{ "id": "zyrtec", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-21", "status": "published_traceable_archive" }, "names": { "brand": "Zyrtec", "generic": "西替利嗪", "aliases": [ "仙特明", "cetirizine", "cetirizine hydrochloride" ], "marketBrandNames": [], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "呼吸系统", "sourceArchiveMarket": "美国 OTC 公开标签档案（当前页面精确对应 10 mg、30 片瓶装纸盒，NDC 50580-726-71）", "dosageFormClass": "口服薄膜衣片（本档案限定为 10 mg 西替利嗪盐酸盐片）", "dosageFormClassCode": "oral_solid", "route": "口服", "routeCode": "oral", "historicalApprovalEntry": "未在本页推定（应按目标市场官方记录核验）", "archiveSponsorText": "DailyMed（NLM）公开标签档案" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [ "ZYRTEC ALLERGY 10 mg Tablets" ], "excludedProductCues": [ "ZYRTEC-D", "ZYRTEC D", "cetirizine pseudoephedrine", "ZYRTEC Chewable", "ZYRTEC oral solution", "ZYRTEC liquid" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-zyrtec-allergy-tablet-10mg-30ct-ndc-50580-726-71", "marketCode": "US", "labelVersion": { "zh": "DailyMed SPL v25；页面 2025-10-10 更新，2025-11-17 发布", "en": "DailyMed SPL v25; page updated 10 Oct 2025 and published 17 Nov 2025" }, "dosageForm": { "zh": "ZYRTEC ALLERGY 盐酸西替利嗪薄膜衣口服片", "en": "ZYRTEC ALLERGY cetirizine hydrochloride film-coated oral tablet" }, "route": { "zh": "口服", "en": "oral" }, "routeCodes": [ "oral" ], "productCode": "NDC 50580-726-71", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_tablet", "primaryDisplay": { "zh": "每片西替利嗪盐酸盐 10 mg；30 片瓶装纸盒", "en": "Cetirizine hydrochloride 10 mg per tablet; 30-tablet bottle carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Zyrtec-1.jpg&setid=b165db38-b302-4220-8627-77cb07bb078c&type=img", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "盐酸西替利嗪", "en": "cetirizine hydrochloride" }, "value": 10, "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": "bottle_carton", "typeLabel": { "zh": "30 片瓶装纸盒", "en": "30-tablet bottle carton" }, "fill": null, "countPerPackage": 30, "countUnit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-21", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 30, "unit": { "zh": "片/瓶装纸盒", "en": "tablets per bottle carton" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "圆角长方形、双凸薄膜衣片", "en": "rounded rectangular biconvex film-coated tablet" }, "imprint": "ZYRTEC / 10 / MG", "scoreStatus": "scored_status_not_a_split_instruction", "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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-zyrtec-allergy-tablet-10mg-30ct-ndc-50580-726-71", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=Zyrtec-1.jpg&setid=b165db38-b302-4220-8627-77cb07bb078c&type=img", "alt": "ZYRTEC ALLERGY 盐酸西替利嗪在美国 DailyMed Kenvue 当前公开标签中的 10 mg、NDC 50580-726-71、30 片瓶装纸盒展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v25（页面 2025-10-10 更新；2025-11-17 发布）", "presentation": "ZYRTEC ALLERGY 盐酸西替利嗪薄膜衣口服片：每片 10 mg，NDC 50580-726-71，30 片瓶装纸盒展示面。", "notice": "此图只对应美国 DailyMed 当前标签中的 ZYRTEC ALLERGY、盐酸西替利嗪 10 mg、NDC 50580-726-71 与 30 片瓶装纸盒。它只帮助核对品牌、通用名、每片标示量、薄膜衣片、包装数量与来源；不用于鉴定真伪，也不证明 ZYRTEC-D、咀嚼片、口服液、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、联用、开始、停用或换药方案。", "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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": "ZYRTEC / 仙特明说明书放大阅读：10 mg 薄膜衣片与其他剂型要分开看", "en": "ZYRTEC label reading: keep the 10 mg film-coated tablet separate from other forms" }, "summary": { "zh": "本模块以美国 DailyMed 公开标签为阅读入口，帮助核对 ZYRTEC、盐酸西替利嗪、每片 10 mg、薄膜衣口服片剂和目标市场。