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Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-250mg-500-count-ndc-8196422505", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-225-05", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 250 mg；500 粒瓶装", "en": "Amoxicillin 250 mg per capsule; 500-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-250mg-500s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 250, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 250", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-100-count-ndc-8196420501", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-01", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；100 粒瓶装", "en": "Amoxicillin 500 mg per capsule; 100-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-100s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-500-count-ndc-8196420505", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-05", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；500 粒瓶装", "en": "Amoxicillin 500 mg per capsule; 500-capsule bottle" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-500s.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "瓶装", "en": "bottle" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 500, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-100-count-ndc-8196420510", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-10", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；100 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 100-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-100cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-60-count-ndc-8196420560", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-205-60", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；60 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 60-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-60cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "粉红色与宝蓝色", "en": "pink and royal blue" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-100-count-ndc-8196435010", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-350-10", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；100 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 100-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-white-100cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 100, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" }, { "id": "us-amoxicillin-anda-062216-capsule-500mg-60-count-ndc-8196435060", "marketCode": "US", "labelVersion": { "zh": "DailyMed 当前 AMOXICILLIN ANDA 062216 公开标签；2026-09-02 复核", "en": "Current DailyMed AMOXICILLIN ANDA 062216 public label; reviewed 2 Sep 2026" }, "dosageForm": { "zh": "AMOXICILLIN 阿莫西林口服胶囊（独立 ANDA 产品）", "en": "AMOXICILLIN amoxicillin oral capsule (separate ANDA product)" }, "route": { "zh": "口服（标签产品身份字段）", "en": "oral (label product-identity field)" }, "routeCodes": [ "oral" ], "productCode": "NDC 81964-350-60", "pouchCode": null, "applicationNumber": "ANDA 062216", "presentationRole": "separate_current_anda_comparator_not_amoxil_nda_brand_pack", "primaryStrengthBasisCode": "per_capsule", "primaryDisplay": { "zh": "每粒阿莫西林 500 mg；60 粒瓶装（防儿童开启瓶盖）", "en": "Amoxicillin 500 mg per capsule; 60-capsule bottle with child-resistant closure" }, "imageUrl": "https://dailymed.nlm.nih.gov/dailymed/image.cfm?name=label-500mg-white-60cr.jpg&setid=110ba6b1-f175-48a1-8e30-616c02212538", "visualStatus": "exact_public_label_package_image", "labeledQuantities": [ { "ingredient": { "zh": "阿莫西林", "en": "amoxicillin" }, "value": 500, "unit": "mg", "basisCode": "per_capsule", "basisLabel": { "zh": "每粒标签标示量；不是个人粒数、频率、疗程或剂型转换指令", "en": "labelled