{ "id": "miralax", "recordTier": "source_traceable_archive", "editorial": { "reviewedAt": "2026-08-29", "status": "published_traceable_archive" }, "names": { "brand": "MiraLAX", "generic": "聚乙二醇 3350", "aliases": [ "MIRALAX", "Miralax", "polyethylene glycol 3350", "PEG 3350", "PEG3350", "聚乙二醇 3350", "聚乙二醇3350散", "聚乙二醇 3350 粉末", "NDA 022015", "11523-7268-3", "11523-7268-9", "11523-7234-4", "11523-4357-3" ], "marketBrandNames": [ { "name": "MiraLAX", "market": { "zh": "美国", "en": "United States" }, "evidenceStatus": "current_regulatory_record", "note": { "zh": "FDA 当前列示 17 g/标线量盖与 17 g/袋两个 RLD/RS OTC 产品；准确包装仍须按 NDC 和当前标签核对。", "en": "FDA currently lists 17 g per marked-cap fill and 17 g per packet as RLD/RS OTC products; exact packs still require NDC and current-label checking." }, "source": { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "mainlandChinaTradeNameCue": null }, "identity": { "therapeuticArea": "消化系统", "sourceArchiveMarket": "美国：FDA Drugs@FDA 将 MiraLAX、NDA 022015、聚乙二醇 3350 17 g/标线量盖和 17 g/袋相连，当前列为 OTC、RLD Yes、RS Yes；DailyMed SPL v24 于 2026-05-04 生效并列出 Bayer 当前标签、NDC 与包装面板。标签或 RLD 状态不证明任何地点有库存、可购买、适合个人或与其他产品可自动互换。", "dosageFormClass": "不含辅料的聚乙二醇 3350 口服溶液用白色粉末；瓶装用原瓶标线量盖核对 17 g，独立袋每袋 17 g。克（g）、毫克（mg）、瓶内总克数、包装所写次数和个人用法必须分开理解", "dosageFormClassCode": "oral_solid", "route": "先完全溶解后口服", "routeCode": "oral", "historicalApprovalEntry": "1999（美国处方产品）；2006-10-06（美国 OTC 转换批准）", "archiveSponsorText": "Bayer HealthCare LLC（FDA 当前 NDA 与 DailyMed 标签主体）；Braintree Laboratories, Inc. 为历史开发／申请主体" }, "matchPolicy": { "contract": "reviewed_name_and_exclusion_cues_v1", "exactMatchNames": [], "excludedProductCues": [ "MiraLAX Orange", "MiraFAST", "MiraSOFT", "MiraFIBER", "MiraGUT", "polyethylene glycol electrolyte solution", "PEG electrolyte bowel preparation", "含电解质聚乙二醇肠道清洁剂", "generic polyethylene glycol 3350", "其他厂牌聚乙二醇 3350" ], "exclusionPrecedence": "before_name_candidate" }, "productPresentations": [ { "id": "us-miralax-polyethylene-glycol-3350-17g-10-packet-carton-ndc-1152372683", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末独立袋", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution packet" }, "route": { "zh": "先完全溶解后口服（准确包装身份字段）", "en": "oral after complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-7268-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋聚乙二醇 3350 17 g；10 袋纸盒", "en": "Polyethylene glycol 3350 17 g per packet; 10-packet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011253_MIRALAX_RESTORALAX_MiralaxPowder_10ct_Carton_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标签标示量；17 g 等于 17,000 mg，但这不是个人频率、疗程或加量指令", "en": "labelled amount per packet; 17 g equals 17,000 mg, but this is not an individual's frequency, course or increase instruction" } } ], "concentration": null, "container": { "typeCode": "carton_packets", "typeLabel": { "zh": "独立袋纸盒", "en": "packet carton" }, "fill": null, "countPerPackage": 10, "countUnit": { "zh": "袋/盒", "en": "packets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 10, "unit": { "zh": "袋/盒", "en": "packets per carton" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "每袋净含量 17 g 的粉末，不是片剂或胶囊", "en": "17 g powder packet, not a tablet or capsule" }, "imprint": "MiraLAX Mix-In Pax 10", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-miralax-polyethylene-glycol-3350-17g-20-packet-carton-ndc-1152372689", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末独立袋", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution packet" }, "route": { "zh": "先完全溶解后口服（准确包装身份字段）", "en": "oral after complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-7268-9", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_packet", "primaryDisplay": { "zh": "每袋聚乙二醇 3350 17 g；20 袋纸盒", "en": "Polyethylene glycol 3350 17 g per packet; 20-packet carton" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011256_MIRALAX_RESTORALAX_MiralaxPowder_20ct_Carton_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_packet", "basisLabel": { "zh": "每袋标签标示量；17 g 等于 17,000 mg，但这不是个人频率、疗程或加量指令", "en": "labelled amount per packet; 17 g equals 17,000 mg, but this is not an individual's frequency, course or increase instruction" } } ], "concentration": null, "container": { "typeCode": "carton_packets", "typeLabel": { "zh": "独立袋纸盒", "en": "packet carton" }, "fill": null, "countPerPackage": 20, "countUnit": { "zh": "袋/盒", "en": "packets per carton" } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 20, "unit": { "zh": "袋/盒", "en": "packets per carton" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "每袋净含量 17 g 的粉末，不是片剂或胶囊", "en": "17 g powder packet, not a tablet or capsule" }, "imprint": "MiraLAX Mix-In Pax 20", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-miralax-polyethylene-glycol-3350-510g-30-marked-cap-fills-1-bottle-pack-ndc-1152372344", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末瓶装", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution bottle" }, "route": { "zh": "用原瓶标线量盖量取、完全溶解后口服（准确包装身份字段）", "en": "oral after measuring with the marked original cap and complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-7234-4", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_marked_cap_fill", "primaryDisplay": { "zh": "每次量到原瓶量盖标线为聚乙二醇 3350 17 g；510 g 瓶装；标签称约 30 个标线量", "en": "Polyethylene glycol 3350 17 g per fill to the original cap line; 510 g bottle; label describes about 30 marked-cap fills" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011297_MIRALAX_510+Gram_30Dose_FrontLabel.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_marked_cap_fill", "basisLabel": { "zh": "装至原瓶量盖标线的标签标示量；瓶内总克数、包装所写次数和个人用法不是同一字段", "en": "labelled amount when filled to the original cap line; total bottle grams, pack dose count and individual use are different fields" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "带标线量盖的瓶", "en": "bottle with marked measuring cap" }, "fill": { "value": 510, "unit": "g" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 1, "unit": { "zh": "瓶；总量 510 g", "en": "bottle; 510 g total" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "瓶装粉末和带标线量盖，不是片剂、胶囊或普通勺", "en": "bottled powder with a marked cap, not a tablet, capsule or kitchen spoon" }, "imprint": "MiraLAX 30 doses", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-miralax-polyethylene-glycol-3350-578g-34-marked-cap-fills-2-bottle-pack-ndc-1152343573", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "en": "Current U.S. DailyMed OTC label (SPL v24; effective 4 May 2026)" }, "dosageForm": { "zh": "MiraLAX 聚乙二醇 3350 口服溶液用粉末瓶装", "en": "MiraLAX polyethylene glycol 3350 powder-for-oral-solution bottle" }, "route": { "zh": "用原瓶标线量盖量取、完全溶解后口服（准确包装身份字段）", "en": "oral after measuring with the marked original cap and complete dissolution (exact