{ "id": "dulcolax-pink", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-24", "status": "published_traceable_archive" }, "names": { "brand": "DULCOLAX PINK", "generic": "比沙可啶", "aliases": [ "dulcolax", "dulcolax pink", "bisacodyl", "比沙可啶", "41167-0290-5" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 5 mg、25 片泡罩装纸盒，NDC 41167-0290-5）", "dosageFormClass": "包衣缓释口服片（本档案限定为比沙可啶 5 mg 片）", "dosageFormClassCode": "oral_modified_release", "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；Chattem, Inc." }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "DULCOLAX PINK Stimulant Laxative 5 mg Tablets" ], "excludedProductCues": [ "DULCOLAX Soft Chews", "DULCOLAX liquid", "DULCOLAX suppository", "DULCOLAX stool softener", "bisacodyl 10 mg suppository" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-dulcolax-pink-bisacodyl-delayed-release-tablet-5mg-25ct-ndc-41167-0290-5", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v5，2025-02-06 发布", "en": "DailyMed SPL v5, published 6 Feb 2025" }, "dosageForm": { "zh": "DULCOLAX PINK 比沙可啶包衣缓释口服片", "en": "DULCOLAX PINK bisacodyl coated delayed-release oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 41167-0290-5", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片比沙可啶 5 mg；25 片泡罩装纸盒", "en": "Bisacodyl 5 mg per tablet; 25-tablet blister-pack carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dulcolax-pink-stimulant-laxative-01.jpg&setid=fb5ad666-57b3-4b95-b5de-9db5d265925e&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "比沙可啶", "en": "bisacodyl" }, "value": 5, "unit": "mg", "basisCode": "per_tablet", "basisLabel": { "zh": "每片标签标示量；不是个人片数、联用或换药规则", "en": "labelled amount per tablet; not an individual's tablet count, combination or switching rule" } } ], "concentration": null, "container": { "typeCode": "blister_carton", "typeLabel": { "zh": "25 片泡罩装纸盒", "en": "25-tablet blister-pack carton" }, "fill": null, "countPerPackage": 25, "countUnit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-24", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 25, "unit": { "zh": "片/纸盒", "en": "tablets per carton" } }, "physicalClues": { "color": { "zh": "粉红色", "en": "pink" }, "shape": { "zh": "圆形包衣片", "en": "round coated tablet" }, "imprint": "DL", "scoreStatus": "not_scored", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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-dulcolax-pink-bisacodyl-delayed-release-tablet-5mg-25ct-ndc-41167-0290-5", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=dulcolax-pink-stimulant-laxative-01.jpg&setid=fb5ad666-57b3-4b95-b5de-9db5d265925e&type=img", "alt": "DULCOLAX PINK 比沙可啶在美国 DailyMed Chattem 公开标签中的 5 mg、NDC 41167-0290-5、25 片泡罩装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v5（2025-02-06 发布）", "presentation": "DULCOLAX PINK 比沙可啶包衣缓释口服片：每片 5 mg，NDC 41167-0290-5，25 片泡罩装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 DULCOLAX PINK、比沙可啶 5 mg、NDC 41167-0290-5 与 25 片泡罩装纸盒。它只帮助核对品牌、通用名、每片标示量、包衣口服片、包装数量与来源；不用于鉴定真伪，也不证明栓剂、软糖、液体、其他包装、其他市场、当前可得性、原研身份、可替代性，或任何个人的片数、掰分、联用、开始、停用或换药方案。", "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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": "DULCOLAX PINK 说明书放大阅读：5 mg、25 片包装与“不要咀嚼或压碎”须一起看", "en": "DULCOLAX PINK label reading: read 5 mg, the 25-tablet pack and “do not chew or crush” together" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 DULCOLAX PINK、比沙可啶、每片 5 mg、包衣口服片、25 片包装和目标市场。