amount per capsule; not an individual's capsule count, frequency, course or dosage-form conversion instruction" } } ], "concentration": null, "container": { "typeCode": "bottle", "typeLabel": { "zh": "防儿童开启瓶装", "en": "bottle with child-resistant closure" }, "fill": null, "countPerPackage": 1, "countUnit": { "zh": "瓶/包", "en": "bottle per pack" }, "unitsPerContainer": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } } }, "deliveryDevice": null, "compatibleReusableDevice": null, "listingStatus": { "reviewedAt": "2026-09-02", "currentLabelDisplayed": true, "ndcDirectoryListed": true, "marketAvailability": "not_established", "marketingStartDate": null, "marketingEndDate": null, "purpleBookPresentationStatus": null, "statusConflictRequiresManualReview": false }, "package": { "count": 60, "unit": { "zh": "粒/瓶", "en": "capsules per bottle" } }, "physicalClues": { "color": { "zh": "白色", "en": "white" }, "shape": { "zh": "胶囊；无刻痕", "en": "capsule; unscored" }, "imprint": "AMOXIL / 500", "scoreStatus": "unscored", "patchAreaCm2": null }, "comparisonNotice": { "zh": "这是美国 ANDA 062216 当前公开标签中的精确包装图。胶囊虽印有 AMOXIL 字样，但本卡不是 AMOXIL NDA 品牌包装、原研身份、其他市场产品、真伪鉴定或当前有货证明。", "en": "This is an exact package panel in the current U.S. ANDA 062216 public label. Although the capsule bears an AMOXIL imprint, this card is not an AMOXIL NDA brand pack, originator-status, another-market product, authentication or current-availability claim." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：AMOXICILLIN 胶囊当前美国 ANDA 062216 公开标签（USAntibiotics）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "scope": "package_and_label_identity_only_not_personal_dosing_or_conversion" } ], "appearanceReferences": [], "visualReference": { "status": "withheld_repackaged_or_non_exact_visual", "title": { "zh": "已核验 AMOXIL 四个 NDA 的品牌标签，但未保留可与单一原品牌包装一一对应的官方图片，故不展示包装图", "en": "The AMOXIL brand label for four NDAs was reviewed, but no official image matching one exact original-brand pack was retained, so no package visual is shown" }, "summary": { "zh": "FDA 2024 品牌标签提供片剂、混悬液和咀嚼片的强度、NDC、包装与外观文字，但此次未保留可安全公开展示且与单一 AMOXIL NDA 包装准确对应的官方图片。先前使用的 250/500 mg 胶囊图片来自另一份 AMOXICILLIN ANDA 标签，不能再作为 AMOXIL 原品牌外观。为避免误导，页面以八张标签文字身份卡代替包装图，并保留 ANDA 对照来源供核验。", "en": "The 2024 FDA brand label provides strengths, NDCs, packaging and appearance text for tablets, suspension and chewables, but no official image was retained that can safely be displayed and matched to one exact AMOXIL NDA pack. The previously used 250/500 mg capsule images come from a different AMOXICILLIN ANDA label and cannot serve as AMOXIL original-brand appearance. To prevent confusion, the page uses eight source-text identity cards and retains the ANDA comparator source for verification." }, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, "visualCoverageNote": null, "labelReading": { "coverage": "drug_specific_source_review", "title": { "zh": "AMOXIL 说明书放大阅读：先分清 NDA 品牌剂型，再看另一份 ANDA 通用名标签", "en": "AMOXIL label reading: separate the NDA brand forms from a different ANDA generic label" }, "summary": { "zh": "FDA 2024 AMOXIL 品牌标签列的是 500/875 mg 片、200/400 mg 每 5 mL 复溶后混悬液和 125/200/250/400 mg 咀嚼片；当前 DailyMed 的 250/500 mg 胶囊及 125/250 mg 每 5 mL 混悬液属于另一份 AMOXICILLIN ANDA 标签，不能合并成 AMOXIL 原研包装。", "en": "The 2024 FDA AMOXIL brand label lists 500/875 mg tablets, 200/400 mg per 5 mL suspension after reconstitution, and 125/200/250/400 mg chewables. The current DailyMed 250/500 mg capsules and 125/250 mg per 5 mL suspension belong to a different AMOXICILLIN ANDA label and cannot be merged into the AMOXIL NDA brand pack." }, "checks": [ { "zh": "“500 mg/片”和“400 mg/5 mL”是两种不同剂型的标签单位。