{
  "id": "xyzal-levocetirizine",
  "recordTier": "source_traceable_archive",
  "editorial": {
    "reviewedAt": "2026-09-03",
    "status": "published_traceable_archive"
  },
  "names": {
    "brand": "XYZAL",
    "generic": "盐酸左西替利嗪片与口服溶液",
    "aliases": [
      "Xyzal",
      "Xyzal Allergy 24HR",
      "levocetirizine",
      "levocetirizine dihydrochloride",
      "左西替利嗪",
      "盐酸左西替利嗪",
      "盐酸左西替利嗪片",
      "左旋西替利嗪",
      "XYZAL",
      "NDA 022064",
      "NDA 022157",
      "NDA 209089",
      "0024-5803-90",
      "0024-5804-05",
      "41167-3510-0",
      "41167-3510-1",
      "41167-3511-2"
    ],
    "marketBrandNames": [
      {
        "name": "XYZAL",
        "market": {
          "zh": "美国处方产品",
          "en": "U.S. prescription product"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "NDA 022064/022157；5 mg 片与 0.5 mg/mL 口服液。",
          "en": "NDA 022064/022157; 5 mg tablets and 0.5 mg/mL oral solution."
        },
        "source": {
          "id": "src_a25547ae6383083a",
          "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        }
      },
      {
        "name": "XYZAL ALLERGY 24HR",
        "market": {
          "zh": "美国非处方产品",
          "en": "U.S. nonprescription product"
        },
        "evidenceStatus": "current_regulatory_record",
        "note": {
          "zh": "NDA 209089；5 mg 普通口服片，多种独立包装。",
          "en": "NDA 209089; 5 mg immediate-release oral tablets in distinct packs."
        },
        "source": {
          "id": "src_24d87dd00ec75624",
          "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        }
      }
    ],
    "mainlandChinaTradeNameCue": null
  },
  "identity": {
    "therapeuticArea": "呼吸系统",
    "sourceArchiveMarket": "美国当前公开记录包括处方 XYZAL 5 mg 片与 0.5 mg/mL 口服液，以及 OTC XYZAL ALLERGY 24HR 5 mg 片。处方与 OTC 的适用人群、用法文字、NDC 和包装不同；页面不把美国记录外推为中国或其他市场的批准、法律分类、库存或个人适用性。",
    "dosageFormClass": "普通口服片与口服溶液。5 mg 是每片含量；2.5 mg/5 mL 与 0.5 mg/mL 是同一口服液浓度的两种写法。片剂数字、液体浓度、瓶装/泡罩片数不能相加，也不能自行换成个人片数或毫升数。",
    "dosageFormClassCode": "oral_solid",
    "route": "口服",
    "routeCode": "oral",
    "historicalApprovalEntry": "2007（XYZAL 片 NDA 022064 获批；2017 年 OTC 转换获批）",
    "archiveSponsorText": "UCB（商标/产品历史）；Sanofi/Chattem（当前美国公开标签）"
  },
  "matchPolicy": {
    "contract": "reviewed_name_and_exclusion_cues_v1",
    "exactMatchNames": [
      "XYZAL levocetirizine",
      "XYZAL ALLERGY 24HR",
      "盐酸左西替利嗪片"
    ],
    "excludedProductCues": [
      "ZYRTEC",
      "cetirizine",
      "西替利嗪",
      "BENADRYL",
      "diphenhydramine",
      "氯雷他定",
      "loratadine",
      "ALLEGRA",
      "fexofenadine"
    ],
    "exclusionPrecedence": "before_name_candidate"
  },
  "productPresentations": [
    {
      "id": "us-rx-xyzal-levocetirizine-tablet-5mg-90-bottle-ndc-0024-5803-90",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国处方品牌标签（2025-07 修订）",
        "en": "Current U.S. prescription brand label (revised Jul 2025)"
      },
      "dosageForm": {
        "zh": "XYZAL 左西替利嗪处方用普通薄膜衣片",
        "en": "XYZAL prescription immediate-release film-coated tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0024-5803-90",
      "pouchCode": null,
      "applicationNumber": "NDA 022064",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸左西替利嗪 5 mg；90 片瓶装",
        "en": "Levocetirizine dihydrochloride 5 mg per tablet; 90-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-03.jpg&setid=1673f7ff-0c7c-4403-86cf-c05eb1475222&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸左西替利嗪",
            "en": "levocetirizine dihydrochloride"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案",
            "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 90,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-03",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 90,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可",
