{
  "id": "aggrenox-aspirin-dipyridamole",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-06",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "AGGRENOX",
    "generic": "阿司匹林／缓释双嘧达莫",
    "aliases": [
      "Aggrenox",
      "aspirin and extended-release dipyridamole",
      "aspirin/dipyridamole",
      "aspirin dipyridamole",
      "阿司匹林双嘧达莫",
      "阿司匹林/缓释双嘧达莫",
      "阿司匹林双嘧达莫缓释胶囊",
      "双嘧达莫阿司匹林"
    ],
    "marketBrandNames": [],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "抗凝与血液",
    "sourceArchiveMarket": "美国：AGGRENOX NDA 020884 的历史原品牌身份、RLD 与 DISCN 状态；一个准确历史分装商标签图；当前通用药标签用于安全阅读与包装比较。原品牌当前无准确公开包装主图，不用通用药或分装商图片冒充原厂当前包装。中国大陆、欧盟、日本及其他市场待逐项建立现行记录。",
    "dosageFormClass": "每粒复方胶囊同时装有阿司匹林 25 mg 普通释放小片和双嘧达莫 200 mg 缓释微丸。25 与 200 分属两种成分，不是 225 mg 的单一药物；整粒吞服，不得咀嚼或压碎。",
    "dosageFormClassCode": "oral_modified_release",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "1999（美国初始批准）",
    "archiveSponsorText": "Boehringer Ingelheim Pharmaceuticals, Inc.（美国历史 NDA 持有人）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "AGGRENOX",
      "AGGRENOX 25 mg/200 mg",
      "aspirin and extended-release dipyridamole capsules",
      "阿司匹林双嘧达莫缓释胶囊"
    ],
    "excludedProductCues": [
      "aspirin alone",
      "单方阿司匹林",
      "dipyridamole immediate-release tablets",
      "普通双嘧达莫片",
      "PERSANTINE",
      "clopidogrel",
      "PLAVIX",
      "warfarin",
      "COUMADIN"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-historical-aggrenox-aspirin-25mg-dipyridamole-er-200mg-60-capsule-ndc-0597000160",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 美国历史原品牌标签（2016-08-06 生效）",
        "en": "Historical U.S. DailyMed originator-brand label (effective 6 Aug 2016)"
      },
      "dosageForm": {
        "zh": "AGGRENOX 阿司匹林／缓释双嘧达莫复方胶囊",
        "en": "AGGRENOX aspirin/extended-release dipyridamole combination capsule"
      },
      "route": {
        "zh": "口服；历史原品牌产品身份字段",
        "en": "oral; historical originator-brand product-identity field"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0597-0001-60 / NDA 020884",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒含阿司匹林 25 mg（普通释放）＋双嘧达莫 200 mg（缓释）；60 粒瓶装；不是 225 mg 的单一成分",
        "en": "Each capsule contains aspirin 25 mg (immediate release) plus dipyridamole 200 mg (extended release); 60-count bottle; not one 225 mg ingredient"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "阿司匹林（普通释放糖衣片）",
            "en": "aspirin (immediate-release sugar-coated tablet)"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率",
            "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "双嘧达莫（缓释微丸）",
            "en": "dipyridamole (extended-release pellets)"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法",
            "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "单位使用瓶装",
          "en": "unit-of-use bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": false,
        "ndcDirectoryListed": false,
        "marketAvailability": "historical_discontinued_rld",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "红色帽、象牙色体；内含黄色缓释微丸和一枚白色普通释放阿司匹林圆片",
          "en": "red cap and ivory body; contains yellow extended-release pellets and one round white immediate-release aspirin tablet"
        },
        "shape": {
          "zh": "硬明胶胶囊；必须整粒吞服，不得咀嚼或压碎",
          "en": "hard-gelatin capsule; swallow whole and do not chew or crush"
        },
        "imprint": "Boehringer Ingelheim logo;01A",
        "scoreStatus": "capsule_not_a_split_tablet",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_bb227df91a373b15",
        "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_historical_record",
        "documentKind": "historical_product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-historical-repackaged-aggrenox-25mg-200mg-60-capsule-ndc-5486851430",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 2012 历史分装商标签；源产品 NDC 0597-0001",
        "en": "Historical 2012 DailyMed repackager label; source product NDC 0597-0001"
      },
      "dosageForm": {