它不提供个人剂量、片数、联用、停用或换药指令。", "en": "This module uses the U.S. DailyMed public label to check ZYRTEC, cetirizine hydrochloride, 10 mg per tablet, film-coated oral-tablet form and target market. It does not provide individual dosing, tablet-count, combination, stopping or switching instructions." }, "checks": [ { "zh": "先把 ZYRTEC、盐酸西替利嗪、每片 10 mg、薄膜衣片和目标市场同时核对。包装上的 10 mg 是该准确片剂的身份字段，不是个人应服几片的网页答案。", "en": "Check ZYRTEC, cetirizine hydrochloride, 10 mg per tablet, film-coated tablet and target market together. The 10 mg on the pack is an identity field for this exact tablet, not a web answer to an individual's tablet count." }, { "zh": "标签提示可能出现嗜睡，并提示酒精、镇静药或安定类药物可能增加嗜睡。若存在这类联用、驾驶/操作机器问题或不适，应带完整药单向药师或医生核对；不要用网页替代个人风险判断。", "en": "The label notes that drowsiness may occur and that alcohol, sedatives or tranquilizers may increase it. With these co-exposures, driving or machinery questions, or symptoms, take the complete medicine list to a pharmacist or clinician rather than using a webpage for individual risk judgement." }, { "zh": "不要因都写“抗过敏”而把本页 ZYRTEC 10 mg 片与 ZYRTEC-D（含伪麻黄碱的复方）、CLARITIN、复方感冒药或其他抗组胺产品自行叠加、隔天轮换或直接替换。共同用途文字不能替代对成分、剂型、市场标签与完整药单的核对。", "en": "Do not self-combine, alternate or directly replace this ZYRTEC 10 mg tablet with ZYRTEC-D (a pseudoephedrine combination), CLARITIN, a combination cold medicine or another antihistamine merely because all mention allergy. Shared use wording does not replace review of ingredients, form, market label and the complete medicine list." }, { "zh": "包装图、刻印或品牌名只可帮助定位来源，不能验证真伪或确定当前批准。肝肾疾病、妊娠哺乳、疑似过敏反应或不确定怎样使用时，应按目标市场现行标签和专业渠道处理。", "en": "Package images, an imprint or a brand name can only help locate a source; they cannot authenticate a product or establish current approval. With liver/kidney disease, pregnancy/breastfeeding, a suspected reaction or uncertainty about use, use the current target-market label and professional channels." } ], "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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": "西替利嗪怎样被标签归类：抗组胺药不等于可自行叠加", "en": "How cetirizine is classified on the label: an antihistamine is not automatically combinable" }, "summary": { "zh": "美国 DailyMed 标签把盐酸西替利嗪标为抗组胺药。该信息用于阅读标签的用途、警示和完整产品身份；它不决定某个人是否适用，或能否与另一种抗过敏、感冒、睡眠或镇静产品同用。", "en": "The U.S. DailyMed label classifies cetirizine hydrochloride as an antihistamine. This helps read the label's use, warning and product-identity information; it does not decide individual suitability or whether another allergy, cold, sleep or sedating product can be used with it." }, "checks": [ { "zh": "药物类别是理解标签的入口，不是症状诊断或自我分诊工具。持续、加重或不明原因的症状应由当地专业渠道判断。", "en": "Drug class is an entry point for understanding a label, not a symptom-diagnosis or self-triage tool. Persistent, worsening or unexplained symptoms need local professional assessment." }, { "zh": "西替利嗪与氯雷他定都可被归入抗组胺药，但共同类别不证明可以同时服用、轮换、把一盒换成另一盒或按毫克数换算。", "en": "Cetirizine and loratadine can both be classed as antihistamines, but a shared class does not prove they can be taken together, alternated, substituted or converted by milligrams." }, { "zh": "标签中的嗜睡与联用警示说明为何完整药单重要；它不是网页把每个人划为“安全”或“不安全”的规则。