          "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split"
        },
        "imprint": {
          "zh": "Y / Y（红色）",
          "en": "Y / Y (red)"
        },
        "scoreStatus": "scored_exact_label_not_universal_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_a25547ae6383083a",
        "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-rx-xyzal-levocetirizine-oral-solution-0-5mg-per-ml-5floz-ndc-0024-5804-05",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国处方品牌标签（2025-07 修订）",
        "en": "Current U.S. prescription brand label (revised Jul 2025)"
      },
      "dosageForm": {
        "zh": "XYZAL 左西替利嗪处方用口服溶液",
        "en": "XYZAL prescription oral solution"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 0024-5804-05",
      "pouchCode": null,
      "applicationNumber": "NDA 022157",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_5_mL",
      "primaryDisplay": {
        "zh": "每 5 mL 含盐酸左西替利嗪 2.5 mg（0.5 mg/mL）；5 液量盎司瓶装",
        "en": "Levocetirizine dihydrochloride 2.5 mg per 5 mL (0.5 mg/mL); 5 fl oz bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-02.jpg&setid=1673f7ff-0c7c-4403-86cf-c05eb1475222&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸左西替利嗪",
            "en": "levocetirizine dihydrochloride"
          },
          "value": 2.5,
          "unit": "mg",
          "basisCode": "per_5_mL",
          "basisLabel": {
            "zh": "每 5 mL 标签标示量；0.5 mg/mL 是浓度，不是个人量取方案",
            "en": "labelled amount per 5 mL; 0.5 mg/mL is a concentration, not an individual measuring plan"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "聚丙烯瓶",
          "en": "polypropylene bottle"
        },
        "fill": null,
        "countPerPackage": 5,
        "countUnit": {
          "zh": "液量盎司/瓶",
          "en": "fl oz per bottle"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-03",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 5,
        "unit": {
          "zh": "液量盎司/瓶",
          "en": "fl oz per bottle"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "无色溶液",
          "en": "colourless solution"
        },
        "shape": {
          "zh": "口服液体；必须使用适合的量取工具",
          "en": "oral liquid; an appropriate measuring device is required"
        },
        "imprint": {
          "zh": "不适用",
          "en": "not applicable"
        },
        "scoreStatus": null,
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_a25547ae6383083a",
        "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-otc-xyzal-allergy-24hr-5mg-10-blister-ndc-41167-3510-0",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国 OTC Drug Facts（2026-03）",
        "en": "Current U.S. OTC Drug Facts (Mar 2026)"
      },
      "dosageForm": {
        "zh": "XYZAL ALLERGY 24HR 左西替利嗪非处方普通片",
        "en": "XYZAL ALLERGY 24HR nonprescription immediate-release tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 41167-3510-0",
      "pouchCode": null,
      "applicationNumber": "NDA 209089",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸左西替利嗪 5 mg；10 片泡罩装",
        "en": "Levocetirizine dihydrochloride 5 mg per tablet; 10-tablet blister pack"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-allergy-24hr-01.jpg&setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸左西替利嗪",
            "en": "levocetirizine dihydrochloride"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案",
            "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister",
        "typeLabel": {
          "zh": "泡罩装",
          "en": "blister pack"
        },
        "fill": null,
        "countPerPackage": 10,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-03",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 10,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可",
