{
  "id": "panadol-extra-strength",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-13",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Panadol Extra Strength",
    "generic": "对乙酰氨基酚",
    "aliases": [
      "PANADOL EXTRA STRENGTH",
      "Panadol 500",
      "PANADOL 500 mg",
      "必理痛加强型",
      "acetaminophen",
      "paracetamol",
      "APAP",
      "对乙酰氨基酚"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "疼痛与炎症",
    "sourceArchiveMarket": "美国：DailyMed SPL v8，2024-02-07 发布；本页精确对应 PANADOL Extra Strength 对乙酰氨基酚 500 mg 薄膜衣片的标签文件。该有日期文件不证明其他国家/地区、PANADOL 其他产品线或当前供应状态。",
    "dosageFormClass": "对乙酰氨基酚口服薄膜衣 caplet：每片 500 mg；本页精确展示 DailyMed 标签中的 NDC 0135-7011-04、100 片瓶装面板",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "美国 OTC monograph M013 有日期公开标签档案（DailyMed SPL v8）",
    "archiveSponsorText": "Haleon US Holdings LLC / DailyMed（NLM）有日期公开 OTC 标签档案"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "Panadol Extra Strength",
      "PANADOL EXTRA STRENGTH",
      "Panadol 500"
    ],
    "excludedProductCues": [
      "PANADOL PM",
      "diphenhydramine",
      "PANADOL Cold",
      "PANADOL COLD AND FLU",
      "dextromethorphan",
      "phenylephrine",
      "chlorpheniramine",
      "PANADOL EXTRA caffeine",
      "Panadol suspension",
      "Panadol liquid",
      "Children's Panadol",
      "PANADOL 665",
      "extended release",
      "modified release"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-panadol-extra-strength-500mg-ndc-0135-7011-04",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v8；2024-02-07 发布",
        "en": "DailyMed SPL v8; published 7 Feb 2024"
      },
      "dosageForm": {
        "zh": "薄膜衣 caplet",
        "en": "film-coated caplet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0135-7011-04",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片 500 mg；100 片/瓶",
        "en": "500 mg per caplet; 100 caplets per bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138&name=image-01.jpg",
      "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": "bottle",
        "typeLabel": {
          "zh": "100 片瓶装",
          "en": "100-caplet bottle"
        },
        "fill": null,
        "countPerPackage": 100,
        "countUnit": {
          "zh": "片/瓶",
          "en": "caplets 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": 100,
        "unit": {
          "zh": "片/瓶",
          "en": "caplets per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "标签图所示白色 caplet",
          "en": "white caplet as displayed in the label image"
        },
        "shape": {
          "zh": "标签图所示 caplet",
          "en": "caplet as displayed in the label image"
        },
        "imprint": null,
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_0a2074c250f9960e",
        "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
        "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-panadol-extra-strength-500mg-ndc-0135-7011-04",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138&name=image-01.jpg",
    "alt": "PANADOL Extra Strength 在 DailyMed 有日期美国标签中的对乙酰氨基酚 500 mg、NDC 0135-7011-04、100 片瓶装展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed SPL v8（2024-02-07 发布）",
    "presentation": "PANADOL Extra Strength 对乙酰氨基酚 500 mg；NDC 0135-7011-04；100 片瓶装",
    "notice": "此图只对应该美国有日期标签中的 PANADOL Extra Strength 500 mg、NDC 0135-7011-04、100 片瓶装。100 片是包装数量，不是一次或一天的个人用量；它不代表 PANADOL PM、感冒复方、含咖啡因产品、儿童液体、缓释/其他规格或其他市场，也不用于鉴定真伪。",
    "source": {
      "id": "src_0a2074c250f9960e",
      "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
      "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": "PANADOL Extra Strength 放大阅读：500 mg 是每片含量，先核对重复成分",
      "en": "PANADOL Extra Strength label reading: 500 mg is per caplet; check duplicate ingredients first"
    },
    "summary": {
      "zh": "本模块帮助阅读准确产品、每片对乙酰氨基酚含量、100 片包装身份和该标签的 Drug Facts 警示；不提供个人片数、间隔、最大量、漏服补救或换算。",
      "en": "This module helps read the exact product, acetaminophen amount per caplet, the 100-caplet package identity and this label's Drug Facts warnings; it does not provide a personal caplet count, interval, maximum, missed-use instruction or conversion."
