{
  "id": "pepcid-famotidine",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-21",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "Pepcid AC Original Strength",
    "generic": "法莫替丁",
    "aliases": [
      "PEPCID AC ORIGINAL STRENGTH",
      "Pepcid AC Original Strength",
      "famotidine"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "消化系统",
    "sourceArchiveMarket": "美国当前 PEPCID AC Original Strength 法莫替丁非处方公开标签（DailyMed SPL v20；2026-02-06 更新，2026-02-11 发布）",
    "dosageFormClass": "法莫替丁口服薄膜衣片（非处方）：每片 10 mg；本档案精确展示 NDC 16837-872-20、30 片纸盒（3 板 × 10 片）",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "美国当前公开标签记录（DailyMed SPL v20）",
    "archiveSponsorText": "Kenvue Brands LLC / DailyMed（NLM）当前公开 OTC 标签档案"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "Pepcid AC Original Strength"
    ],
    "excludedProductCues": [
      "PEPCID COMPLETE",
      "calcium carbonate",
      "magnesium hydroxide",
      "PEPCID AC MAXIMUM STRENGTH",
      "Maximum Strength Pepcid",
      "famotidine 20 mg",
      "Pepcid 20 mg",
      "ICY COOL MINT",
      "compare to Pepcid",
      "repackaged"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-pepcid-ac-original-strength-famotidine-10mg-ndc-16837-872-20",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed SPL v20；2026-02-06 更新，2026-02-11 发布",
        "en": "DailyMed SPL v20; updated 6 Feb 2026 and published 11 Feb 2026"
      },
      "dosageForm": {
        "zh": "法莫替丁口服薄膜衣片（非处方）",
        "en": "famotidine film-coated oral tablet (OTC)"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 16837-872-20",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片法莫替丁 10 mg；30 片纸盒（3 板 × 10 片）",
        "en": "Famotidine 10 mg per tablet; 30-tablet carton (3 blisters × 10 tablets)"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256&name=pepcid-01.jpg",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "法莫替丁",
            "en": "famotidine"
          },
          "value": 10,
          "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": "blister_carton",
        "typeLabel": {
          "zh": "30 片纸盒（3 板 × 10 片）",
          "en": "30-tablet carton (3 blisters × 10 tablets)"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "片/盒",
          "en": "tablets per carton"
        },
        "unitsPerContainer": {
          "count": 10,
          "unit": {
            "zh": "片/泡罩板",
            "en": "tablets per blister"
          }
        }
      },
      "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": 30,
        "unit": {
          "zh": "片/盒",
          "en": "tablets per carton"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色药片（包装面板所示）",
          "en": "white tablet (as shown on the package panel)"
        },
        "shape": {
          "zh": "包装面板未建立精确片形结论",
          "en": "exact tablet shape not established by this package panel"
        },
        "imprint": "not established from this package panel",
        "scoreStatus": "unscored",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_7896e214ce263808",
        "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "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-pepcid-ac-original-strength-famotidine-10mg-ndc-16837-872-20",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256&name=pepcid-01.jpg",
    "alt": "PEPCID AC Original Strength 在美国 DailyMed 当前标签中的法莫替丁 10 mg、NDC 16837-872-20、30 片纸盒包装展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed SPL v20（2026-02-06 更新；2026-02-11 发布）",
    "presentation": "PEPCID AC Original Strength：法莫替丁每片 10 mg；NDC 16837-872-20；30 片纸盒（3 板 × 10 片）包装展示面。",
    "notice": "此图只对应美国当前 SPL v20 中 PEPCID AC Original Strength、法莫替丁每片 10 mg、NDC 16837-872-20 与 30 片纸盒（3 板 × 10 片）。它不用于鉴定真伪，也不代表 PEPCID AC Maximum Strength 20 mg、PEPCID Complete 复方、其他包装、其他市场、实际可得性或任何个人的片数、间隔、开始、停用、联用或替代方案。",
    "source": {
      "id": "src_7896e214ce263808",
      "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "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": "PEPCID AC Original Strength 说明书放大阅读：10 mg 是每片标签量，30 片是包装身份",
      "en": "PEPCID AC Original Strength label reading: 10 mg is the labelled amount per tablet and 30 tablets identify the package"
    },
    "summary": {
      "zh": "本模块只阅读当前美国公开标签中的 PEPCID AC Original Strength、法莫替丁 10 mg、NDC 16837-872-20 与 30 片纸盒。它不提供个人片数、间隔、疗程、漏用处理、与其他胃药合用或换用方案。",
      "en": "This module reads only PEPCID AC Original Strength, famotidine 10 mg, NDC 16837-872-20 and the 30-tablet carton in the current U.S. public label. It provides no individual tablet count, interval, course, missed-use handling, co-use with another stomach medicine or switching plan."
