{
  "id": "imodium-a-d",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-08-24",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "IMODIUM A-D",
    "generic": "盐酸洛哌丁胺",
    "aliases": [
      "imodium",
      "loperamide",
      "loperamide hydrochloride",
      "盐酸洛哌丁胺"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "消化系统",
    "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 2 mg、12 片〔2 板×6 片〕纸盒，NDC 50580-317-06）",
    "dosageFormClass": "口服薄膜衣片（本档案限定为盐酸洛哌丁胺 2 mg 片）",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）",
    "archiveSponsorText": "DailyMed（NLM）公开标签档案；Kenvue Brands LLC"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "IMODIUM A-D 2 mg Caplets"
    ],
    "excludedProductCues": [
      "IMODIUM Multi-Symptom Relief",
      "loperamide simethicone",
      "IMODIUM oral solution",
      "IMODIUM liquid"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-imodium-a-d-loperamide-hcl-film-coated-tablet-2mg-12ct-ndc-50580-317-06",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 标签 2025-09-23 更新",
        "en": "DailyMed label updated 23 Sep 2025"
      },
      "dosageForm": {
        "zh": "IMODIUM A-D 盐酸洛哌丁胺薄膜衣口服片",
        "en": "IMODIUM A-D loperamide hydrochloride film-coated oral tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 50580-317-06",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸洛哌丁胺 2 mg；12 片（2 板×6 片）纸盒",
        "en": "Loperamide hydrochloride 2 mg per caplet; 12-caplet carton (2 blisters of 6)"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=imodium-01.jpg&setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸洛哌丁胺",
            "en": "loperamide hydrochloride"
          },
          "value": 2,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是个人片数、联用或换药规则",
            "en": "labelled amount per caplet; not an individual's tablet count, combination or switching rule"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister_carton",
        "typeLabel": {
          "zh": "2 板×6 片泡罩装纸盒",
          "en": "carton with 2 blister packs of 6 caplets"
        },
        "fill": null,
        "countPerPackage": 12,
        "countUnit": {
          "zh": "片/纸盒",
          "en": "caplets per carton"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-08-24",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "not_established",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 12,
        "unit": {
          "zh": "片/纸盒",
          "en": "caplets per carton"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "椭圆形薄膜衣片（标签称 capsule-shaped）",
          "en": "oval film-coated caplet (label calls it capsule-shaped)"
        },
        "imprint": "IMO / 2 / MG",
        "scoreStatus": "scored_status_not_a_split_instruction",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_c020c855fd353d39",
        "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_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-imodium-a-d-loperamide-hcl-film-coated-tablet-2mg-12ct-ndc-50580-317-06",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=imodium-01.jpg&setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2&type=img",
    "alt": "IMODIUM A-D 盐酸洛哌丁胺在美国 DailyMed Kenvue 公开标签中的 2 mg、NDC 50580-317-06、12 片（2 板×6 片）纸盒展示面",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 标签（2025-09-23 更新）",
    "presentation": "IMODIUM A-D 盐酸洛哌丁胺薄膜衣口服片：每片 2 mg，NDC 50580-317-06，12 片（2 板×6 片）泡罩装纸盒展示面。",
    "notice": "此图只对应美国 DailyMed 当前标签中的 IMODIUM A-D、盐酸洛哌丁胺 2 mg、NDC 50580-317-06 与 12 片（2 板×6 片）泡罩装纸盒。它只帮助核对品牌、通用名、每片标示量、片剂、包装数量与来源；不用于鉴定真伪，也不证明复方 IMODIUM、液体、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、掰分、联用、开始、停用或换药方案。",
    "source": {
      "id": "src_c020c855fd353d39",
      "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_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": "IMODIUM A-D 说明书放大阅读：2 mg、12 片包装与刻痕须一起核对",
      "en": "IMODIUM A-D label reading: read 2 mg, the 12-caplet pack and the score together"
    },
    "summary": {
      "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 IMODIUM A-D、盐酸洛哌丁胺、每片 2 mg、口服薄膜衣片、12 片（2 板×6 片）包装和目标市场。它不提供个人片数、联用、停用、掰分或换药指令。",
      "en": "This module uses the U.S. DailyMed public label to check IMODIUM A-D, loperamide hydrochloride, 2 mg per caplet, film-coated oral-tablet form, the 12-caplet pack (2 blisters of 6) and target market. It does not provide individual tablet-count, combination, stopping, splitting or switching instructions."
