{ "id": "singulair", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-22", "status": "published_traceable_archive" }, "names": { "brand": "Singulair", "generic": "孟鲁司特钠", "aliases": [ "montelukast", "montelukast sodium", "孟鲁司特", "孟鲁司特钠", "孟鲁司特钠片", "顺尔宁" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": { "value": "顺尔宁®", "status": "discovery_cue_requires_target_market_verification", "source": { "id": "src_d92e446003face44", "label": "汉中市医疗保障局：2026 年常用药品价格监测中的顺尔宁／孟鲁司特钠片 10 mg×5 片记录", "url": "https://ybj.hanzhong.gov.cn/hzsylbzj/qsdt/202607/8fe1915213db4aea9b8bca1d4f473f1e.shtml", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "government_medicine_listing", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-12", "reviewedAt": "2026-09-12" } } }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国当前公开处方药标签（DailyMed SPL v5，2025-06-25 发布；本页只展示四个精确包装面板）", "dosageFormClass": "薄膜衣片、咀嚼片与口服颗粒（本档案所列）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-singulair-montelukast-sodium-oral-granules-4mg-30-packet-carton-ndc-78206-171-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "口服颗粒", "en": "oral granules" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-171-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "孟鲁司特钠 4 mg 口服颗粒；30 袋纸盒", "en": "Montelukast sodium 4 mg oral granules; 30-packet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-04.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 4, "unit": "mg", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标签量；不是个人袋数、频率或混合方案", "en": "labelled amount per packet; not an individual's packet count, frequency or mixing plan" } } ], "concentration": null, "container": { "typeCode": "carton_with_child_resistant_foil_packets", "typeLabel": { "zh": "含儿童安全铝箔袋的纸盒", "en": "carton with child-resistant foil packets" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "袋/盒", "en": "packets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "袋/盒", "en": "packets per carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "口服颗粒，单袋包装", "en": "oral granules in an individual packet" }, "imprint": null, "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-singulair-montelukast-sodium-chewable-tablet-4mg-30-bottle-ndc-78206-170-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "咀嚼片", "en": "chewable oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-170-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "孟鲁司特钠 4 mg 咀嚼片；30 片瓶装", "en": "Montelukast sodium 4 mg chewable tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-05.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 4, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或换用方案", "en": "labelled amount per tablet; not an individual's tablet count, frequency or switching plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "椭圆形双凸咀嚼片", "en": "oval biconvex chewable tablet" }, "imprint": "MSD 711 / SINGULAIR", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-singulair-montelukast-sodium-chewable-tablet-5mg-30-bottle-ndc-78206-173-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "咀嚼片", "en": "chewable oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-173-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "孟鲁司特钠 5 mg 咀嚼片；30 片瓶装", "en": "Montelukast sodium 5 mg chewable tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-06.