        "zh": "AGGRENOX 阿司匹林／缓释双嘧达莫复方胶囊",
        "en": "AGGRENOX aspirin/extended-release dipyridamole combination capsule"
      },
      "route": {
        "zh": "口服；历史分装商包装身份字段",
        "en": "oral; historical repackager pack-identity field"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 54868-5143-0 (source NDC 0597-0001)",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒阿司匹林 25 mg＋缓释双嘧达莫 200 mg；60 粒历史分装包装；图片是分装商标签，不是原厂纸盒或当前库存",
        "en": "Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; historical 60-count repackaged pack; image is a repackager label, not the originator carton or current stock"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=5143.jpg&setid=e729d829-4bd0-4074-85ea-e0f9f5d7cdb5&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "阿司匹林（普通释放糖衣片）",
            "en": "aspirin (immediate-release sugar-coated tablet)"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率",
            "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "双嘧达莫（缓释微丸）",
            "en": "dipyridamole (extended-release pellets)"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法",
            "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "单位使用瓶装",
          "en": "unit-of-use bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": false,
        "ndcDirectoryListed": false,
        "marketAvailability": "historical_repackaged_brand_source_product",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "红色帽、象牙色体；内含黄色缓释微丸和一枚白色普通释放阿司匹林圆片",
          "en": "red cap and ivory body; contains yellow extended-release pellets and one round white immediate-release aspirin tablet"
        },
        "shape": {
          "zh": "硬明胶胶囊；必须整粒吞服，不得咀嚼或压碎",
          "en": "hard-gelatin capsule; swallow whole and do not chew or crush"
        },
        "imprint": "Boehringer Ingelheim logo;01A",
        "scoreStatus": "capsule_not_a_split_tablet",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_687733cfe5f4baeb",
        "label": "DailyMed（NLM）：AGGRENOX 25 mg／200 mg、60 粒历史分装商包装标签（Physicians Total Care；源 NDC 0597-0001）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e729d829-4bd0-4074-85ea-e0f9f5d7cdb5",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_historical_record",
        "documentKind": "historical_repackaged_product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-current-generic-aspirin-25mg-dipyridamole-er-200mg-30-capsule-ndc-6846240530",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国通用药标签（2025-09 修订）",
        "en": "Current U.S. DailyMed generic label (revised Sep 2025)"
      },
      "dosageForm": {
        "zh": "阿司匹林 25 mg／缓释双嘧达莫 200 mg 复方胶囊",
        "en": "aspirin 25 mg/extended-release dipyridamole 200 mg combination capsule"
      },
      "route": {
        "zh": "口服；当前通用药比较项",
        "en": "oral; current generic comparator"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 68462-405-30",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒阿司匹林 25 mg＋缓释双嘧达莫 200 mg；30 粒瓶装；这是当前通用药比较项，不是 AGGRENOX 原品牌包装",
        "en": "Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; 30-count bottle; this is a current generic comparator, not an AGGRENOX originator-brand pack"
      },
      "imageUrl": null,
      "visualStatus": "source_text_only_no_exact_public_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "阿司匹林（普通释放糖衣片）",
            "en": "aspirin (immediate-release sugar-coated tablet)"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率",
            "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "双嘧达莫（缓释微丸）",
            "en": "dipyridamole (extended-release pellets)"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法",
            "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 30,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_generic_label_record",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 30,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "红棕色不透明帽、乳白色不透明体",
          "en": "reddish-brown opaque cap and cream opaque body"
        },