    },
    "checks": [
      {
        "zh": "先将 IMODIUM A-D、盐酸洛哌丁胺、每片 2 mg、口服薄膜衣片、NDC 50580-317-06、12 片（2 板×6 片）纸盒和目标市场一起核对。2 mg 是这一准确片剂的标签标示量，不是网页给任何人计算片数的答案。",
        "en": "Check IMODIUM A-D, loperamide hydrochloride, 2 mg per caplet, film-coated oral-tablet form, NDC 50580-317-06, the 12-caplet carton (2 blisters of 6) and target market together. 2 mg is the labelled strength for this exact caplet, not a web answer to anyone's tablet count."
      },
      {
        "zh": "标签的产品属性记录为白色椭圆片、刻印 IMO / 2 / MG，并显示可分为 2 pieces 的刻痕；这只是外观身份字段，不是“可以自行掰半、减量或按半片换算”的指令。是否可分割、如何使用须以实际产品现行标签和药师或医生核对为准。",
        "en": "The label records a white oval caplet, IMO / 2 / MG imprint and a 2-piece score. These are appearance identity fields, not an instruction to self-split, reduce or convert by half a caplet. Whether and how a product can be split must be checked against the current label for the actual product with a pharmacist or clinician."
      },
      {
        "zh": "该标签警示超量使用可能造成严重心脏问题或死亡；并将黑便/血便、发热、黏液便、肝病、心律异常、其他处方药与症状超过两天或腹部胀大列为需要及时按标签和专业渠道处理的线索。不要用网站把这些线索变成自行加量、继续、停药、联用或替换方案。",
        "en": "The label warns that taking more than directed can cause serious heart problems or death. It also flags black or bloody stool, fever, mucus in stool, liver disease, abnormal heart rhythm, other prescription medicines, symptoms over two days or abdominal swelling as cues for prompt action through the label and professional channels. Do not turn these cues into a self-directed increase, continuation, stopping, combination or substitution plan from a website."
      },
      {
        "zh": "IMODIUM 名称、包装图、颜色或刻印只能帮助定位来源，不能鉴定真伪、证明当前批准或决定个人是否适用。疑似过量、严重腹痛/腹胀、黑便/血便、晕厥、心悸或其他急性不适时，应优先使用当地紧急医疗支持。",
        "en": "The IMODIUM name, package image, colour or imprint can only help locate a source; they cannot authenticate a product, establish current approval or decide individual suitability. With suspected overdose, severe abdominal pain or swelling, black or bloody stool, fainting, palpitations or another acute problem, prioritise local emergency medical support."
      }
    ],
    "source": {
      "id": "src_c020c855fd353d39",
      "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_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": "盐酸洛哌丁胺怎样被标签识别：止泻药类别不等于可自行调整",
      "en": "How the label identifies loperamide hydrochloride: an antidiarrheal class is not a self-adjustment rule"
    },
    "summary": {
      "zh": "美国 DailyMed 标签将 IMODIUM A-D 标为止泻药。这个类别帮助读者找到准确产品、用途和警示；它不决定某个人腹泻的原因、是否适用，或是否能与另一种止泻、止痛、感冒或处方产品一起使用。",
      "en": "The U.S. DailyMed label identifies IMODIUM A-D as an antidiarrheal. This class helps readers locate the exact product, use and warnings; it does not determine why a person has diarrhoea, individual suitability or whether another antidiarrheal, pain, cold or prescription product can be used with it."
    },
    "checks": [
      {
        "zh": "“止泻药”是标签类别线索，不是病因诊断或自我分诊工具。血便、黑便、发热、持续或加重症状等情况需要当地专业渠道判断。",
        "en": "“Antidiarrheal” is a label-class clue, not a cause diagnosis or self-triage tool. Bloody or black stool, fever, persistent or worsening symptoms need assessment through local professional channels."