package-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 11523-4357-3", "pouchCode": null, "applicationNumber": null, "presentationRole": null, "primaryStrengthBasisCode": "per_marked_cap_fill", "primaryDisplay": { "zh": "每次量到原瓶量盖标线为聚乙二醇 3350 17 g；双瓶装，每瓶 578 g；标签称约 34 个标线量", "en": "Polyethylene glycol 3350 17 g per fill to the original cap line; two bottles, 578 g each; label describes about 34 marked-cap fills" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011325_MIRALAX_RESTORALAX_34Dose_FrontLabel_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "聚乙二醇 3350", "en": "polyethylene glycol 3350" }, "value": 17, "unit": "g", "basisCode": "per_marked_cap_fill", "basisLabel": { "zh": "装至原瓶量盖标线的标签标示量；瓶内总克数、包装所写次数和个人用法不是同一字段", "en": "labelled amount when filled to the original cap line; total bottle grams, pack dose count and individual use are different fields" } } ], "concentration": null, "container": { "typeCode": "twin_bottle_pack", "typeLabel": { "zh": "双瓶组合装", "en": "twin-bottle pack" }, "fill": { "value": 578, "unit": "g" }, "countPerPackage": null, "countUnit": null }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-08-29", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 2, "unit": { "zh": "瓶/组合装；每瓶 578 g", "en": "bottles per pack; 578 g each" } }, "physicalClues": { "color": { "zh": "白色粉末；溶解后无色", "en": "white powder; colourless after dissolution" }, "shape": { "zh": "瓶装粉末和带标线量盖，不是片剂、胶囊或普通勺", "en": "bottled powder with a marked cap, not a tablet, capsule or kitchen spoon" }, "imprint": "MiraLAX 34 doses", "scoreStatus": null, "patchAreaCm2": null }, "comparisonNotice": null, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "comparisonPresentations": [], "appearanceReferences": [], "visualReference": { "presentationId": "us-miralax-polyethylene-glycol-3350-17g-20-packet-carton-ndc-1152372689", "status": "historical_public_label_image_not_product_authentication", "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=C00011256_MIRALAX_RESTORALAX_MiralaxPowder_20ct_Carton_r1_clean.jpg&setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "alt": "MiraLAX 聚乙二醇 3350、每袋 17 g、20 袋纸盒的美国 DailyMed 官方标签展示面", "archiveMarket": "美国", "labelVersion": "DailyMed SPL v24；2026-05-04 生效", "presentation": "MiraLAX Mix-In Pax 聚乙二醇 3350，每袋 17 g，20 袋纸盒，NDC 11523-7268-9。", "notice": "此图只对应所引 DailyMed 当前标签中的 20 袋纸盒，不代表 10 袋纸盒、瓶装、双瓶装、橙味、其他 Mira 品牌家族、其他厂牌聚乙二醇 3350、其他市场包装或实时供应；不用于鉴定真伪，也不生成个人频率或疗程。", "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "MiraLAX 说明书放大阅读：先分清 17 g、17,000 mg、每袋、量盖标线和瓶内总量", "en": "MiraLAX label reading: separate 17 g, 17,000 mg, per packet, the cap line and total bottle contents" }, "summary": { "zh": "当前美国 OTC 标签把每袋 17 g 和原瓶量盖装至标线 17 g 分开写明。网页放大单位、包装、完全溶解和警示信息；它不替任何人决定是否使用、使用频率、持续时间或儿童用法。", "en": "The current U.S. OTC label separately states 17 g per packet and 17 g when the original bottle cap is filled to its line. The site enlarges units, package identity, complete dissolution and warnings; it does not decide individual use, frequency, duration or paediatric use." }, "checks": [ { "zh": "1 g 等于 1,000 mg，所以 17 g 等于 17,000 mg。这只是单位换算，不表示把其他粉末、勺子或药物按 17,000 mg 自行替代，也不表示每个人的频率和疗程。", "en": "One gram equals 1,000 milligrams, so 17 g equals 17,000 mg. This is only a unit conversion; it does not make another powder, spoon or medicine self-substitutable at 17,000 mg, or determine anyone's frequency or duration." }, { "zh": "独立袋是每袋 17 g；瓶装须使用随原瓶提供、带白色标线的量盖。