        "shape": {
          "zh": "0el 号硬明胶胶囊；内含淡黄至黄色缓释微丸和白至类白色普通释放小片",
          "en": "size 0el hard-gelatin capsule; contains light-yellow to yellow extended-release pellets and a white to off-white immediate-release tablet"
        },
        "imprint": "G;405",
        "scoreStatus": "capsule_not_a_split_tablet",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_50f4b5ef025b301b",
        "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-current-generic-aspirin-25mg-dipyridamole-er-200mg-60-capsule-ndc-6846240560",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国通用药标签（2025-09 修订）",
        "en": "Current U.S. DailyMed generic label (revised Sep 2025)"
      },
      "dosageForm": {
        "zh": "阿司匹林 25 mg／缓释双嘧达莫 200 mg 复方胶囊",
        "en": "aspirin 25 mg/extended-release dipyridamole 200 mg combination capsule"
      },
      "route": {
        "zh": "口服；当前通用药比较项",
        "en": "oral; current generic comparator"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 68462-405-60",
      "pouchCode": null,
      "applicationNumber": null,
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_capsule",
      "primaryDisplay": {
        "zh": "每粒阿司匹林 25 mg＋缓释双嘧达莫 200 mg；60 粒瓶装；这是当前通用药比较项，不是 AGGRENOX 原品牌包装",
        "en": "Aspirin 25 mg plus extended-release dipyridamole 200 mg per capsule; 60-count bottle; this is a current generic comparator, not an AGGRENOX originator-brand pack"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=LBL25mg-200mg60s.jpg&setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "阿司匹林（普通释放糖衣片）",
            "en": "aspirin (immediate-release sugar-coated tablet)"
          },
          "value": 25,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的阿司匹林标示量；不是个人粒数或频率",
            "en": "labelled aspirin amount in each combination capsule; not an individual's capsule count or frequency"
          }
        },
        {
          "ingredient": {
            "zh": "双嘧达莫（缓释微丸）",
            "en": "dipyridamole (extended-release pellets)"
          },
          "value": 200,
          "unit": "mg",
          "basisCode": "per_capsule",
          "basisLabel": {
            "zh": "每粒复方胶囊中的缓释双嘧达莫标示量；不是另一粒药或个人用法",
            "en": "labelled extended-release dipyridamole amount in each combination capsule; not a second medicine unit or an individual's regimen"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 60,
        "countUnit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-06",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_generic_label_record",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 60,
        "unit": {
          "zh": "粒/瓶",
          "en": "capsules per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "红棕色不透明帽、乳白色不透明体",
          "en": "reddish-brown opaque cap and cream opaque body"
        },
        "shape": {
          "zh": "0el 号硬明胶胶囊；内含淡黄至黄色缓释微丸和白至类白色普通释放小片",
          "en": "size 0el hard-gelatin capsule; contains light-yellow to yellow extended-release pellets and a white to off-white immediate-release tablet"
        },
        "imprint": "G;405",
        "scoreStatus": "capsule_not_a_split_tablet",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_50f4b5ef025b301b",
        "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "status": "withheld_repackaged_or_non_exact_visual",
    "title": {
      "zh": "没有原厂当前包装图时，明确留白，不用相似胶囊代替",
      "en": "When no current originator-pack image is available, leave it explicit rather than substitute a similar capsule"
    },
    "summary": {
      "zh": "历史原品牌标签描述红帽、象牙色体、BI 标志与 01A；当前通用药则是 G／405。两者只能按各自准确身份阅读。历史分装商图只保留在对应分装记录里，不进入原品牌主图位；颜色、形状、微丸或一张分装标签都不能单独证明真伪，也不用于鉴定真伪。",
      "en": "The historical originator label describes a red cap, ivory body, BI logo and 01A; the current generic is G/405. Each belongs only to its exact identity. The historical repackager image remains only in its matching repackager record and is not used as the originator hero visual; colour, shape, pellets or one label cannot establish authenticity."