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或换用方案", "en": "labelled amount per tablet; not an individual's tablet count, frequency or switching plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形双凸咀嚼片", "en": "round biconvex chewable tablet" }, "imprint": "MSD 275 / SINGULAIR", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-singulair-montelukast-sodium-film-coated-tablet-10mg-30-bottle-ndc-78206-172-01", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5（2025-06-25 发布）", "en": "DailyMed SPL v5 (published 25 Jun 2025)" }, "dosageForm": { "zh": "薄膜衣口服片", "en": "film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 78206-172-01", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "孟鲁司特钠 10 mg 薄膜衣片；30 片瓶装", "en": "Montelukast sodium 10 mg film-coated tablet; 30-tablet bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-07.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "孟鲁司特", "en": "montelukast" }, "value": 10, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签量；不是个人片数、频率或换用方案", "en": "labelled amount per tablet; not an individual's tablet count, frequency or switching plan" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "高密度聚乙烯瓶", "en": "high-density polyethylene bottle" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": null, "package": { "count": 30, "unit": { "zh": "片/瓶", "en": "tablets per bottle" } }, "physicalClues": { "color": { "zh": "米色", "en": "beige" }, "shape": { "zh": "圆角方形薄膜衣片", "en": "rounded-square film-coated tablet" }, "imprint": "MSD 117 / SINGULAIR", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-singulair-montelukast-sodium-oral-granules-4mg-30-packet-carton-ndc-78206-171-01", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=singulair-04.jpg&setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842&type=img", "alt": "SINGULAIR 孟鲁司特钠在美国 DailyMed Organon 公开标签中的 4 mg 口服颗粒、30 袋装外盒展开图", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5（Organon，2025-06-25 发布）", "presentation": "SINGULAIR 孟鲁司特钠口服颗粒：每袋 4 mg、30 袋装外盒展开图（DailyMed Organon 公开标签所列）。", "notice": "此为美国 DailyMed Organon 公开标签中明确对应 SINGULAIR、孟鲁司特钠 4 mg 口服颗粒、30 袋装的外盒展开图，只帮助核对品牌、通用名、口服颗粒、标示强度、包装数量和来源；不用于鉴定真伪，也不证明咀嚼片、其他规格、其他包装、其他市场标签、当前可得性、原研身份、目标市场批准或可售资格。", "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "SINGULAIR 说明书放大阅读：片剂、咀嚼片和口服颗粒是不同的产品形态", "en": "SINGULAIR label reading: tablets, chewables and oral granules are distinct product forms" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助区分 SINGULAIR、孟鲁司特钠、薄膜衣片、咀嚼片、口服颗粒和目标市场。它不提供个人剂量、开始/停用、急性症状处理或与其他呼吸/过敏药的联用方案。", "en": "This module uses the U.S. DailyMed public label to distinguish SINGULAIR, montelukast sodium, film-coated tablets, chewable tablets, oral granules and target market. It does not provide individual dosing, start/stop, acute-symptom management or a combination plan with another respiratory/allergy medicine." }, "checks": [ { "zh": "先核对商品名 SINGULAIR、孟鲁司特钠、准确剂型、每单位标示强度和目标市场。相同通用名不能把薄膜衣片、咀嚼片与颗粒按片数、包数或经验自行换算或替换。", "en": "Check SINGULAIR, montelukast sodium, the exact form, stated strength per unit and target market together. A shared non-proprietary name does not make film-coated tablets, chewables and granules self-convertible or substitutable by tablet count, sachet count or experience." }, { "zh": "标签包含神经精神事件警示。出现新的或令人担忧的情绪、行为、睡眠或思维变化时，应及时按当地医疗渠道联系专业人员；不要仅凭网页自行停药、恢复用药、加量或改用另一种药。", "en": "The label includes a neuropsychiatric-events warning. With a new or concerning change in mood, behaviour, sleep or thinking, promptly contact a professional through local medical channels; do not self-stop, restart, increase or change to another medicine from a webpage." }, { "zh": "该标签也明确本品不用于逆转急性支气管痉挛。突然或加重的呼吸困难不应通过自行多用、等待网页回复或借用他人药物处理，而应按当地急救与医疗团队指引处置。", "en": "The label also says this product is not for reversal of acute bronchospasm. Sudden or worsening breathing difficulty should not be managed by self-escalation, waiting for a webpage or borrowing another person's medicine; use local emergency and care-team guidance." }, { "zh": "包装图、名称与“过敏/哮喘”用途文字只能帮助定位标签，不能证明真伪、当前批准或与另一种抗过敏、吸入或急救产品可互换。