          "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split"
        },
        "imprint": {
          "zh": "X / X",
          "en": "X / X"
        },
        "scoreStatus": "scored_exact_label_not_universal_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_24d87dd00ec75624",
        "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-otc-xyzal-allergy-24hr-5mg-35-bottle-ndc-41167-3510-1",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国 OTC Drug Facts（2026-03）",
        "en": "Current U.S. OTC Drug Facts (Mar 2026)"
      },
      "dosageForm": {
        "zh": "XYZAL ALLERGY 24HR 左西替利嗪非处方普通片",
        "en": "XYZAL ALLERGY 24HR nonprescription immediate-release tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 41167-3510-1",
      "pouchCode": null,
      "applicationNumber": "NDA 209089",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸左西替利嗪 5 mg；35 片瓶装",
        "en": "Levocetirizine dihydrochloride 5 mg per tablet; 35-tablet bottle"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-allergy-24hr-02.jpg&setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸左西替利嗪",
            "en": "levocetirizine dihydrochloride"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案",
            "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "bottle",
        "typeLabel": {
          "zh": "瓶装",
          "en": "bottle"
        },
        "fill": null,
        "countPerPackage": 35,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-03",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 35,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可",
          "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split"
        },
        "imprint": {
          "zh": "X / X",
          "en": "X / X"
        },
        "scoreStatus": "scored_exact_label_not_universal_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_24d87dd00ec75624",
        "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    },
    {
      "id": "us-otc-xyzal-allergy-24hr-5mg-20-blister-ndc-41167-3511-2",
      "marketCode": "US",
      "labelVersion": {
        "zh": "DailyMed 当前美国 OTC Drug Facts（2026-03）",
        "en": "Current U.S. OTC Drug Facts (Mar 2026)"
      },
      "dosageForm": {
        "zh": "XYZAL ALLERGY 24HR 左西替利嗪非处方普通片",
        "en": "XYZAL ALLERGY 24HR nonprescription immediate-release tablet"
      },
      "route": {
        "zh": "口服",
        "en": "oral"
      },
      "routeCodes": [
        "oral"
      ],
      "productCode": "NDC 41167-3511-2",
      "pouchCode": null,
      "applicationNumber": "NDA 209089",
      "presentationRole": null,
      "primaryStrengthBasisCode": "per_tablet",
      "primaryDisplay": {
        "zh": "每片盐酸左西替利嗪 5 mg；20 片泡罩装",
        "en": "Levocetirizine dihydrochloride 5 mg per tablet; 20-tablet blister pack"
      },
      "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-allergy-24hr-03.jpg&setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41&type=img",
      "visualStatus": "exact_public_label_package_image",
      "labeledQuantities": [
        {
          "ingredient": {
            "zh": "盐酸左西替利嗪",
            "en": "levocetirizine dihydrochloride"
          },
          "value": 5,
          "unit": "mg",
          "basisCode": "per_tablet",
          "basisLabel": {
            "zh": "每片标签标示量；不是所有人的片数、频率、停用或恢复方案",
            "en": "labelled amount per tablet; not a universal tablet count, frequency, stopping or restart plan"
          }
        }
      ],
      "concentration": null,
      "container": {
        "typeCode": "blister",
        "typeLabel": {
          "zh": "泡罩装",
          "en": "blister pack"
        },
        "fill": null,
        "countPerPackage": 20,
        "countUnit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "deliveryDevice": null,