    },
    "source": {
      "id": "src_bb227df91a373b15",
      "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_historical_record",
      "documentKind": "historical_product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-06",
      "reviewedAt": "2026-09-06"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "AGGRENOX 说明书放大阅读：一粒两种成分，先查重复，再看出血警报",
      "en": "AGGRENOX enlarged label: two ingredients in one capsule—check duplication before bleeding alarms"
    },
    "summary": {
      "zh": "25 mg 是每粒中的阿司匹林，200 mg 是同一粒中的缓释双嘧达莫；不是两粒，也不是可拆开的配方。网页帮助识别成分、包装数字、完整吞服与警戒信号，不生成个人粒数、停换药或漏服方案。",
      "en": "25 mg is the aspirin in each capsule and 200 mg is extended-release dipyridamole in that same capsule. They are not two capsules or a formulation to dismantle. The page supports ingredient, pack-number, whole-capsule and warning-signal literacy, not individual capsule counts, stopping/switching or missed-use plans."
    },
    "checks": [
      {
        "zh": "胶囊必须整粒吞服，不得咀嚼或压碎。它不能用单方阿司匹林片和普通双嘧达莫片按毫克自行拼成，也不能把胶囊打开后分微丸、丢掉白色小片或只吃其中一部分。吞咽困难应请药师核对准确替代产品。",
        "en": "Swallow the capsule whole; do not chew or crush it. Do not self-assemble it from aspirin tablets and immediate-release dipyridamole, open it to divide pellets, discard the white tablet or take only part. Dysphagia requires pharmacist review of an exact alternative product."
      },
      {
        "zh": "这粒复方已经含阿司匹林。处方药、非处方止痛药、感冒药和保健品都应按有效成分核对；另见阿司匹林、抗凝药、其他抗血小板药、肝素、溶栓药、阿那格雷或长期 NSAID 时，不要自行叠加或靠错开时间消除风险。",
        "en": "This combination already contains aspirin. Check active ingredients across prescriptions, OTC pain/cold products and supplements. If another aspirin, anticoagulant, antiplatelet, heparin, fibrinolytic, anagrelide or chronically used NSAID appears, do not self-combine it or assume timing separation removes risk."
      },
      {
        "zh": "呕血或咖啡渣样呕吐、黑便或血便、持续或无法控制的出血、严重头痛伴嗜睡/意识或记忆改变、昏厥，以及新的或加重的胸痛，应及时使用当地医疗服务；严重急性表现使用急救。",
        "en": "Vomiting blood or coffee-ground material, black or bloody stool, persistent or uncontrolled bleeding, severe headache with drowsiness, awareness or memory change, loss of consciousness, or new/worsening chest pain requires prompt local medical care; severe acute features require emergency help."
      },
      {
        "zh": "开始后头痛并不少见，但网页不能把说明书里的专业替代方案变成自行改服法。严重或难以耐受的头痛、计划药物负荷试验、手术/拔牙、活动性消化性溃疡、肾肝问题、低血压、重症肌无力、怀孕或大量饮酒均应主动告知负责团队。",
        "en": "Headache is not uncommon after initiation, but the site must not turn the label's clinician-directed alternative into self-adjustment. Severe or intolerable headache, planned pharmacologic stress testing, surgery/dental work, active peptic ulcer, kidney/liver problems, low blood pressure, myasthenia gravis, pregnancy or heavy alcohol use should be disclosed to the responsible team."
      }
    ],
    "source": {
      "id": "src_50f4b5ef025b301b",
      "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-06",
      "reviewedAt": "2026-09-06"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "为什么是两种抗血小板路径：作用相加，不代表可以随意加更多“血液药”",
      "en": "Why two antiplatelet pathways: additive action does not permit adding more ‘blood thinners’"
    },
    "summary": {
      "zh": "标签把抗血栓作用解释为双嘧达莫与阿司匹林抗血小板效应的相加。阿司匹林不可逆抑制血小板环氧化酶、降低血栓烷 A2；双嘧达莫增加腺苷相关信号并抑制 cGMP 磷酸二酯酶。机制解释产品设计，但不能替个人判断是否适合。",
      "en": "The label attributes antithrombotic action to additive antiplatelet effects of dipyridamole and aspirin. Aspirin irreversibly inhibits platelet cyclooxygenase and lowers thromboxane A2; dipyridamole augments adenosine-related signalling and inhibits cGMP phosphodiesterase. Mechanism explains the product design but cannot decide individual suitability."