每次新增、停用或更换产品时，应让药师核对完整药单。", "en": "Package images, a name and “allergy/asthma” wording only help locate a label. They cannot authenticate a product, establish current approval or prove interchangeability with another allergy, inhaled or rescue product. Ask a pharmacist to review the complete medicine list with every addition, stop or change." } ], "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "孟鲁司特怎样起作用：它阻断 CysLT1 白三烯受体，但不能替代急性呼吸处理", "en": "How montelukast works: it blocks the CysLT1 leukotriene receptor but does not replace acute breathing care" }, "summary": { "zh": "DailyMed 标签将孟鲁司特描述为口服活性白三烯受体拮抗剂，可高亲和力、选择性结合 CysLT1 受体。这个机制帮助读者理解药物类别和标签边界；它不能判断某个人的喘息、过敏症状、急性风险、产品选择或个人使用方式。", "en": "The DailyMed label describes montelukast as an orally active leukotriene receptor antagonist that binds the CysLT1 receptor with high affinity and selectivity. This mechanism helps explain drug class and label boundaries; it cannot judge an individual's wheeze, allergy symptoms, acute risk, product choice or use." }, "checks": [ { "zh": "“白三烯受体拮抗剂”是作用路径说明，不是把所有咳嗽、喘鸣、胸闷、鼻塞或皮疹自动归因于同一种病因，也不能替代诊断。", "en": "“Leukotriene receptor antagonist” describes an action pathway. It does not automatically attribute every cough, wheeze, chest tightness, congestion or rash to one cause, and it cannot replace diagnosis." }, { "zh": "共同的过敏或呼吸用途文字不使孟鲁司特与抗组胺药、吸入产品、急救药或另一种剂型可以自行叠加、替换或按毫克数换算。", "en": "Shared allergy or respiratory-use wording does not make montelukast self-combinable, substitutable or convertible by milligrams with an antihistamine, inhaled product, rescue medicine or another form." }, { "zh": "机制不能把非急性维持性产品变成突然或加重呼吸困难时的自行处理方案。出现急性症状、令人担忧的行为/情绪变化或需要改变用药时，应使用当地医疗渠道并携带完整药单。", "en": "Mechanism cannot turn a non-acute maintenance product into a self-management plan for sudden or worsening breathing difficulty. With acute symptoms, concerning behaviour/mood changes or a need to change use, use local medical pathways and bring the complete medicine list." } ], "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（临床药理；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Singulair", "generic": "孟鲁司特钠", "dosageFormClass": "薄膜衣片、咀嚼片与口服颗粒（本档案所列）" }, "labelSource": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "productRoutes": [ { "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-20", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "channels": [ { "id": "china-nmpa-drug-evaluation-centre", "authority": "NMPA 药品评价中心", "market": { "zh": "中国大陆", "en": "Mainland China" }, "title": { "zh": "药物警戒快讯与安全警示", "en": "Drug-vigilance bulletins and safety notices" }, "purpose": { "zh": "国家药监局药品评价中心发布的药物警戒快讯、安全警示及药品不良反应监测相关原始入口；具体产品仍须按批准文号、剂型、规格、持有人和公告日期逐项核对。", "en": "Primary NMPA Drug Evaluation Centre gateway for drug-vigilance bulletins, safety notices and adverse-reaction monitoring. Exact products still require checking approval number, dosage form, strength, authorisation holder and notice date item by item." }, "source": { "id": "src_05ff2860226564d4", "label": "国家药监局药品评价中心：药物警戒与安全警示入口", "url": "https://www.cdr-adr.org.cn/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CN", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-drug-safety-communications", "authority": "FDA", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "药物安全通讯", "en": "Drug Safety Communications" }, "purpose": { "zh": "监管机构就重要新安全问题、标签变化或风险沟通发布的原始页面。", "en": "Primary FDA pages for important new safety issues, labelling changes and risk communications." }, "source": { "id": "src_9177df9e1825aa72", "label": "FDA：Drug Safety Communications", "url": "https://www.fda.gov/drugs/drug-safety-and-availability/drug-safety-communications", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "fda-medwatch", "authority": "FDA