普通厨房勺、其他药瓶量盖、肉眼分粉或电子秤未经产品标签确认，不能当作相同的准确产品量具。", "en": "Each packet contains 17 g; the bottle uses its supplied cap with the marked white line. A kitchen spoon, another medicine's cap, visual powder splitting or an unvalidated scale is not the same labelled product measure." }, { "zh": "标签要求粉末在饮料中完全搅拌溶解，不要在仍有结块时饮用；并明确不要与用于吞咽困难的淀粉类增稠剂混合。吞咽困难者应让药师或临床团队核对安全的具体方案。", "en": "The label says to stir until fully dissolved and not drink while clumps remain; it also says not to combine with starch-based thickeners used for swallowing difficulty. A person with dysphagia needs a pharmacist or clinical team to review the specific safe plan." }, { "zh": "肾病、恶心、呕吐、腹痛、持续两周以上的排便习惯突然变化或肠易激综合征，及同时使用处方药，都属于标签要求先咨询医生或药师的情形。网页不能从年龄或症状判断个人适用性。", "en": "Kidney disease, nausea, vomiting, abdominal pain, a sudden bowel-habit change lasting over two weeks, irritable bowel syndrome, or taking a prescription medicine are label reasons to ask a doctor or pharmacist first. The site cannot decide individual suitability from age or symptoms." }, { "zh": "直肠出血，腹痛、腹胀或痉挛加重，出现腹泻，或需要使用泻药超过一周，应停止自行延长并尽快寻求专业评估。严重腹痛、持续呕吐、明显腹胀、不能排气排便、晕厥或严重脱水可能需要急救。", "en": "Rectal bleeding, worsening abdominal pain, bloating or cramping, diarrhoea, or needing a laxative beyond one week are reasons not to self-extend use and to seek professional assessment. Severe pain, persistent vomiting, marked distension, inability to pass gas or stool, fainting or severe dehydration may require emergency care." }, { "zh": "聚乙二醇电解质肠道清洁液、橙味产品、MiraFAST、MiraSOFT、其他 Mira 品牌家族和其他厂牌 PEG 3350 不是本档案四个准确包装。不要只凭‘聚乙二醇’或紫色包装就自行替换。", "en": "PEG-electrolyte bowel preparations, orange-flavour products, MiraFAST, MiraSOFT, other Mira-family products and other PEG 3350 brands are not the four exact packs in this dossier. Do not self-substitute from ‘polyethylene glycol’ or purple packaging alone." } ], "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "聚乙二醇 3350 怎样起作用：渗透性保留水分，不等于所有便秘都适合自行处理", "en": "How polyethylene glycol 3350 works: osmotic water retention does not make every constipation problem suitable for self-care" }, "summary": { "zh": "FDA 历史审评资料将 PEG 3350 描述为不易吸收、具有渗透活性的物质，通过在肠道内容物中保留水分帮助增加粪便含水量。机制可以解释‘渗透性泻药’，但不能诊断便秘原因、排除梗阻或决定个人频率和持续时间。", "en": "The FDA historical review describes PEG 3350 as a poorly absorbed, osmotically active substance that retains water in intestinal contents and increases stool water. This explains an osmotic laxative, but cannot diagnose the cause of constipation, exclude obstruction or determine individual frequency and duration." }, "checks": [ { "zh": "长期卧床、脱水、饮食变化、活动减少、疾病和多种药物都可能与便秘有关。老人同时使用阿片类止痛药、抗胆碱药、铁剂、钙剂或其他药时，应把完整药单交给药师或医生核对，而不是只叠加泻药。", "en": "Bed rest, dehydration, diet change, reduced activity, illness and many medicines can contribute to constipation. An older person using opioids, anticholinergics, iron, calcium or other medicines should have the complete list reviewed rather than simply adding laxatives." }, { "zh": "‘渗透性’不表示可以与比沙可啶、番泻叶、乳果糖、镁盐或其他便秘产品自行叠加、轮换或按克数换算。成分、起效方式、警示和肾功能边界不同。", "en": "‘Osmotic’ does not permit self-combination, alternation or gram conversion with bisacodyl, senna, lactulose, magnesium salts or another constipation product. Ingredients, onset, warnings and renal boundaries differ." }, { "zh": "若怀疑粪便嵌塞、肠梗阻、严重脱水或药物不良反应，作用机制不能替代检查。