    },
    "checks": [
      {
        "zh": "AGGRENOX、单方阿司匹林、PLAVIX/氯吡格雷、BRILINTA/替格瑞洛、EFFIENT/普拉格雷、PLETAL/西洛他唑和口服抗凝药机制、剂型和证据边界不同，不能按“防血栓”用途或 mg 自行换算、轮换或叠加。",
        "en": "AGGRENOX, aspirin alone, PLAVIX/clopidogrel, BRILINTA/ticagrelor, EFFIENT/prasugrel, PLETAL/cilostazol and oral anticoagulants differ in mechanism, product form and evidence boundaries. A shared antithrombotic purpose or milligram figure does not permit self-conversion, rotation or combination."
      },
      {
        "zh": "双嘧达莫有血管扩张作用，可能出现头痛、头晕、低血压或胸痛变化。老人出现跌倒、晕厥、明显虚弱或胸痛变化时，要把实际药盒、血压记录与完整药单一起交给医疗团队核对。",
        "en": "Dipyridamole has vasodilatory effects, so headache, dizziness, low blood pressure or altered chest pain may occur. An older adult with a fall, fainting, marked weakness or changed chest pain should have the actual pack, blood-pressure record and complete medicine list reviewed together."
      },
      {
        "zh": "低剂量阿司匹林在这粒复方里的存在，不表示它足以覆盖另一个心脏适应证，也不表示应自行再加阿司匹林。药物选择需由负责团队按具体适应证、出血与血栓风险核对。",
        "en": "The low-dose aspirin inside this combination does not mean it covers another cardiac indication, nor that extra aspirin should be added. The responsible team must review the exact indication and both bleeding and thrombotic risks."
      }
    ],
    "source": {
      "id": "src_bb227df91a373b15",
      "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "dated_historical_record",
      "documentKind": "historical_product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-06",
      "reviewedAt": "2026-09-06"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "AGGRENOX",
      "generic": "阿司匹林／缓释双嘧达莫",
      "dosageFormClass": "每粒复方胶囊同时装有阿司匹林 25 mg 普通释放小片和双嘧达莫 200 mg 缓释微丸。25 与 200 分属两种成分，不是 225 mg 的单一药物；整粒吞服，不得咀嚼或压碎。"
    },
    "labelSource": {
      "id": "src_50f4b5ef025b301b",
      "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-06",
      "reviewedAt": "2026-09-06"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_50f4b5ef025b301b",
          "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-06",
          "reviewedAt": "2026-09-06"
        },
        "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": "2026-09-06",
        "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."