它不提供个人片数、联用、停用、掰分或换药指令。", "en": "This module uses the U.S. DailyMed public label to check DULCOLAX PINK, bisacodyl, 5 mg per tablet, coated oral-tablet form, the 25-tablet pack and target market. It does not provide individual tablet-count, combination, stopping, splitting or switching instructions." }, "checks": [ { "zh": "先将 DULCOLAX PINK、比沙可啶、每片 5 mg、包衣口服片、NDC 41167-0290-5、25 片泡罩装纸盒和目标市场一起核对。5 mg 是这个准确片剂的标签标示量，不是网页给任何人计算片数的答案。", "en": "Check DULCOLAX PINK, bisacodyl, 5 mg per tablet, coated oral-tablet form, NDC 41167-0290-5, the 25-tablet blister-pack carton and target market together. 5 mg is the labelled strength for this exact tablet, not a web answer to anyone's tablet count." }, { "zh": "标签写明不要咀嚼或压碎片剂，并提示不要在服用抗酸药或牛奶后一小时内使用。此类文字是实际产品标签的阅读重点，不是网站给任何人的时间表、食物规则或替换方案。", "en": "The label says not to chew or crush the tablets and cautions against use within one hour after an antacid or milk. These are key reading points from the label for the actual product, not a website timetable, food rule or substitution plan for anyone." }, { "zh": "标签提示腹痛、恶心或呕吐、排便习惯突变超过两周、直肠出血、使用后仍未排便或需要使用通便药超过一周时，应按标签联系医生或药师。不要把这些警示改造成网页上的自行加量、继续、停药、联用或换药步骤。", "en": "The label directs readers with stomach pain, nausea or vomiting, a bowel-habit change lasting over two weeks, rectal bleeding, no bowel movement after use or a need for a laxative over one week to contact a clinician or pharmacist through the label. Do not turn these warnings into self-directed increase, continuation, stopping, combination or switching steps from a webpage." }, { "zh": "名称、粉红色外观、DL 刻印或包装图只能帮助定位来源，不能鉴定真伪、证明当前批准或决定个人是否适用。严重腹痛、晕厥、持续呕吐、出血或其他急性不适时，应优先使用当地紧急医疗支持。", "en": "The name, pink appearance, DL imprint or package image can only help locate a source; they cannot authenticate a product, establish current approval or decide individual suitability. With severe abdominal pain, fainting, persistent vomiting, bleeding or another acute problem, prioritise local emergency medical support." } ], "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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": "比沙可啶怎样被标签识别：刺激性通便药类别不等于可自行调整", "en": "How the label identifies bisacodyl: a stimulant-laxative class is not a self-adjustment rule" }, "summary": { "zh": "美国 DailyMed 标签将 DULCOLAX PINK 标为刺激性通便药。这个类别帮助读者找到准确产品、用途与警示；它不决定便秘的原因、个人是否适用，或能否与另一种通便、止泻、止痛、减重或处方产品一起使用。", "en": "The U.S. DailyMed label identifies DULCOLAX PINK as a stimulant laxative. This class helps readers locate the exact product, use and warnings; it does not determine the cause of constipation, individual suitability or whether another bowel medicine, pain, weight-loss or prescription product can be used with it." }, "checks": [ { "zh": "“刺激性通便药”是标签类别线索，不是便秘病因诊断或自我分诊工具。突发、持续、加重或伴随出血、腹痛、呕吐等情况需要当地专业渠道判断。", "en": "“Stimulant laxative” is a label-class clue, not a diagnosis of why constipation occurs or a self-triage tool. Sudden, persistent, worsening symptoms or symptoms with bleeding, abdominal pain or vomiting need assessment through local professional channels." }, { "zh": "同一类别、同一品牌或相同 5 mg 数字不表示不同片剂、栓剂、液体、软糖、复方、不同市场包装或另一种通便产品可以自行叠加、轮换、替代或按半片/毫升换算。", "en": "A shared class, brand name or 5 mg number does not make different tablets, suppositories, liquids, chews, combinations, market packs or another laxative self-combinable, alternatable, substitutable or convertible by half-tablet or millilitres." }, { "zh": "标签的缓释片剂、不要咀嚼/压碎与抗酸药提示说明，完整药单、饮食/非处方产品和实际包装需要一起核对；它不是网页把任何人划为“安全”或“不安全”的规则。", "en": "The