      "compatibleReusableDevice": null,
      "listingStatus": {
        "reviewedAt": "2026-09-03",
        "currentLabelDisplayed": true,
        "ndcDirectoryListed": true,
        "marketAvailability": "current_regulatory_listing_not_live_stock",
        "marketingStartDate": null,
        "marketingEndDate": null,
        "purpleBookPresentationStatus": null,
        "statusConflictRequiresManualReview": false
      },
      "package": {
        "count": 20,
        "unit": {
          "zh": "片/包装",
          "en": "tablets per pack"
        }
      },
      "physicalClues": {
        "color": {
          "zh": "白色",
          "en": "white"
        },
        "shape": {
          "zh": "椭圆形、有刻痕片；刻痕是准确产品线索，不是所有人自行掰片的通用许可",
          "en": "oval scored tablet; the score is an exact-product clue, not universal permission to self-split"
        },
        "imprint": {
          "zh": "X / X",
          "en": "X / X"
        },
        "scoreStatus": "scored_exact_label_not_universal_self_split_permission",
        "patchAreaCm2": null
      },
      "comparisonNotice": null,
      "source": {
        "id": "src_24d87dd00ec75624",
        "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion"
    }
  ],
  "comparisonPresentations": [],
  "appearanceReferences": [],
  "visualReference": {
    "presentationId": "us-rx-xyzal-levocetirizine-tablet-5mg-90-bottle-ndc-0024-5803-90",
    "status": "historical_public_label_image_not_product_authentication",
    "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=xyzal-03.jpg&setid=1673f7ff-0c7c-4403-86cf-c05eb1475222&type=img",
    "alt": "美国处方 XYZAL 盐酸左西替利嗪 5 mg、NDC 0024-5803-90、90 片瓶装的 DailyMed 官方标签面板",
    "archiveMarket": "美国",
    "labelVersion": "DailyMed 当前美国处方品牌标签（2025-07 修订）",
    "presentation": "处方 XYZAL 5 mg：每片 5 mg，白色椭圆形刻痕片，两侧红色 Y；NDC 0024-5803-90，90 片瓶装。",
    "notice": "此图只对应这一美国处方产品。它不代表 OTC 包装、口服液、ZYRTEC/西替利嗪、其他市场或实时库存，不用于鉴定真伪，也不生成个人片数或掰片方案。",
    "source": {
      "id": "src_a25547ae6383083a",
      "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-03",
      "reviewedAt": "2026-09-03"
    }
  },
  "visualCoverageNote": null,
  "labelReading": {
    "coverage": "drug_specific_source_review",
    "title": {
      "zh": "XYZAL 说明书放大阅读：每片 mg、液体浓度、嗜睡、肾功能与停用后瘙痒",
      "en": "XYZAL enlarged label: mg per tablet, liquid concentration, drowsiness, kidney function and itching after stopping"
    },
    "summary": {
      "zh": "处方与 OTC XYZAL 不是一张可混用的说明。5 mg 是每片量；2.5 mg/5 mL 等于 0.5 mg/mL，是口服液浓度。网页帮助把产品和风险问题说准确，不计算个人片数、毫升数、掰片、停用或恢复方案。",
      "en": "Prescription and OTC XYZAL do not share one interchangeable instruction set. Five mg is the amount per tablet; 2.5 mg/5 mL equals 0.5 mg/mL and describes the oral-solution concentration. The site clarifies product and safety questions but does not calculate an individual's tablets, millilitres, splitting, stopping or restart plan."
    },
    "checks": [
      {
        "zh": "美国 OTC Drug Facts 把 65 岁及以上、肾病、既往排尿困难或膀胱排空困难分别列为先咨询或不使用边界；处方标签也强调肾排泄和排尿潴留风险。老人不能只因“是非处方药”就把它当成人人都能自行使用。",
        "en": "U.S. OTC Drug Facts separately flags age 65 or older, kidney disease, and prior trouble urinating or emptying the bladder for professional review or non-use; the prescription label also emphasizes renal excretion and urinary-retention risk. An OTC status does not make the product suitable for every older adult."
      },
      {
        "zh": "嗜睡、疲劳和反应下降可能影响驾驶、操作设备和跌倒风险；酒精、安眠药、镇静药及其他中枢抑制物可能进一步降低警觉。不要靠自行错开时间来假定风险消失，应把所有处方药、OTC 感冒/过敏药和酒精一起列给药师或医生。",
        "en": "Drowsiness, fatigue and reduced alertness can affect driving, machinery and falls; alcohol, sleep medicines, sedatives and other CNS depressants may further reduce alertness. Do not assume self-spacing removes the risk; list every prescription, OTC cold/allergy product and alcohol use for a pharmacist or clinician."