持续或严重症状应使用当地医疗服务，严重时立即急救。", "en": "If impaction, obstruction, severe dehydration or an adverse drug effect is suspected, a mechanism cannot replace examination. Persistent or severe symptoms need local medical care and emergency help when serious." } ], "source": { "id": "src_6c8c24b9ba0dee95", "label": "FDA：MiraLAX NDA 022015 Rx-to-OTC 审评资料（2006；历史药理与产品背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "MiraLAX", "generic": "聚乙二醇 3350", "dosageFormClass": "不含辅料的聚乙二醇 3350 口服溶液用白色粉末；瓶装用原瓶标线量盖核对 17 g，独立袋每袋 17 g。克（g）、毫克（mg）、瓶内总克数、包装所写次数和个人用法必须分开理解" }, "labelSource": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "productRoutes": [ { "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "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": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, { "source": { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, "status": "product_level_public_record_verified", "authority": { "zh": "FDA", "en": "FDA" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "监管产品记录或标签档案", "en": "Regulatory product record or label archive" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } } ], "recordRoute": { "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-08-29", "scope": { "zh": "已逐项核对本档案可公开访问的产品级来源入口。该核对不代表已完成所有国家或地区的实时警示检索，也不代表该药存在或不存在当前风险。", "en": "This dossier’s publicly accessible product-level route has been checked individually. It does not mean that real-time alerts in every country or region have been searched, or that the medicine has or does not have a current risk." } }, "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": "MiraLAX 是聚乙二醇 3350 口服溶液用粉末品牌档案。最容易看错的不是商品名，而是单位与量具：每袋是 17 g；瓶装标签把原瓶量盖加到标线作为 17 g。17 g 等于 17,000 mg，但瓶内总克数、包装所写‘多少次’与某个人应该如何使用不是一回事。页面帮助核对准确包装、完全溶解、肾病/腹痛/出血/腹泻和完整药单，不生成个人次数或疗程。", "history": "FDA 审评资料记录处方 MiraLAX（NDA 020698）于 1999-02-18 批准；Drugs@FDA 记录 NDA 022015 于 2006-10-06完成部分 Rx-to-OTC 转换批准。当前 Drugs@FDA 将 17 g/标线量盖与 17 g/袋列为 OTC、RLD 与 RS；DailyMed 当前 SPL v24 于 2026-05-04 生效。历史与当前文件不能被改写成实时库存或个人用药结论。", "sourceDocuments": [ { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_6c8c24b9ba0dee95", "label": "FDA：MiraLAX NDA 022015 Rx-to-OTC 审评资料（2006；历史药理与产品背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } ], "applicationNumber": "FDA NDA 022015（MiraLAX polyethylene glycol 3350 powder for oral solution）", "approvalTimeline": [ { "date": "1999-02-18", "title": { "zh": "处方 MiraLAX 美国批准历史", "en": "Prescription MiraLAX U.S. approval history" }, "detail": { "zh": "FDA 2006 审评资料记录处方 MiraLAX NDA 020698 于 1999-02-18 批准。该历史节点不代表当前处方状态或包装。", "en": "The FDA 2006 review records approval of prescription MiraLAX NDA 020698 on 18 Feb 1999. This historical point does not establish current prescription status or packaging." }, "source": { "id": "src_6c8c24b9ba0dee95", "label": "FDA：MiraLAX NDA 022015 Rx-to-OTC 审评资料（2006；历史药理与产品背景）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/nda/2006/022015s000_MedR_Part3.