label's delayed-release tablet, do-not-chew/crush and antacid cues show why the complete medicine list, food/OTC products and actual pack need review together; they are not a web rule that sorts anyone into “safe” or “unsafe.”" } ], "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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": "DULCOLAX PINK", "generic": "比沙可啶", "dosageFormClass": "包衣缓释口服片（本档案限定为比沙可啶 5 mg 片）" }, "labelSource": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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": [], "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 DULCOLAX PINK（bisacodyl）美国 OTC 公开标签将本档案所列产品标示为每片 5 mg 的包衣口服片。页面帮助阅读品牌、通用名、每片强度、准确包装与美国标签范围；不据此推定中国大陆或其他市场的批准、包装、持有人、原研关系、供应或可售资格。", "history": "“隔夜”“缓释”“5 mg”和粉红色外观是这一准确产品的标签与外观线索，不是网页上的个人片数、间隔、掰分、联用、停用或换药规则。栓剂、软糖、液体或其他通便产品须逐项重新核对。", "sourceDocuments": [ { "id": "src_f72dd27a009ad0e6", "label": "DailyMed（NLM）：DULCOLAX PINK 比沙可啶 5 mg 当前美国 OTC 公开标签（Chattem；SPL v5，2025-02-06 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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": "DailyMed U.S. OTC label record", "approvalTimeline": [ { "date": "DailyMed SPL v5, published 2025-02-06", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 DailyMed SPL v5, published 2025-02-06 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the DailyMed SPL v5, published 2025-02-06 DailyMed U.S. OTC public label as a traceable reading entry point. It identifies that specific public label and does not assert an original-approval year, NDA number, current availability, holder or another-market status." }, "source": { "id": "src_f72dd27a009ad0e6", "label": "DailyMed: DULCOLAX PINK bisacodyl current U.S. OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=fb5ad666-57b3-4b95-b5de-9db5d265925e", "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 OTC 公开标签", "en": "OTC public label linked" }, "detail": { "zh": "仅对应本页所列 DailyMed OTC 文件。", "en": "Only the DailyMed OTC document listed on this page is linked." } }, { "market": { "zh": "中国大陆、欧盟、日本", "en": "Mainland China, EU, Japan" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "不从美国 OTC 标签推定当地批准、持有人、规格、供应或可售资格。", "en": "No local approval, holder, strength, supply or sale-eligibility conclusion is inferred from the U.S. OTC label." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "美国 OTC 标签能代表其他市场或个人用法吗？", "en": "Does a U.S. OTC label represent another market or personal use?" }, "answer": { "zh": "不能。它仅是这一具体美国公开标签的阅读入口；目标市场的现行文件和个人情况必须分别由专业人员核对。", "en": "No. It is only a reading entry point for this specific U.S. public label; the current target-market document and individual circumstances need separate professional review." } }, { "question": { "zh": "为什么不把 OTC 档案写成原始批准或原研结论？", "en": "Why does the OTC archive not state original approval or originator conclusions?" }, "answer": { "zh": "标签记录不足以证明这些结论。它们需要可追溯的产品、剂型、市场、时间和一手监管记录，并经人工审核。", "en": "A label record is insufficient to prove those conclusions. They require traceable product, dosage-form, market, date and primary regulatory records with human review." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "how-to-read-a-drug-label", "regulatory-sources-first" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/dulcolax-pink/", "en": "https://origindrug.com/en/drugs/dulcolax-pink/" }, "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." ] }