      },
      {
        "zh": "FDA 2025 通讯说明，长期每日使用后几天内停用可能出现罕见但可能严重的全身瘙痒。该信息不是自行突然停用、恢复或递减的操作指南；计划长期使用或停用后出现严重瘙痒时，应联系当地专业人员。",
        "en": "FDA's 2025 communication says rare but potentially severe widespread itching may begin within days after stopping long-term daily use. This is not a self-directed abrupt-stop, restart or taper guide. Discuss planned long-term use, and contact a local professional if severe itching appears after stopping."
      },
      {
        "zh": "处方片有刻痕、OTC 标签对特定年龄段写有半片文字，但这只属于对应美国准确产品和标签人群。不能把刻痕推广成任何左西替利嗪、任何市场或任何人都可自行掰半；更不能把口服液浓度直接换成片数。",
        "en": "The prescription tablet is scored and the OTC label contains half-tablet wording for defined U.S. label populations, but this belongs only to those exact products and populations. A score does not give universal permission to split any levocetirizine product in any market, and oral-solution concentration must not be converted directly into a tablet count."
      }
    ],
    "source": {
      "id": "src_a25547ae6383083a",
      "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-03",
      "reviewedAt": "2026-09-03"
    },
    "scope": "label_literacy_only_no_individual_dosing_or_substitution"
  },
  "mechanismReading": {
    "title": {
      "zh": "左西替利嗪怎样起作用：阻断外周 H1 受体，不等于所有抗组胺药可以换算",
      "en": "How levocetirizine works: peripheral H1-receptor blockade does not make antihistamines interchangeable"
    },
    "summary": {
      "zh": "标签将左西替利嗪描述为口服 H1 受体拮抗剂，是西替利嗪的 R-对映体。该机制解释过敏症状通路，不判断症状一定由过敏引起，也不建立与西替利嗪、氯雷他定、非索非那定或苯海拉明的 mg 换算、叠加或轮换规则。",
      "en": "The label describes levocetirizine as an oral H1-receptor antagonist and the R-enantiomer of cetirizine. This explains an allergy pathway; it neither proves symptoms are allergic nor creates milligram conversion, combination or rotation rules with cetirizine, loratadine, fexofenadine or diphenhydramine."
    },
    "checks": [
      {
        "zh": "“第二代”或“不那么嗜睡”不是没有嗜睡。个体反应、年龄、肾功能、酒精和其他镇静药都需要一起核对。",
        "en": "‘Second generation’ or ‘less sedating’ does not mean no drowsiness. Individual response, age, kidney function, alcohol and other sedatives need review together."
      },
      {
        "zh": "XYZAL 与 ZYRTEC 成分相关但不是同一个准确产品；共同机制不表示可以同服、隔天轮换、按 mg 对换或互相补服。",
        "en": "XYZAL and ZYRTEC are related in chemistry but are not the same exact product. A shared mechanism does not permit co-use, alternate-day rotation, milligram exchange or make-up use with one another."
      },
      {
        "zh": "鼻塞、皮疹、瘙痒或流涕也可能有其他原因；呼吸困难、面唇舌喉肿胀、意识改变或其他严重症状应立即使用当地急救渠道，而不是继续在网页比较抗过敏药。",
        "en": "Congestion, rash, itching or a runny nose can have other causes. Trouble breathing, swelling of the face/lips/tongue/throat, altered awareness or another severe symptom requires local emergency help rather than continued website comparison of allergy medicines."