    },
    "checks": [
      {
        "zh": "先把完整商品名、法莫替丁、每片 10 mg、NDC 16837-872-20、30 片纸盒（3 板 × 10 片）、口服薄膜衣片与目标市场一起核对。只看到“Pepcid”“法莫替丁”或“30 片”不能证明另一种强度、包装或市场产品相同。",
        "en": "Check the complete brand name, famotidine, 10 mg per tablet, NDC 16837-872-20, the 30-tablet carton (3 blisters × 10 tablets), film-coated oral tablet and target market together. Seeing only “Pepcid”, “famotidine” or “30 tablets” does not prove another strength, package or market product is the same."
      },
      {
        "zh": "10 mg 是这一个标签片剂中每片的成分量；30 片和每板 10 片只描述包装。它们不是个人一次应服几片、每天几次、连续多久、漏用后如何补用或是否应加倍的规则。",
        "en": "10 mg is the ingredient amount in each tablet of this labelled product; 30 tablets and 10 tablets per blister only describe the package. They are not rules for how many tablets a person should use at once, how often, for how long, how to make up a missed use or whether to double."
      },
      {
        "zh": "PEPCID AC Maximum Strength 20 mg 与本页 10 mg 不是同一强度；PEPCID Complete 还含碳酸钙和氢氧化镁，是复方产品。共同品牌、相近用途或都写“缓解胃灼热”都不能建立自行换用、叠加或轮换关系。",
        "en": "PEPCID AC Maximum Strength 20 mg is not this 10 mg strength; PEPCID Complete also contains calcium carbonate and magnesium hydroxide and is a combination product. A shared brand, similar use or heartburn wording does not establish self-switching, combining or alternating."
      },
      {
        "zh": "若正在同时使用处方药、非处方药、补充剂或其他抑酸/胃肠产品，应带上全部实际药盒和完整药单请药师或医生核对。吞咽困难、呕血、黑便、不明原因体重下降、胸痛或其他急性/严重担忧，应优先使用当地医疗支持；网页不判断是否自行开始、继续、停用或改用。",
        "en": "When using prescription medicines, OTC products, supplements or another acid-reducing/gastrointestinal product, take every actual pack and the complete medicine list to a pharmacist or clinician for review. Difficulty swallowing, vomiting blood, black stools, unexplained weight loss, chest pain or another acute/serious concern requires local medical support first; this page does not decide self-starting, continuing, stopping or changing."
      }
    ],
    "source": {
      "id": "src_7896e214ce263808",
      "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "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": "法莫替丁怎样起作用：它阻断组胺 H2 受体相关的胃酸分泌路径",
      "en": "How famotidine works: it blocks a histamine H2 receptor pathway related to gastric-acid secretion"
    },
    "summary": {
      "zh": "当前公开标签将法莫替丁归为 H2 阻滞剂，并描述其通过竞争性抑制组胺在胃细胞 H2 受体上的作用而抑制胃酸分泌。这个机制帮助阅读药物类别与同类产品边界；不预测个人症状原因、疗效、适用性、片数、间隔或是否可与其他胃药联用。",
      "en": "The current public label classifies famotidine as an H2 blocker and describes competitive inhibition of histamine action at gastric-cell H2 receptors, reducing gastric-acid secretion. This mechanism helps read the medicine class and family boundaries; it does not predict an individual's symptom cause, response, suitability, tablet count, interval or co-use with another stomach medicine."