MedWatch", "market": { "zh": "美国", "en": "United States" }, "title": { "zh": "安全信息与严重问题报告", "en": "Safety information and serious-problem reporting" }, "purpose": { "zh": "美国 MedWatch 的安全信息和报告入口；报告不等同于已证实因果关系。", "en": "U.S. MedWatch safety-information and reporting gateway; a report does not itself establish causality." }, "source": { "id": "src_e4739cd55d27ab51", "label": "FDA：MedWatch 药品安全信息与不良事件报告计划", "url": "https://www.fda.gov/safety/medwatch-fda-safety-information-and-adverse-event-reporting-program", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "ema-pharmacovigilance", "authority": "EMA", "market": { "zh": "欧盟/欧洲经济区", "en": "European Union / European Economic Area" }, "title": { "zh": "药物警戒概览与 EudraVigilance", "en": "Pharmacovigilance overview and EudraVigilance" }, "purpose": { "zh": "欧盟药物警戒、疑似不良反应报告和 PRAC 安全评估的官方入口。", "en": "Official EU gateway for pharmacovigilance, suspected adverse-reaction reports and PRAC safety assessment." }, "source": { "id": "src_2ad42a3deae747d1", "label": "EMA：Pharmacovigilance overview", "url": "https://www.ema.europa.eu/en/human-regulatory-overview/pharmacovigilance-overview", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "EU", "accessStatus": "public_access_confirmed", "accessMode": "javascript_or_cookie_controls", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mhra-drug-safety-update", "authority": "MHRA", "market": { "zh": "英国", "en": "United Kingdom" }, "title": { "zh": "Drug Safety Update", "en": "Drug Safety Update" }, "purpose": { "zh": "英国 MHRA 面向专业人士和公众的药品安全更新原始发布页。", "en": "Primary UK MHRA medicine-safety updates for professionals and the public." }, "source": { "id": "src_23fdbe67abeafc63", "label": "MHRA：Drug Safety Update", "url": "https://www.gov.uk/drug-safety-update", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "UK", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "pmda-drug-safety", "authority": "PMDA", "market": { "zh": "日本", "en": "Japan" }, "title": { "zh": "药品安全信息", "en": "Medicine safety information" }, "purpose": { "zh": "日本 PMDA 药品安全信息的英文官方入口；具体产品仍应以日文产品页和现行文件复核。", "en": "PMDA’s English official safety gateway; exact products still require checking against the Japanese product page and current documents." }, "source": { "id": "src_06d6be2880f12024", "label": "PMDA：Safety Information Regarding Drugs", "url": "https://www.pmda.go.jp/english/safety/info-services/drugs/0001.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "JP", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "mfds-drug-safety-letters", "authority": "MFDS", "market": { "zh": "韩国", "en": "Republic of Korea" }, "title": { "zh": "药品安全性书信", "en": "Medicine safety letters" }, "purpose": { "zh": "韩国 MFDS 发布的药品安全性书信原始索引。原文为韩文，须按涉及产品、剂型、市场和日期逐项阅读；它不自动适用于其他市场，也不构成对个人情况的结论。", "en": "MFDS’s primary index for medicine safety letters in the Republic of Korea. The original notices are in Korean and must be read against the named product, dosage form, market and date; they do not automatically apply in another market or decide an individual case." }, "source": { "id": "src_2d7f5018cd05eff4", "label": "MFDS：药品安全性书信（韩文原始资料）", "url": "https://www.mfds.go.kr/brd/m_545/list.do", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "KR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "hsa-adverse-events", "authority": "HSA", "market": { "zh": "新加坡", "en": "Singapore" }, "title": { "zh": "不良反应报告与药物安全信息", "en": "Adverse-event reporting and medicine-safety information" }, "purpose": { "zh": "新加坡 HSA 面向公众的疑似不良反应报告、药物安全信息与本地监管入口；一份报告不等同于个体因果关系，具体产品仍须按新加坡注册状态、剂型、规格、日期和现行产品资料逐项核对。", "en": "HSA’s public Singapore gateway for suspected adverse-event