    },
    "checks": [
      {
        "zh": "PANADOL 名称下的 PM、感冒复方、含咖啡因产品、儿童液体和其他市场包装并不是本页这瓶 500 mg 片剂。名称相近或都写 PANADOL，不能证明成分相同或可自行替换。",
        "en": "PANADOL PM, cold combinations, caffeine-containing products, children's liquids and packs from other markets are not this 500 mg caplet record. A similar name or PANADOL branding does not establish matching ingredients or self-substitution."
      },
      {
        "zh": "查看所有处方药和非处方药是否也含对乙酰氨基酚；不同品牌名不能排除重复成分。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 every prescription and OTC product also contains acetaminophen; different brands do not rule out a duplicate ingredient. If uncertain, have a pharmacist or clinician review every pack and the complete medicine list."
      },
      {
        "zh": "标签中关于 24 小时上限、肝损伤、酒精、华法林或过敏/皮肤反应的文字是安全核对线索，不是网页为个人生成的用量目标、加量公式或换药方案。",
        "en": "The label's 24-hour limit, liver-damage, alcohol, warfarin and allergy/skin-reaction text are safety-review cues, not a web-generated target, escalation formula or switching plan for an individual."
      },
      {
        "zh": "疑似过量时，即使暂时没有症状，也应立即使用当地医疗、急救或中毒咨询支持；不要等待网页计算“还能吃多少”。",
        "en": "For suspected overdose, use local medical, emergency or poison-information support immediately even without symptoms; do not wait for a webpage to calculate how much more could be taken."
      },
      {
        "zh": "100 片是整瓶数量，500 mg 是每片成分含量；这两个数字不能相乘、相除或结合症状自行推导片数。是否可掰开、研碎或换成另一种剂型，必须以准确药盒的现行说明书和药师核对为准。",
        "en": "100 is the bottle count and 500 mg is ingredient amount per caplet. They cannot be multiplied, divided or combined with symptoms to derive a personal caplet count. Splitting, crushing or changing dosage form requires the current label for the exact pack and pharmacist review."
      }
    ],
    "source": {
      "id": "src_0a2074c250f9960e",
      "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
      "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：药盒识别不等于个人用药决定",
      "en": "Acetaminophen context: pack identification is not an individual medicine decision"
    },
    "summary": {
      "zh": "本页只将该准确产品识别为含对乙酰氨基酚的非处方镇痛退热产品；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 exact product as an OTC analgesic and fever reducer containing acetaminophen; it does not turn that category into personal suitability, caplet count, interval or duration."
    },
    "checks": [
      {
        "zh": "共同用途、共同成分或共同品牌词不表示 PANADOL 与其他对乙酰氨基酚产品、感冒复方、夜间产品或延释产品可以自行互换、叠加或轮换。",
        "en": "A shared purpose, ingredient or brand word does not establish that PANADOL and another acetaminophen, cold-combination, nighttime or extended-release product can be self-interchanged, combined or alternated."
      },
      {
        "zh": "药盒上的 500 mg 是产品身份字段，不是从体重、疼痛、发热、年龄或其他药物推导个人片数的公式。",
        "en": "The 500 mg on the pack is a product-identity field, not a formula for deriving an individual's caplet count from weight, pain, fever, age or other medicines."
      },
      {
        "zh": "出现严重不适、过敏/严重皮肤反应或疑似过量时，应优先使用当地医疗和急救支持。",
        "en": "For serious symptoms, an allergy/severe skin reaction or suspected overdose, prioritise local medical and emergency support."