    },
    "checks": [
      {
        "zh": "“H2 阻滞剂”“减少胃酸分泌”是类别与作用路径说明，不是从烧心、胃痛、夜间不适或一张药盒照片判断病因、风险或个人是否适合用药的工具。",
        "en": "“H2 blocker” and “reduces gastric-acid secretion” describe class and pathway; they are not tools for determining the cause, risk or individual suitability from heartburn, stomach pain, night-time discomfort or one package photograph."
      },
      {
        "zh": "同样涉及胃酸或消化不适的产品可能是不同成分、强度、剂型或复方。机制词不能证明 PEPCID Complete、20 mg 产品、其他抑酸药或其他市场包装可以自行叠加、轮换或替代。",
        "en": "Products involving gastric acid or digestive discomfort may have different ingredients, strengths, forms or combinations. A mechanism word does not prove that PEPCID Complete, a 20 mg product, another acid reducer or another-market package can be self-combined, alternated or substituted."
      },
      {
        "zh": "机制说明不能处理持续或加重症状、吞咽困难、出血相关迹象、胸痛、复杂多药联用或其他急性问题。此类情况应优先使用当地医疗与药师/医生支持，而不是从网页推导处理方案。",
        "en": "A mechanism explanation cannot manage persistent or worsening symptoms, swallowing difficulty, bleeding-related signs, chest pain, complex polypharmacy or another acute concern. Use local medical and pharmacist/clinician support first rather than deriving a plan from a webpage."
      }
    ],
    "source": {
      "id": "src_7896e214ce263808",
      "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "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": "Pepcid AC Original Strength",
      "generic": "法莫替丁",
      "dosageFormClass": "法莫替丁口服薄膜衣片（非处方）：每片 10 mg；本档案精确展示 NDC 16837-872-20、30 片纸盒（3 板 × 10 片）"
    },
    "labelSource": {
      "id": "src_7896e214ce263808",
      "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_public_record",
      "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_7896e214ce263808",
          "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "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 SPL v20 将本展示对象列为 PEPCID AC Original Strength 法莫替丁 10 mg 薄膜衣片，NDC 16837-872-20：30 片纸盒（3 板 × 10 片）。10 mg 是每片标签含量，30 片是包装身份，不是个人片数、间隔、疗程或补用规则。本页帮助核对准确产品、成分、包装和来源；不生成个人用药方案。",
    "history": "本档案只绑定 2026-02-06 更新、2026-02-11 发布的 DailyMed SPL v20 中 NDC 16837-872-20 的 Original Strength 10 mg、30 片包装面板。PEPCID AC Maximum Strength 20 mg 与 PEPCID Complete 的复方成分和包装均需按各自现行标签另行核对。",
    "sourceDocuments": [
      {
        "id": "src_7896e214ce263808",
        "label": "DailyMed（NLM）：PEPCID AC Original Strength 法莫替丁当前美国公开标签（Kenvue；SPL v20）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      }
    ],
    "applicationNumber": "DailyMed SPL setid 54f4086f-e443-4e7e-8c7e-94e152e1c256（SPL v20）",
    "approvalTimeline": [
      {
        "date": "2026-02-06",
        "title": {
          "zh": "当前 PEPCID AC Original Strength 标签更新",
          "en": "Current PEPCID AC Original Strength label updated"
        },
        "detail": {
          "zh": "DailyMed 页面将这份美国公开标签的 Updated 日期列为 2026-02-06。本页只用该标签核对 Original Strength 10 mg、NDC 16837-872-20 与 30 片纸盒；不从标签日期推定实际在售、库存、购买或个人使用安排。",
          "en": "DailyMed lists 6 Feb 2026 as the Updated date for this U.S. public label. This page uses it only to check Original Strength 10 mg, NDC 16837-872-20 and the 30-tablet carton; the date does not establish actual marketing, stock, purchase or an individual's use plan."