      }
    ],
    "source": {
      "id": "src_a25547ae6383083a",
      "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-03",
      "reviewedAt": "2026-09-03"
    },
    "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution"
  },
  "pharmacovigilance": {
    "status": "official_routes_only_no_live_alert_inference",
    "reviewedAt": "2026-08-22",
    "identity": {
      "brand": "XYZAL",
      "generic": "盐酸左西替利嗪片与口服溶液",
      "dosageFormClass": "普通口服片与口服溶液。5 mg 是每片含量；2.5 mg/5 mL 与 0.5 mg/mL 是同一口服液浓度的两种写法。片剂数字、液体浓度、瓶装/泡罩片数不能相加，也不能自行换成个人片数或毫升数。"
    },
    "labelSource": {
      "id": "src_a25547ae6383083a",
      "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
      "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
      "audience": "public",
      "reviewStatus": "approved",
      "publish": true,
      "documentStatus": "current_regulatory_record",
      "documentKind": "product_label",
      "market": "US",
      "accessStatus": "public_access_confirmed",
      "accessMode": "public_web_page",
      "accessVerifiedAt": "2026-09-03",
      "reviewedAt": "2026-09-03"
    },
    "productRoutes": [
      {
        "source": {
          "id": "src_a25547ae6383083a",
          "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        },
        "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": "2026-09-03",
        "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_24d87dd00ec75624",
          "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）",
          "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "current_regulatory_record",
          "documentKind": "product_label",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        },
        "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": "2026-09-03",
        "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": "2026-09-03",
      "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": [
      {
        "id": "fda-2025-levocetirizine-xyzal-pruritus-after-stopping-safety-communication",
        "issuedAt": "2025-05-16",
        "status": "fda_drug_safety_communication",
        "title": {
          "zh": "FDA 药物安全通讯：停止长期使用口服左西替利嗪／XYZAL 后罕见但可能严重的瘙痒",
          "en": "FDA Drug Safety Communication: rare but severe itching after stopping long-term oral levocetirizine/XYZAL"
        },
        "summary": {
          "zh": "FDA 于 2025-05-16 说明，长期规律使用口服左西替利嗪或西替利嗪后停用，可能出现罕见但可能严重的瘙痒；通讯覆盖美国处方与非处方产品并要求标签更新。该监管记录不能判断任何个人是否会发生问题，也不提供自行停用、恢复、递减、换药或与另一种抗组胺药叠加的方案。计划长期使用或停用后出现严重瘙痒时，请带实际包装和完整药单联系当地药师、开方团队或医疗服务。",
          "en": "On 16 May 2025, FDA said rare but potentially severe itching can occur after stopping long-term regular use of oral levocetirizine or cetirizine; the communication covers U.S. prescription and nonprescription products and requires label updates. This regulator record cannot predict an individual event or provide a self-directed stop, restart, taper, switch or antihistamine-combination plan. Discuss planned long-term use, and contact a local pharmacist, prescriber or medical service with the actual pack and complete medicine list if severe itching appears after stopping."
        },
        "source": {
          "id": "src_72aeda1f7f249ce3",
          "label": "FDA：2025-05-16 停止长期使用口服左西替利嗪／XYZAL 后瘙痒的药物安全通讯",
          "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        }
      }
    ],
    "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": "XYZAL 是左西替利嗪品牌档案。老人、多药使用者和有肾功能或排尿问题者，应优先核对嗜睡、酒精/镇静药叠加、驾驶跌倒、排尿困难和停用长期规律用药后新发严重瘙痒。网页解释“每片 mg、每 5 mL、mg/mL、包装片数”的区别，不替个人决定吃几片、量几毫升、是否掰片、停用、恢复或换成另一种抗过敏药。",
    "history": "FDA 资料显示，XYZAL 处方片于 2007 年获批，口服液于 2008 年获批，2017 年完成 OTC 转换。FDA 于 2025-05-16 发布安全通讯，要求处方与 OTC 口服西替利嗪/左西替利嗪标签加入长期使用后停用可能出现罕见但严重瘙痒的警示。",
    "sourceDocuments": [
      {
        "id": "src_a25547ae6383083a",
        "label": "DailyMed（NLM）：XYZAL 左西替利嗪当前美国处方标签（2025-07 修订）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=1673f7ff-0c7c-4403-86cf-c05eb1475222",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      {
        "id": "src_24d87dd00ec75624",
        "label": "DailyMed（NLM）：XYZAL ALLERGY 24HR 左西替利嗪当前美国 OTC Drug Facts 与包装面板（SPL v14，2026-03）",
        "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=8be45c2a-1eca-4a00-81b9-f7babdbdcd41",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "current_regulatory_record",