      }
    ],
    "source": {
      "id": "src_0a2074c250f9960e",
      "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
      "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": "Panadol Extra Strength",
      "generic": "对乙酰氨基酚",
      "dosageFormClass": "对乙酰氨基酚口服薄膜衣 caplet：每片 500 mg；本页精确展示 DailyMed 标签中的 NDC 0135-7011-04、100 片瓶装面板"
    },
    "labelSource": {
      "id": "src_0a2074c250f9960e",
      "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
      "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_0a2074c250f9960e",
          "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
          "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": "这份档案对应美国 DailyMed 有日期标签中的 PANADOL Extra Strength：对乙酰氨基酚 500 mg 薄膜衣片，展示 NDC 0135-7011-04、100 片瓶装。500 mg 是每片的成分含量，100 片是整瓶数量；两者都不是任何人一次应该吃几片的答案。先核对药盒、是否还有其他含对乙酰氨基酚产品和完整药单，再阅读准确说明书。",
    "history": "该页面保留 2024-02-07 发布的 DailyMed SPL v8 作为有日期美国公开文件。PANADOL 名称下还存在感冒复方、PM、含咖啡因、混悬液和其他市场产品；不能因共同品牌词或 500 mg 数字把它们合并、叠加或互换。",
    "sourceDocuments": [
      {
        "id": "src_0a2074c250f9960e",
        "label": "DailyMed（NLM）：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
        "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": "OTC Monograph M013 / DailyMed SPL v8 / NDC 0135-7011-04",
    "approvalTimeline": [
      {
        "date": "2024-02-07",
        "title": {
          "zh": "DailyMed 公开 PANADOL Extra Strength SPL v8",
          "en": "DailyMed published PANADOL Extra Strength SPL v8"
        },
        "detail": {
          "zh": "本档案以 DailyMed SPL v8 的有日期公开标签，逐项绑定 PANADOL Extra Strength、对乙酰氨基酚 500 mg 薄膜衣 caplet 与 NDC 0135-7011-04 的 100 片瓶装面板。OTC monograph、NDC 与标签文件是产品识别和来源阅读入口，不等同于药品申请获批结论。",
          "en": "This dossier uses the dated DailyMed SPL v8 to bind PANADOL Extra Strength, acetaminophen 500 mg film-coated caplets and the NDC 0135-7011-04 100-caplet-bottle panel. The OTC monograph, NDC and label are product-identification and source-reading entries, not an approved-drug-application conclusion."
        },
        "source": {
          "id": "src_0a2074c250f9960e",
          "label": "DailyMed：PANADOL Extra Strength 有日期美国公开标签（Haleon；SPL v8）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=9d384e88-5c11-4600-ac6c-a38371570138",
          "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": "有日期 OTC 标签与一个精确包装面板已链接",
          "en": "Dated OTC label and one exact package panel linked"
        },
        "detail": {
          "zh": "本页只展示 SPL v8 的 500 mg caplet 与 NDC 0135-7011-04、100 片瓶装面板；它不证明当前在售、库存、可获得性、其他 NDC 或其他包装状态。",
          "en": "This page displays only the SPL v8 500 mg caplet and NDC 0135-7011-04 100-caplet-bottle panel; it does not establish current marketing, stock, availability, another NDC or another package status."
        }
      },
      {
        "market": {
          "zh": "中国大陆、其他 PANADOL 产品线及其他市场",
          "en": "Mainland China, other PANADOL lines and other markets"
        },
        "status": {
          "zh": "明确分开或待逐项建立",
          "en": "Explicitly separate or not established"
        },
        "detail": {
          "zh": "不从这份美国有日期标签推定当地品牌、批准、规格、包装、供应、可售资格、原研/仿制关系或可替代性；PM、感冒复方、含咖啡因、儿童液体和缓释/其他规格必须分别核对。",
          "en": "No local brand, approval, strength, package, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from this dated U.S. label. PM, cold combinations, caffeine-containing products, children's liquids and modified-release/other strengths require separate checking."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "100 片瓶装是否表示一次要吃 100 片或可以按包装数字算用量？",
          "en": "Does a 100-caplet bottle mean 100 caplets should be taken at once or that package numbers can calculate use?"
        },
        "answer": {
          "zh": "不是。100 片仅是该美国标签包装数量，500 mg 仅是每片成分含量。网页不提供个人片数、间隔、最大量、补服或换算；应按手中准确药盒的现行说明书，并在需要时请药师或医生核对。",
          "en": "No. 100 is only the package count in this U.S. label and 500 mg is only ingredient amount per caplet. The page provides no personal count, interval, maximum, catch-up instruction or conversion; use the current label for the exact pack in hand and obtain pharmacist or clinician review when needed."
        }
      },
      {
        "question": {
          "zh": "PANADOL 与 TYLENOL 都写对乙酰氨基酚，能否直接互换或和感冒药一起吃？",
          "en": "If PANADOL and TYLENOL both say acetaminophen, can they be directly substituted or taken with a cold medicine?"
        },
        "answer": {
          "zh": "不能仅凭共同成分或品牌类别自行决定。必须核对实际产品的市场、剂型、每单位含量、是否还有感冒/夜间/复方成分及完整药单；不要自行叠加、轮换、停用或用网页推导片数。",
          "en": "Not from a shared ingredient or brand category alone. Check the actual product's market, dosage form, amount per unit, possible cold/nighttime/combination ingredients and complete medicine list; do not self-combine, alternate, stop or derive a caplet count from a webpage."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "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/panadol-extra-strength/",
    "en": "https://origindrug.com/en/drugs/panadol-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."
  ]
}