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "regulatory_review", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_pdf", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2006-10-06", "title": { "zh": "NDA 022015 Rx-to-OTC 转换批准", "en": "NDA 022015 Rx-to-OTC switch approved" }, "detail": { "zh": "Drugs@FDA 将该日列为 Type 8 部分 Rx-to-OTC 转换批准，并将 17 g/标线量盖与 17 g/袋列为 MiraLAX 产品。", "en": "Drugs@FDA lists a Type 8 partial Rx-to-OTC switch approval on this date and records MiraLAX 17 g per marked-cap fill and 17 g per packet products." }, "source": { "id": "src_22a857a6b43afae2", "label": "FDA Drugs@FDA：MiraLAX NDA 022015 当前产品、RLD 与批准历史", "url": "https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=022015", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_database_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } }, { "date": "2026-05-04", "title": { "zh": "DailyMed 当前 SPL v24 生效", "en": "Current DailyMed SPL v24 effective" }, "detail": { "zh": "当前 Bayer 标签列出 Drug Facts、量盖和独立袋说明、包装 NDC、警示及官方展示面。文件日期定位标签版本，不是个人开始使用日期。", "en": "The current Bayer label lists Drug Facts, cap and packet directions, package NDCs, warnings and official panels. The date identifies the label version, not an individual's start date." }, "source": { "id": "src_f77fb16bcc208dcf", "label": "DailyMed（NLM）：MiraLAX 聚乙二醇 3350 当前美国 OTC 标签（SPL v24；2026-05-04 生效）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=d69ce3d4-7ca4-4fe3-b49e-6655e48d6963", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" } } ], "marketStatus": [ { "market": { "zh": "美国", "en": "United States" }, "status": { "zh": "当前 OTC、RLD/RS；四个准确包装展示身份已建立", "en": "Current OTC RLD/RS; four exact displayed package identities established" }, "detail": { "zh": "页面记录每袋 17 g、标线量盖 17 g、包装数量、瓶内总克数和 NDC；这些字段不证明当地库存、个人适用性或其他 PEG 产品可自动替代。", "en": "The page records 17 g per packet, 17 g per marked cap, pack count, total bottle grams and NDC. These fields do not establish local stock, individual suitability or automatic substitution with another PEG product." } }, { "market": { "zh": "中国大陆及其他市场", "en": "Mainland China and other markets" }, "status": { "zh": "待逐项建立现行市场记录", "en": "Current market record not established" }, "detail": { "zh": "不从美国 MiraLAX 名称、PEG 3350 成分或包装颜色推定当地批准、商品名、包装、供应、原研/仿制关系或可替代性。", "en": "No local approval, trade name, pack, supply, originator/generic relationship or interchangeability is inferred from the U.S. MiraLAX name, PEG 3350 ingredient or pack colour." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "17 g 是不是 17 mg？瓶上 510 g 又是什么意思？", "en": "Is 17 g the same as 17 mg, and what does 510 g on a bottle mean?" }, "answer": { "zh": "不是。17 g 等于 17,000 mg，是每袋或原瓶量盖加到标线时的标签标示量；510 g 是该瓶粉末的总净含量。单位换算和包装总量都不能替个人决定频率或疗程。", "en": "No. 17 g equals 17,000 mg and is the labelled amount per packet or per fill to the original cap line; 510 g is the bottle's total net powder content. Neither unit conversion nor total pack content determines individual frequency or duration." } }, { "question": { "zh": "家里没有原量盖，可以用普通勺子或把粉分一半吗？", "en": "Can a kitchen spoon or visual half be used if the original cap is missing?" }, "answer": { "zh": "不要自行假定等量。当前标签只核验原瓶带标线量盖和独立 17 g 袋。请带产品和包装让药师帮助确认合适的替代量具或产品；网页不从勺子外观计算克数。", "en": "Do not assume equivalence. The current label verifies only the marked original cap and individual 17 g packets. Take the product and pack to a pharmacist to confirm an appropriate measure or product; the site does not calculate grams from spoon appearance." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "medicine-label-for-everyday-questions", "dose-units-and-concentrations", "polypharmacy-safety-guide" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/miralax/", "en": "https://origindrug.com/en/drugs/miralax/" }, "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." ] }