reporting and medicine-safety information. A report does not itself establish individual causality; exact products still require checking Singapore registration status, dosage form, strength, date and current product information." }, "source": { "id": "src_9240397d5a8574c1", "label": "HSA：Report adverse events", "url": "https://www.hsa.gov.sg/adverse-events/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "SG", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "health-canada-medeffect-advisories", "authority": "Health Canada", "market": { "zh": "加拿大", "en": "Canada" }, "title": { "zh": "MedEffect 加拿大：建议、警告与召回", "en": "MedEffect Canada: advisories, warnings and recalls" }, "purpose": { "zh": "加拿大政府 Health Canada 的 MedEffect 公开入口，汇集药品及健康产品的建议、警告、召回、报告与安全信息；具体产品仍须按市场、剂型、规格、公告日期和批号逐项核对。", "en": "Health Canada’s public MedEffect gateway for medicine and health-product advisories, warnings, recalls, reporting and safety information. Exact products still require checking market, dosage form, strength, notice date and lot item by item." }, "source": { "id": "src_212ec921fa6634ad", "label": "Health Canada：MedEffect Canada 建议、警告与召回", "url": "https://www.canada.ca/en/health-canada/services/drugs-health-products/medeffect-canada/advisories-warnings-recalls.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "CA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "tga-safety-alerts", "authority": "TGA", "market": { "zh": "澳大利亚", "en": "Australia" }, "title": { "zh": "药品安全警示", "en": "Medicine safety alerts" }, "purpose": { "zh": "澳大利亚 TGA 的药品安全警示、建议和监测信息原始发布页。", "en": "Primary Australian TGA safety alerts, advisories and monitoring information for therapeutic products." }, "source": { "id": "src_ffe6142814f88fac", "label": "TGA：Safety alerts", "url": "https://www.tga.gov.au/safety/safety-monitoring-and-information/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "AU", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "swissmedic-pharmacovigilance", "authority": "Swissmedic", "market": { "zh": "瑞士", "en": "Switzerland" }, "title": { "zh": "药物警戒与不良反应报告", "en": "Pharmacovigilance and suspected adverse-reaction reporting" }, "purpose": { "zh": "瑞士 Swissmedic 的药物警戒、信号评估和疑似不良反应官方入口；报告或信号本身不等同于对个体因果关系的确认。", "en": "Official Swissmedic gateway for pharmacovigilance, signal assessment and suspected adverse-reaction reporting; a report or signal does not itself confirm individual causality." }, "source": { "id": "src_c854f813ce2671df", "label": "Swissmedic：Pharmacovigilance", "url": "https://www.swissmedic.ch/swissmedic/en/home/humanarzneimittel/market-surveillance/pharmacovigilance.html", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "adverse_event_reporting", "market": "CH", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "medsafe-safety-communications", "authority": "Medsafe", "market": { "zh": "新西兰", "en": "New Zealand" }, "title": { "zh": "药品安全通讯", "en": "Medicine safety communications" }, "purpose": { "zh": "新西兰 Medsafe 面向公众和专业人士的药品安全通讯与归档入口；旧公告可能已被现行产品资料更新。", "en": "New Zealand Medsafe gateway for public and professional medicine safety communications and archives; older notices may have been superseded by current product information." }, "source": { "id": "src_3510c1a523ec9769", "label": "Medsafe：Safety Communications", "url": "https://www.medsafe.govt.nz/safety/SafetyCommunications.asp", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "NZ", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "sahpra-safety-information", "authority": "SAHPRA", "market": { "zh": "南非", "en": "South Africa" }, "title": { "zh": "药物安全信息、警示与药物警戒", "en": "Medicine safety information, alerts and pharmacovigilance" }, "purpose": { "zh": "南非 