        }
      },
      {
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        },
        "status": "product_level_public_record_verified",
        "authority": {
          "zh": "FDA",
          "en": "FDA"
        },
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "recordType": {
          "zh": "监管产品记录或标签档案",
          "en": "Regulatory product record or label archive"
        },
        "reviewedAt": "2026-08-29",
        "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": "2026-09-06",
      "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": "AGGRENOX 是把低剂量阿司匹林和缓释双嘧达莫装在同一粒胶囊内的历史美国原品牌。老人整理药盒时最容易漏看的是“这粒药已经含阿司匹林”：若药单另有阿司匹林、氯吡格雷、替格瑞洛、华法林、阿哌沙班、利伐沙班、肝素或布洛芬/萘普生等 NSAID，应先让药师或临床医生核对出血风险，不要自行叠加、错开、停用或替换。",
    "history": "FDA 于 1999-11-22 批准 NDA 020884。原始医学审评记录了 Asasantine／AGGRENOX 国际开发和 ESPS2 证据。DailyMed 保留原品牌历史标签与多个历史分装商标签；当前 Orange Book 行为 DISCN，而当前通用药标签仍在更新，因此本页把历史原品牌、分装包装与当前通用药严格分开。",
    "sourceDocuments": [
      {
        "id": "src_bb227df91a373b15",
        "label": "DailyMed（NLM）：AGGRENOX 阿司匹林 25 mg／缓释双嘧达莫 200 mg 美国历史原品牌标签（2016-08-06 生效）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=f07c8535-f9fb-4697-9b63-1ab22210efc9",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_historical_record",
        "documentKind": "historical_product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_687733cfe5f4baeb",
        "label": "DailyMed（NLM）：AGGRENOX 25 mg／200 mg、60 粒历史分装商包装标签（Physicians Total Care；源 NDC 0597-0001）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e729d829-4bd0-4074-85ea-e0f9f5d7cdb5",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_historical_record",
        "documentKind": "historical_repackaged_product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_50f4b5ef025b301b",
        "label": "DailyMed（NLM）：阿司匹林 25 mg／缓释双嘧达莫 200 mg 胶囊当前美国通用药标签（2025-09 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=467d6ce3-bc05-4aa1-87cc-3214fd628d39",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_183570ab7b9ff3af",
        "label": "FDA：AGGRENOX NDA 020884 最初批准标签（1999）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_aggrenox_prntlbl.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_historical_record",
        "documentKind": "historical_product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_31e6352e78acfb22",
        "label": "FDA：AGGRENOX NDA 020884 原始医学审评（ESPS2 与国际开发史）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_medr_P2.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_historical_record",
        "documentKind": "regulatory_review",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-06",
        "reviewedAt": "2026-09-06"
      },
      {
        "id": "src_10e511bf83430e3b",
        "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录",
        "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_dataset",
        "documentKind": "regulatory_product_record",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-08-29",
        "reviewedAt": "2026-08-29"
      }
    ],
    "applicationNumber": "FDA NDA 020884（AGGRENOX aspirin 25 mg / extended-release dipyridamole 200 mg capsules）",
    "approvalTimeline": [
      {
        "date": "1999-11-22",
        "title": {
          "zh": "FDA 初始批准 AGGRENOX",
          "en": "FDA initially approved AGGRENOX"
        },
        "detail": {
          "zh": "Orange Book 将 NDA 020884 产品 001 的批准日列为 1999-11-22；最初标签列 Initial U.S. Approval: 1999。",
          "en": "The Orange Book lists 22 Nov 1999 for Product 001 under NDA 020884, and the original label states Initial U.S. Approval: 1999."
        },
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      },
      {
        "date": "1999",
        "title": {
          "zh": "原始医学审评记录固定复方与 ESPS2",
          "en": "Original medical review records the fixed combination and ESPS2"
        },
        "detail": {
          "zh": "FDA 医学审评把双嘧达莫缓释与普通释放阿司匹林固定复方、国际 Asasantine 开发和 ESPS2 试验背景相连；历史证据不能直接代表今日个体获益。",
          "en": "FDA's medical review links the fixed extended-release dipyridamole/immediate-release aspirin combination to international Asasantine development and ESPS2. Historical evidence cannot itself establish an individual's present benefit."
        },
        "source": {
          "id": "src_31e6352e78acfb22",
          "label": "FDA：AGGRENOX NDA 020884 原始医学审评（ESPS2 与国际开发史）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/99/20884_AGGRENOX_medr_P2.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_historical_record",
          "documentKind": "regulatory_review",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-06",
          "reviewedAt": "2026-09-06"
        }
      },
      {
        "date": "2026-09-06",
        "title": {
          "zh": "当前橙皮书核对为历史 RLD／DISCN",
          "en": "Current Orange Book review: historical RLD/DISCN"
        },
        "detail": {
          "zh": "产品 001 为 RLD、非 RS、状态 DISCN，并带有并非因安全性或有效性撤市的联邦公报判定。",
          "en": "Product 001 is an RLD, not the RS, and is DISCN, with a Federal Register determination that it was not discontinued or withdrawn for safety or effectiveness reasons."