任何变更应由现行标签和专业人员结合实际产品复核。", "en": "The label's drowsiness and co-use warnings show why a complete medicine list matters; they are not a web rule that sorts every person into “safe” or “unsafe.” Any change needs review of the actual product against the current label with a professional." } ], "source": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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": "Zyrtec", "generic": "西替利嗪", "dosageFormClass": "口服薄膜衣片（本档案限定为 10 mg 西替利嗪盐酸盐片）" }, "labelSource": { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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-2025-cetirizine-zyrtec-pruritus-after-stopping-safety-communication", "issuedAt": "2025-05-16", "status": "fda_drug_safety_communication", "title": { "zh": "FDA 药物安全通讯：停止长期使用口服西替利嗪／Zyrtec 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 cetirizine/Zyrtec" }, "summary": { "zh": "FDA 于 2025-05-16 发布药物安全通讯，说明口服西替利嗪（Zyrtec）或左西替利嗪在长期规律使用后停用，可能出现罕见但可能严重的瘙痒；通讯涉及美国处方与非处方制剂的标签更新。该记录是美国、特定日期和成分／产品线索的监管沟通，不能判断手中任一 Zyrtec 包装、其他抗过敏药、其他市场或任何个人是否会发生此情况，也不支持依据网页自行停药、重新使用、减量或换药。若实际停用后出现严重瘙痒，请尽快联系当地药师、开方团队或医疗服务，并携带实际包装与完整用药清单核对。", "en": "On 2025-05-16, FDA issued a Drug Safety Communication saying that rare but severe itching can occur after stopping long-term, regular use of oral cetirizine (Zyrtec) or levocetirizine; the communication covers U.S. prescription and over-the-counter label updates. This is a dated U.S. regulator communication tied to named ingredients/products. It cannot determine whether any Zyrtec pack, another allergy medicine, another market or any individual will have this outcome, and it does not support self-stopping, restarting, tapering or switching from this page. Severe itching after stopping needs prompt contact with a local pharmacist, prescribing team or medical service, with the actual pack and complete medicine list." }, "source": { "id": "src_72aeda1f7f249ce3", "label": "FDA：2025-05-16 停止长期使用口服西替利嗪／Zyrtec 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": "DailyMed 的 ZYRTEC ALLERGY（cetirizine hydrochloride）美国 OTC 公开标签将本档案所列产品标示为每片 10 mg 的口服薄膜衣片。页面只帮助核对产品身份、标签警示和来源，不推定其他市场的批准、包装、原研关系、供应或可售资格。", "history": "西替利嗪产品可有不同强度、片剂和液体等呈现。名字、相同成分或“24 小时”等包装语言不能证明个人可以自行换算、叠加、替代或改变使用方式。", "sourceDocuments": [ { "id": "src_ca6cef8c5ebbcdf8", "label": "DailyMed（NLM）：ZYRTEC ALLERGY 盐酸西替利嗪 10 mg 薄膜衣片当前美国 OTC 公开标签（Kenvue Brands；SPL v25，2025-11-17 发布）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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": "2025-11", "title": { "zh": "DailyMed 公开标签版本", "en": "DailyMed public label version" }, "detail": { "zh": "本页链接 2025-11 的 DailyMed 美国 OTC 公开标签作为可复核阅读入口。它标识该具体公开标签，不推定初始批准年份、NDA 编号、当前供应、持有人或其他市场状态。", "en": "This page links the 2025-11 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_ca6cef8c5ebbcdf8", "label": "DailyMed: ZYRTEC ALLERGY cetirizine 10 mg current public OTC label", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=b165db38-b302-4220-8627-77cb07bb078c", "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/zyrtec/", "en": "https://origindrug.com/en/drugs/zyrtec/" }, "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." ] }