SAHPRA 面向公众和专业人士的药物安全信息、警示与药物警戒入口；官方警示不等同于产品在所有情形下不安全，具体产品仍须按南非注册状态、剂型、规格、公告日期与现行资料逐项核对。", "en": "SAHPRA’s safety-information, alerts and pharmacovigilance gateway for the public and professionals in South Africa. An official alert does not itself mean a product is unsafe in every circumstance; exact products still require checking South African registration status, dosage form, strength, notice date and current product information." }, "source": { "id": "src_25b0aaefee742163", "label": "SAHPRA：Safety Information Updates / Pharmacovigilance", "url": "https://www.sahpra.org.za/safety-information-and-updates/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "ZA", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "who-medicine-safety-alerts", "authority": "WHO", "market": { "zh": "全球", "en": "Global" }, "title": { "zh": "药品与疫苗安全警示档案", "en": "Medicine and vaccine safety-alert archive" }, "purpose": { "zh": "WHO 的跨市场安全警示档案；每条历史警示必须按公告日期、涉及产品和市场单独阅读。", "en": "WHO’s cross-market safety-alert archive; every historical notice must be read against its date, named product and market." }, "source": { "id": "src_9a7dc56ec34c7e1a", "label": "WHO：Safety alerts for medicines and vaccines", "url": "https://www.who.int/teams/regulation-prequalification/regulation-and-safety/pharmacovigilance/safety-alerts", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "GLOBAL", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } }, { "id": "anvisa-pharmacovigilance", "authority": "Anvisa", "market": { "zh": "巴西", "en": "Brazil" }, "title": { "zh": "药物警戒、警示与 VigiMed", "en": "Pharmacovigilance, alerts and VigiMed" }, "purpose": { "zh": "巴西 Anvisa 的药物警戒原始入口，涵盖警示、药物警戒公告、风险沟通和 VigiMed 报告路径；具体产品仍须按巴西批准状态、剂型、规格和公告日期逐项核对。", "en": "Anvisa’s primary Brazilian pharmacovigilance gateway for alerts, bulletins, risk communication and VigiMed reporting. Exact products still require checking Brazilian authorisation status, dosage form, strength and notice date item by item." }, "source": { "id": "src_5de362c12580111d", "label": "Anvisa：Farmacovigilância（药物警戒、警示与 VigiMed）", "url": "https://www.gov.br/anvisa/pt-br/assuntos/fiscalizacao-e-monitoramento/farmacovigilancia", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_safety_monitoring", "documentKind": "regulatory_safety_communication", "market": "BR", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "notices": [ { "id": "fda-2020-montelukast-boxed-warning-safety-communication", "issuedAt": "2020-03-04", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：孟鲁司特（Singulair）精神健康相关风险的黑框警告", "en": "FDA Drug Safety Communication: Boxed Warning for mental-health effects with montelukast (Singulair)" }, "summary": { "zh": "FDA 于 2020-03-04 发布药物安全通讯，说明其在复核资料后要求孟鲁司特（Singulair 及仿制药）的处方信息加入精神与情绪相关不良反应的黑框警告，并要求新的患者用药指南；公告同时说明美国过敏性鼻炎用途的获益/风险考虑。这是特定日期的美国监管通讯，不等于对任何个人症状、适应症或当前治疗的结论。若出现新的或加重的情绪、行为或自伤想法，应立即寻求当地紧急/医疗支持；不要只根据本卡自行开始、停止、替换或调整药物。", "en": "On 2020-03-04, FDA issued a Drug Safety Communication saying that, after reviewing available information, it required a Boxed Warning in prescribing information for montelukast (Singulair and generics) about mental-health effects and a new patient Medication Guide; the communication also describes U.S. benefit-risk considerations for allergic rhinitis. This is a dated U.S. regulatory communication, not a conclusion about any person’s symptoms, indication or current treatment. New or worsening mood, behavior or self-harm thoughts require prompt local emergency or clinical support; do not self-start, stop, switch or adjust a medicine from this card alone." }, "source": { "id": "src_8f82989f9db6c83b", "label": "FDA：2020-03-04 孟鲁司特（Singulair）黑框警告药物安全通讯", "url": "https://www.fda.gov/drugs/drug-safety-communications/fda-requires-boxed-warning-about-serious-mental-health-side-effects-asthma-and-allergy-drug", "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": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "DailyMed 的 SINGULAIR（montelukast sodium）当前美国公开标签列示口服薄膜衣片、咀嚼片和口服颗粒。