        "documentKind": "product_label",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      {
        "id": "src_72aeda1f7f249ce3",
        "label": "FDA：2025-05-16 停止长期使用口服西替利嗪或左西替利嗪后罕见但可能严重瘙痒的药物安全通讯",
        "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_public_record",
        "documentKind": "regulatory_safety_communication",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "public_web_page",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      },
      {
        "id": "src_77cac6b160e47365",
        "label": "FDA：XYZAL ALLERGY 24HR NDA 209089/209090 OTC 转换审评资料（2017）",
        "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000OtherR.pdf",
        "audience": "public",
        "reviewStatus": "approved",
        "publish": true,
        "documentStatus": "dated_regulatory_document",
        "documentKind": "regulatory_review",
        "market": "US",
        "accessStatus": "public_access_confirmed",
        "accessMode": "direct_document",
        "accessVerifiedAt": "2026-09-03",
        "reviewedAt": "2026-09-03"
      }
    ],
    "applicationNumber": "NDA 022064 / NDA 022157 / NDA 209089",
    "approvalTimeline": [
      {
        "date": "2007",
        "title": {
          "zh": "XYZAL 处方片在美国获批",
          "en": "U.S. approval of prescription XYZAL tablets"
        },
        "detail": {
          "zh": "FDA 儿科审评资料将 NDA 022064 与 2007 年左西替利嗪片批准相连。",
          "en": "FDA pediatric review links NDA 022064 to the 2007 approval of levocetirizine tablets."
        },
        "source": {
          "id": "src_77cac6b160e47365",
          "label": "FDA：XYZAL ALLERGY 24HR NDA 209089/209090 OTC 转换审评资料（2017）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000OtherR.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "regulatory_review",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        }
      },
      {
        "date": "2017-01-31",
        "title": {
          "zh": "XYZAL ALLERGY 24HR 完成美国 OTC 转换",
          "en": "U.S. OTC switch for XYZAL ALLERGY 24HR"
        },
        "detail": {
          "zh": "NDA 209089 的 OTC 审评资料覆盖 5 mg 抗组胺片。",
          "en": "The NDA 209089 OTC review covers the 5 mg antihistamine tablet."
        },
        "source": {
          "id": "src_77cac6b160e47365",
          "label": "FDA：XYZAL ALLERGY 24HR NDA 209089/209090 OTC 转换审评资料（2017）",
          "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2017/209089Orig1s000_209090Orig1s000OtherR.pdf",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_regulatory_document",
          "documentKind": "regulatory_review",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "direct_document",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        }
      },
      {
        "date": "2025-05-16",
        "title": {
          "zh": "FDA 发布停用后严重瘙痒安全通讯",
          "en": "FDA issued its severe-itching-after-stopping communication"
        },
        "detail": {
          "zh": "通讯涵盖处方和 OTC 口服西替利嗪/左西替利嗪，并要求标签更新。",
          "en": "The communication covers prescription and OTC oral cetirizine/levocetirizine and requires label updates."
        },
        "source": {
          "id": "src_72aeda1f7f249ce3",
          "label": "FDA：2025-05-16 停止长期使用口服西替利嗪或左西替利嗪后罕见但可能严重瘙痒的药物安全通讯",
          "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-warning-about-rare-severe-itching-after-stopping-long-term-use-oral-allergy-medicines",
          "audience": "public",
          "reviewStatus": "approved",
          "publish": true,
          "documentStatus": "dated_public_record",
          "documentKind": "regulatory_safety_communication",
          "market": "US",
          "accessStatus": "public_access_confirmed",
          "accessMode": "public_web_page",
          "accessVerifiedAt": "2026-09-03",
          "reviewedAt": "2026-09-03"
        }
      }
    ],
    "marketStatus": [
      {
        "market": {
          "zh": "美国处方",
          "en": "U.S. prescription"
        },
        "status": {
          "zh": "当前公开标签",
          "en": "Current public label"
        },
        "detail": {
          "zh": "5 mg 片与 0.5 mg/mL 口服液；NDA 022064/022157。",
          "en": "5 mg tablets and 0.5 mg/mL oral solution; NDA 022064/022157."