        },
        "source": {
          "id": "src_7896e214ce263808",
          "label": "DailyMed: current PEPCID AC Original Strength famotidine public label, SPL v20",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-20",
          "reviewedAt": "2026-08-20"
        }
      },
      {
        "date": "2026-02-11",
        "title": {
          "zh": "DailyMed 发布 SPL v20",
          "en": "DailyMed published SPL v20"
        },
        "detail": {
          "zh": "DailyMed 服务记录将该标签列为 SPL v20，并标示发布日期为 2026-02-11。发布时间与包装、个人片数、间隔、疗程、联用或替代结论无关。",
          "en": "The DailyMed service record lists this label as SPL v20, published 11 Feb 2026. A publication date does not determine package equivalence, individual tablet count, interval, course, co-use or substitution."
        },
        "source": {
          "id": "src_7896e214ce263808",
          "label": "DailyMed: current PEPCID AC Original Strength famotidine public label, SPL v20",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=54f4086f-e443-4e7e-8c7e-94e152e1c256",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "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": "已链接当前公开标签与一个精确包装面板",
          "en": "Current public label and one exact package panel linked"
        },
        "detail": {
          "zh": "本页只展示 NDC 16837-872-20 的 Original Strength 法莫替丁 10 mg、30 片纸盒（3 板 × 10 片）。它不建立实际在售、库存、可得性、其他 NDC、Maximum Strength、PEPCID Complete 复方或个人适用性。",
          "en": "This page displays only Original Strength famotidine 10 mg, NDC 16837-872-20, in a 30-tablet carton (3 blisters × 10 tablets). It does not establish actual marketing, stock, availability, another NDC, Maximum Strength, the PEPCID Complete combination or individual suitability."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本及其他市场",
          "en": "Mainland China, EU, Japan 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、NDC、英文品牌或包装图推定当地商品名、批准、供应、可售资格、原研/仿制关系或可替代性；每个市场须按当地现行监管资料单独核对。",
          "en": "No local trade name, approval, supply, sale eligibility, originator/generic relationship or interchangeability is inferred from the U.S. label, NDC, English brand or package image; each market requires separate checking against current local regulatory material."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "包装写 10 mg、30 片或每板 10 片，是否表示可以自行决定一次吃几片或多久吃一次？",
          "en": "Do 10 mg, 30 tablets or 10 tablets per blister on the package mean someone can decide how many to take at once or how often?"
        },
        "answer": {
          "zh": "不是。这些是这个准确美国标签包装的成分和包装身份。页面不提供个人片数、间隔、疗程、漏用处理或加倍建议；应按手上准确标签并向药师或医生核对。",
          "en": "No. These are ingredient and package identities for this exact U.S.-labelled pack. This page provides no individual tablet count, interval, course, missed-use handling or doubling advice; use the exact label in hand and check with a pharmacist or clinician."
        }
      },
      {
        "question": {
          "zh": "PEPCID Complete、Maximum Strength 或其他“胃药”能否按同品牌或相近用途自行换用、叠加或轮换？",
          "en": "Can PEPCID Complete, Maximum Strength or another “stomach medicine” be self-switched, combined or alternated because of a shared brand or similar use?"
        },
        "answer": {
          "zh": "不能。PEPCID Complete 是复方，Maximum Strength 是不同强度；其他胃肠产品还可能有不同成分、剂型和风险边界。请带全部实际药盒、处方药、非处方药和补充剂让药师或医生逐项核对。",
          "en": "No. PEPCID Complete is a combination product and Maximum Strength is a different strength; other gastrointestinal products may also have different ingredients, forms and risk boundaries. Take all actual packs, prescription medicines, OTC products and supplements to a pharmacist or clinician for item-by-item review."
        }
      }
    ],
    "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/pepcid-famotidine/",
    "en": "https://origindrug.com/en/drugs/pepcid-famotidine/"
  },
  "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."
  ]
}