本页只展示四个与官方包装面板一一对应的美国产品身份，帮助核对同一通用名下不同剂型、标示强度与包装；不生成个人服用数量、替代、联用或治疗方案。", "history": "4 mg 颗粒、4 mg 咀嚼片、5 mg 咀嚼片与 10 mg 薄膜衣片分别对应不同的标签产品形态。共同通用名或毫克数不表示可按片数、包数或经验互换；任何产品变化都应将准确产品、标签、年龄/病情资料和完整药单交由专业人员复核。", "sourceDocuments": [ { "id": "src_1f1ebd6211edd336", "label": "DailyMed（NLM）：SINGULAIR 孟鲁司特钠当前美国公开标签（Organon；SPL v5，2025-06-25 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" }, { "id": "src_5ed30b676fbb9773", "label": "FDA Drugs@FDA 官方检索入口", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "official_lookup_entry", "documentKind": "regulatory_lookup", "market": "US", "accessStatus": "public_access_requires_interaction", "accessMode": "interactive_lookup", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } ], "applicationNumber": "NDA 020829 / 020830 / 021409", "approvalTimeline": [ { "date": "1998", "title": { "zh": "FDA 标签所列美国初始批准年份", "en": "Initial U.S. approval year listed in the FDA label" }, "detail": { "zh": "本页链接的 FDA 标签档案列示 Initial U.S. Approval: 1998。该历史定位不等同于当前批准、可得性、持有人或其他市场状态。", "en": "The FDA label archive linked here lists Initial U.S. Approval: 1998. This historical locator is not a conclusion about current approval, availability, holder or another market." }, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed: SINGULAIR current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } }, { "date": "DailyMed SPL v5, published 2025-06-25", "title": { "zh": "FDA 标签档案版本", "en": "FDA label archive version" }, "detail": { "zh": "本页链接 DailyMed SPL v5, published 2025-06-25 的 FDA 标签档案作为可复核阅读入口。现行标签、规格、适应症和安全信息必须另行以目标市场当前文件核对。", "en": "This page links the DailyMed SPL v5, published 2025-06-25 FDA label archive as a traceable reading entry point. Current labeling, strength, indication and safety information require separate verification against the target market’s current document." }, "source": { "id": "src_1f1ebd6211edd336", "label": "DailyMed: SINGULAIR current public label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=482dcc92-b47f-4ea6-854a-f5ac2aea7842", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "publication_status_unresolved", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-20", "reviewedAt": "2026-08-20" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "已链接公开标签档案", "en": "Public label archive linked" }, "detail": { "zh": "仅对应本页所列 FDA 文件。", "en": "Only the FDA document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国标签档案推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. label archive." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "标签档案能代表现在的产品信息吗？", "en": "Does a label archive represent current product information?" }, "answer": { "zh": "不能自动代表。档案用于定位来源；需要以目标市场的现行官方标签逐项复核。", "en": "Not automatically. The archive locates a source; each point needs verification against the target market’s current official label." } }, { "question": { "zh": "为什么这里不展示价格或原研/仿制结论？", "en": "Why are price and originator/generic conclusions not shown?" }, "answer": { "zh": "这些结论需要产品、剂型、规格、包装、市场、日期和原始记录分别齐全并经人工审核；单一标签文件不足以支持。", "en": "Those conclusions require separately complete and human-reviewed product, dosage-form, strength, pack, market, date and primary-record fields; one label file is insufficient." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/singulair/", "en": "https://origindrug.com/en/drugs/singulair/" }, "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." ] }