        }
      },
      {
        "market": {
          "zh": "美国 OTC",
          "en": "U.S. OTC"
        },
        "status": {
          "zh": "当前 Drug Facts 与包装记录",
          "en": "Current Drug Facts and package records"
        },
        "detail": {
          "zh": "XYZAL ALLERGY 24HR 5 mg 片；NDA 209089。",
          "en": "XYZAL ALLERGY 24HR 5 mg tablets; NDA 209089."
        }
      },
      {
        "market": {
          "zh": "美国以外",
          "en": "Outside the United States"
        },
        "status": {
          "zh": "本档案未确认当地产品",
          "en": "Local products not established in this dossier"
        },
        "detail": {
          "zh": "必须回到当地监管记录和手中药盒，不沿用美国 OTC/处方边界。",
          "en": "Check the local regulator and pack in hand; do not carry U.S. OTC/prescription boundaries across markets."
        }
      }
    ],
    "frequentlyAskedQuestions": [
      {
        "question": {
          "zh": "5 mg 是一天一定吃一片吗？",
          "en": "Does 5 mg always mean one tablet a day?"
        },
        "answer": {
          "zh": "不是。5 mg 是这款片剂每片的标签量；个人是否使用、片数、频率及是否可掰片取决于准确产品、所在市场、年龄、肾功能和专业判断，网页不把规格变成处方。",
          "en": "No. Five mg is the labelled amount in one tablet. Whether to use it, tablet count, frequency and splitting depend on the exact product, market, age, kidney function and professional review; the site does not turn strength into a prescription."
        }
      },
      {
        "question": {
          "zh": "能和 ZYRTEC、西替利嗪或其他抗过敏药一起吃吗？",
          "en": "Can it be taken with ZYRTEC, cetirizine or another allergy medicine?"
        },
        "answer": {
          "zh": "不能由网页这样决定。名称、类别或机制相关不等于可以叠加、轮换或换算；把所有处方和 OTC 感冒/过敏药的完整成分表交给药师或医生核对，避免同成分或同作用重复。",
          "en": "A website cannot make that decision. Related names, class or mechanism do not permit combination, rotation or conversion. Give a pharmacist or clinician the full ingredient lists for every prescription and OTC cold/allergy product to check for duplication."
        }
      },
      {
        "question": {
          "zh": "长期每天吃后可以突然停吗？",
          "en": "Can long-term daily use be stopped suddenly?"
        },
        "answer": {
          "zh": "FDA 已提醒长期规律使用后停用可能出现罕见但严重瘙痒，但该通讯不是网页递减或恢复方案。计划长期使用或停用前请咨询专业人员；停用后出现严重瘙痒应尽快联系医疗支持。",
          "en": "FDA warns that rare but severe itching can occur after stopping long-term regular use, but the communication is not a website taper or restart plan. Discuss planned long-term use or stopping with a professional, and seek prompt help for severe itching after stopping."
        }
      }
    ],
    "relatedMedicineChecks": [],
    "relatedArticleSlugs": [
      "medicine-label-for-everyday-questions",
      "dose-unit-literacy",
      "same-class-is-not-same-medicine",
      "interactions-are-not-a-home-scheduling-problem"
    ]
  },
  "canonicalUrls": {
    "zh": "https://origindrug.com/drugs/xyzal-levocetirizine/",
    "en": "https://origindrug.com/en/drugs/xyzal-levocetirizine/"
  },
  "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."
  ]
}