      },
      {
        "zh": "同一类别、同一商品名或相同 2 mg 数字不表示不同片剂、液体、复方、不同市场包装或另一种止泻产品可以自行叠加、轮换、替代或按半片/毫升换算。",
        "en": "A shared class, brand name or 2 mg number does not make different tablets, liquids, combinations, market packs or another antidiarrheal self-combinable, alternatable, substitutable or convertible by half-caplet or millilitres."
      },
      {
        "zh": "标签对超量风险与并用处方药的提示说明，完整药单和实际包装必须与症状一起核对；它不是网页将任何人划为“安全”或“不安全”的规则。",
        "en": "The label's cues about excess-use risk and other prescription medicines show why the full medicine list and actual pack must be reviewed alongside symptoms; they are not a web rule that sorts anyone into “safe” or “unsafe.”"
      }
    ],
    "source": {
      "id": "src_c020c855fd353d39",
      "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_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": "IMODIUM A-D",
      "generic": "盐酸洛哌丁胺",
      "dosageFormClass": "口服薄膜衣片（本档案限定为盐酸洛哌丁胺 2 mg 片）"
    },
    "labelSource": {
      "id": "src_c020c855fd353d39",
      "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "historical_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_c020c855fd353d39",
          "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_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 的 IMODIUM A-D（loperamide hydrochloride）美国 OTC 公开标签将本档案所列产品标示为每片 2 mg 的口服薄膜衣片。页面帮助阅读品牌、通用名、每片强度、准确包装和美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。",
    "history": "标签中“caplet”、2 mg、泡罩数量和刻痕都属于这一准确产品的身份线索。它们不能变成网页上的个人片数、间隔、拆分、联用、停用或换药规则；名称相近的复方或液体产品需要逐项另核对。",
    "sourceDocuments": [
      {
        "id": "src_c020c855fd353d39",
        "label": "DailyMed（NLM）：IMODIUM A-D 盐酸洛哌丁胺 2 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；2025-09-23 更新）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "historical_public_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      },
      {
        "id": "src_5ed30b676fbb9773",
        "label": "FDA Drugs@FDA 官方检索入口",
        "url": "https://www.accessdata.fda.gov/scripts/cder/daf/",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "official_lookup_entry",
        "documentKind": "regulatory_lookup",
        "market": "US",
        "accessStatus": "public_access_requires_interaction",
        "accessMode": "interactive_lookup",
        "accessVerifiedAt": "2026-08-20",
        "reviewedAt": "2026-08-20"
      }
    ],
    "applicationNumber": "DailyMed U.S. OTC label record",
    "approvalTimeline": [
      {
        "date": "2025-09-23 updated",
        "title": {
          "zh": "DailyMed 公开标签版本",
          "en": "DailyMed public label version"
        },
        "detail": {
          "zh": "本页链接 2025-09-23 updated 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。",
          "en": "This page links the 2025-09-23 updated DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status."
        },
        "source": {
          "id": "src_c020c855fd353d39",
          "label": "DailyMed: IMODIUM A-D loperamide hydrochloride current U.S. OTC label",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=01da76d0-1979-4c45-9d39-c72ae4e4ffe2",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "historical_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 OTC 公开标签",
          "en": "OTC public label linked"
        },
        "detail": {
          "zh": "仅对应本页所列 DailyMed OTC 文件。",
          "en": "Only the DailyMed OTC document listed on this page is linked."
        }
      },
      {
        "market": {
          "zh": "中国大陆、欧盟、日本",
          "en": "Mainland China, EU, Japan"
        },
        "status": {
          "zh": "待逐项建立市场记录",
          "en": "Market record not established"
        },
        "detail": {
          "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。",
          "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "美国 OTC 标签能代表其他市场或个人用法吗？",
          "en": "Does a U.S. OTC label represent another market or personal use?"
        },
        "answer": {
          "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。",
          "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review."
        }
      },
      {
        "question": {
          "zh": "为什么不把 OTC 档案写成原始批准或原研结论？",
          "en": "Why does the OTC archive not state original approval or originator conclusions?"
        },
        "answer": {
          "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。",
          "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "how-to-read-a-drug-label",
      "regulatory-sources-first"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/imodium-a-d/",
    "en": "https://origindrug.com/en/drugs/imodium-a-d/"
  },
  "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."
  ]
}