        },
        "source": {
          "id": "src_10e511bf83430e3b",
          "label": "FDA Orange Book：AGGRENOX NDA 020884 美国历史 RLD／DISCN 记录",
          "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_dataset",
          "documentKind": "regulatory_product_record",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-08-29",
          "reviewedAt": "2026-08-29"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国",
          "en": "United States"
        },
        "status": {
          "zh": "原品牌历史 RLD 已停止销售；当前通用药标签存在",
          "en": "Historical originator RLD discontinued; current generic labels exist"
        },
        "detail": {
          "zh": "本页展示原品牌历史身份、一个历史分装商标签图和当前通用药比较项；它们不表示 AGGRENOX 原品牌当前有货。",
          "en": "The page shows historical originator identity, one historical repackager label and current generic comparators. None establishes current AGGRENOX originator stock."
        }
      },
      {
        "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": "待逐项建立现行市场记录",
          "en": "Current market record not established"
        },
        "detail": {
          "zh": "不从美国 NDA、Asasantine 名称或共同成分推定当地批准、商品名、供应、医保、原研/仿制关系或可替代性。",
          "en": "No local approval, brand, supply, reimbursement, originator/generic relationship or interchangeability is inferred from the U.S. NDA, Asasantine name or shared ingredients."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "这粒药已经含阿司匹林，我还能再吃阿司匹林或止痛药吗？",
          "en": "This capsule already contains aspirin. Can I add aspirin or a pain medicine?"
        },
        "answer": {
          "zh": "不要自行添加。先把处方药、非处方止痛/感冒药和保健品的全部有效成分交给药师或临床医生核对；另一份阿司匹林、NSAID、抗血小板药或抗凝药可能改变出血风险。",
          "en": "Do not add one yourself. Have a pharmacist or clinician review every active ingredient across prescriptions, OTC pain/cold products and supplements; another aspirin, NSAID, antiplatelet or anticoagulant can change bleeding risk."
        }
      },
      {
        "question": {
          "zh": "25 mg 加 200 mg，是不是一粒 225 mg 的药？",
          "en": "Does 25 mg plus 200 mg make one 225 mg medicine?"
        },
        "answer": {
          "zh": "不是。25 mg 属于阿司匹林普通释放小片，200 mg 属于双嘧达莫缓释微丸；两种成分、两种释放设计必须分别理解，不能相加后与任何 225 mg 产品比较或换算。",
          "en": "No. The 25 mg belongs to the immediate-release aspirin tablet and the 200 mg to extended-release dipyridamole pellets. They are separate ingredients and release designs and must not be summed for comparison or conversion to any 225 mg product."
        }
      },
      {
        "question": {
          "zh": "胶囊可以打开，把里面分一半吗？",
          "en": "Can the capsule be opened and half the contents used?"
        },
        "answer": {
          "zh": "不可以。标签要求整粒吞服，不得咀嚼或压碎；胶囊内还有两种不同形态的成分，目测分一半不能保证成分比例或释放特征。吞咽困难应让药师核对准确替代产品。",
          "en": "No. The label requires swallowing whole and not chewing or crushing. The capsule also contains two ingredients in different physical forms, so visual halving cannot preserve ingredient ratio or release. Ask a pharmacist to review an exact alternative for swallowing difficulty."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dosage-forms-are-part-of-medicine-identity",
      "how-to-read-a-drug-label",
      "how-to-review-a-family-medicine-list",
      "medicine-safety-and-pharmacovigilance"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/aggrenox-aspirin-dipyridamole/",
    "en": "https://origindrug.com/en/drugs/aggrenox-aspirin-dipyridamole/"
  },
  "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."
  ]
}