight, symptoms or other medicines."
      },
      {
        "zh": "急性严重不适、过敏、严重皮肤反应或疑似过量时，应使用当地医疗和急救支持，而不是等待网页给出方案。",
        "en": "For an acute serious concern, allergy, severe skin reaction or suspected overdose, use local medical and emergency support rather than wait for a web plan."
      }
    ],
    "source": {
      "id": "src_5996c8561aae7112",
      "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
      "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": "Tylenol Extra Strength",
      "generic": "对乙酰氨基酚",
      "dosageFormClass": "口服薄膜衣片（标签称 caplet）：每片对乙酰氨基酚 500 mg；本档案精确展示 NDC 50580-937-50"
    },
    "labelSource": {
      "id": "src_5996c8561aae7112",
      "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
      "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_5996c8561aae7112",
          "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
          "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": [],
    "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 v16 将本展示对象列为 Tylenol Extra Strength 对乙酰氨基酚 500 mg 薄膜衣 caplet，NDC 50580-937-50：每盒 50 袋、每袋 2 片。每袋片数是包装身份，不是一次服用片数。本页帮助核对品牌、成分、每片含量、包装和重复成分风险；不生成个人片数、间隔、日程、最大量、漏服补救或换算。",
    "history": "本档案只把 2026-07-22 生效、2026-07-24 发布的 DailyMed v16 当前包装图与 NDC 50580-937-50 绑定。历史 v15 的 100 片瓶装图 tylenol-01.jpg（archive 944219）不作为当前展示，也不与现行 tylenol-1.jpg 混配。",
    "sourceDocuments": [
      {
        "id": "src_5996c8561aae7112",
        "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
        "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_38bff872e618edee",
        "label": "FDA：OTC Monograph M013 Final Administrative Order OTC000027",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Final%20Administrative%20Order%20OTC000027_M013-Internal%20Analgesic.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "publication_status_unresolved",
        "documentKind": "regulatory_reference",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      }
    ],
    "applicationNumber": "OTC Monograph M013 / Final Order OTC000027",
    "approvalTimeline": [
      {
        "date": "2026-07-22",
        "title": {
          "zh": "当前 DailyMed SPL v16 生效",
          "en": "Current DailyMed SPL v16 became effective"
        },
        "detail": {
          "zh": "本档案将 v16 的精确 NDC、每片 500 mg 与 50 袋×每袋 2 片包装分开记录。OTC monograph 与 NDC 列示不等同于药品申请获批结论。",
          "en": "This dossier records the exact NDC, 500 mg per caplet and the 50-pouch × 2-caplet package separately. OTC monograph and NDC listing do not mean FDA approval."
        },
        "source": {
          "id": "src_5996c8561aae7112",
          "label": "DailyMed: current TYLENOL Extra Strength public label, SPL v16",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
          "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": "2026-07-24",
        "title": {
          "zh": "DailyMed 发布当前 v16",
          "en": "DailyMed published current v16"
        },
        "detail": {
          "zh": "发布日期与标签生效日分开记录；当前包装图只绑定 NDC 50580-937-50。",
          "en": "Publication date remains separate from label effective date; the current package image is bound only to NDC 50580-937-50."
        },
        "source": {
          "id": "src_5996c8561aae7112",
          "label": "DailyMed: current TYLENOL Extra Strength public label, SPL v16",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
          "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": "OTC000027",
        "title": {
          "zh": "FDA M013 最终行政命令来源",
          "en": "FDA M013 final administrative order source"
        },
        "detail": {
          "zh": "FDA 的 OTC000027 文件为 M013 内用镇痛药 monograph 的一手监管入口；该制度路径与药品申请获批记录分开。",
          "en": "FDA OTC000027 is a primary regulatory source for the M013 internal-analgesic monograph; this pathway remains distinct from an approved drug application."
        },
        "source": {
          "id": "src_38bff872e618edee",
          "label": "FDA: OTC Monograph M013 Final Administrative Order OTC000027",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/omuf/Order/Final%20Administrative%20Order%20OTC000027_M013-Internal%20Analgesic.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "publication_status_unresolved",
          "documentKind": "regulatory_reference",
          "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": "当前 OTC monograph 标签与精确包装已链接",
          "en": "Current OTC monograph label and exact package linked"
        },
        "detail": {
          "zh": "截至 2026-08-19 已核对 SPL v16 与 NDC 50580-937-50；不据此声称药品申请获批、实际在售、库存或可获得性。",
          "en": "SPL v16 and NDC 50580-937-50 were reviewed through 19 Aug 2026; this does not establish FDA approval, actual marketing, stock or availability."
        }
      },
      {
        "market": {
          "zh": "中国大陆及其他市场",
          "en": "Mainland China and other markets"
        },
        "status": {
          "zh": "待逐项建立市场记录",
          "en": "Market record not established"
        },
        "detail": {
          "zh": "不从美国标签外推当地品牌、批准、包装、供应或可替代性。",
          "en": "No local brand, approval, package, supply or interchangeability is inferred from the U.S. label."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "每袋 2 片是不是一次要吃 2 片？",
          "en": "Does two caplets per pouch mean two caplets per use?"
        },
        "answer": {
          "zh": "不是。它只是包装身份。本页不提供个人片数、间隔或最大量；应按手上准确标签并咨询药师或医生。",
          "en": "No. It is package identity only. This page provides no personal tablet count, interval or maximum; use the exact label in hand and ask a pharmacist or clinician."
        }
      },
      {
        "question": {
          "zh": "如果漏用，能补服或加倍吗？",
          "en": "Can a missed use be made up or doubled?"
        },
        "answer": {
          "zh": "当前 Drug Facts 没有提供通用漏用规则，本页不会编造补服或加倍建议。",
          "en": "The current Drug Facts provides no general missed-use rule, so this page does not invent a catch-up or doubling instruction."
        }
      }
    ],
    "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：止痛退热药也要先核对",
          "en": "When COUMADIN / warfarin is on the same list: an analgesic or fever medicine also needs review first"
        },
        "summary": {
          "zh": "TYLENOL Extra Strength 的美国公开 Drug Facts 提示，正在使用华法林时应先咨询医生或药师。本卡片只提示把实际 TYLENOL 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 U.S. public Drug Facts for TYLENOL Extra Strength says to ask a doctor or pharmacist before use when taking warfarin. This card only signals that the actual TYLENOL 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_5996c8561aae7112",
          "label": "DailyMed（NLM）：TYLENOL Extra Strength 当前美国公开标签（Kenvue；SPL v16）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=103d109d-f520-409c-8da2-eb6b0fbec891&version=16",
          "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/tylenol-extra-strength/",
    "en": "https://origindrug.com/en/drugs/tylenol-extra-strength/"
  },
  "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."
  ]
}