包装数字不能回答个人该吃几片或几毫升；诊断、年龄或体重、肾功能、准确产品、处方和目标市场标签缺一不可。", "en": "‘500 mg per tablet’ and ‘400 mg per 5 mL’ are label units for different forms. Pack numbers cannot answer how many tablets or millilitres an individual should take; diagnosis, age or weight, kidney function, exact product, prescription and target-market label are all required." }, { "zh": "875 mg 片有刻痕是该标签产品的外观身份，不是自行掰半、减量或替换其他规格的许可。是否能分片、怎样服用或改用混悬液，必须由准确现行标签和药师结合处方确认。", "en": "The score on the 875 mg tablet is an appearance feature of that labelled product, not permission to halve, reduce or substitute another strength. Splitting, administration or changing to suspension requires the exact current label and pharmacist review against the prescription." }, { "zh": "200 mg 与 400 mg 咀嚼片含阿斯巴甜，FDA 标签列出苯丙氨酸信息；这不是对所有人都不适用的结论，但苯丙酮尿症等情况应带准确产品向专业人员核对。", "en": "The 200 mg and 400 mg chewables contain aspartame, and the FDA label lists phenylalanine information. This does not mean they are unsuitable for everyone, but phenylketonuria and related concerns require review of the exact product with a professional." }, { "zh": "有青霉素或头孢类严重过敏史、用药后呼吸困难或广泛皮疹、严重或持续腹泻，或同时使用抗凝药、别嘌醇等药物时，应及时联系当地医生或药师；严重呼吸困难、面唇舌肿胀或晕厥应使用紧急医疗渠道。", "en": "With a serious penicillin or cephalosporin allergy history, breathing trouble or widespread rash after use, severe or persistent diarrhoea, or co-use of anticoagulants, allopurinol or other medicines, contact a local clinician or pharmacist promptly. Severe breathing difficulty, face/lip/tongue swelling or fainting requires emergency care." }, { "zh": "老年人并非按年龄自动改量；FDA 标签提示阿莫西林主要经肾脏排泄，肾功能下降时不良反应风险可能增加。请让开方团队结合肾功能和完整药单核对，不要自行减量、隔天吃或换规格。", "en": "Older age does not automatically determine an amount. The FDA label notes that amoxicillin is substantially excreted by the kidney and risk may be greater with impaired renal function. Ask the prescribing team to review kidney function and the complete medicine list; do not self-reduce, alternate days or change strength." } ], "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "label_literacy_only_no_individual_dosing_or_substitution" }, "mechanismReading": { "title": { "zh": "阿莫西林怎样起作用：它影响细菌在生长时构建细胞壁的过程", "en": "How amoxicillin works: it affects bacterial cell-wall building during growth" }, "summary": { "zh": "FDA 的 AMOXIL 品牌标签描述：阿莫西林通过抑制细菌细胞壁生物合成发挥杀菌作用。它解释的是对敏感细菌的作用路径；不说明个人症状一定由细菌引起，也不决定是否使用、选哪种产品、吃几片或用几毫升。", "en": "The FDA AMOXIL brand label describes amoxicillin as bactericidal through inhibition of bacterial cell-wall biosynthesis. This explains a pathway against susceptible bacteria; it does not establish that an individual's symptoms are bacterial or decide whether to use it, which product to select, how many tablets or how many millilitres." }, "checks": [ { "zh": "可把“细胞壁”理解为细菌维持结构所需的一层构件。阿莫西林的这一路径针对的是细菌；它不能被用来判断感冒、咽痛、咳嗽或其他症状是否需要抗菌药。是否需要治疗仍取决于诊断、检查和目标市场现行标签。", "en": "A “cell wall” can be read as part of the structure a bacterium needs to maintain itself. This pathway concerns bacteria; it cannot decide whether a cold, sore throat, cough or another symptom needs an antibacterial medicine. The need for treatment still depends on diagnosis, testing and the current target-market label." }, { "zh": "“对敏感微生物”是标签中的关键限定：药物机制不是对所有病原体、所有感染部位或所有人的治疗承诺。不要因为过去同类症状曾使用过阿莫西林，就保留、借用、加量、缩短或延长疗程。", "en": "“Susceptible organisms” is a key label limitation: a mechanism is not a treatment promise for every pathogen, infection site or person. Do not retain, borrow, increase, shorten or extend amoxicillin because a similar symptom was treated with it in the past." }, { "zh": "共同机制不会把 AMOXIL NDA 片剂、混悬液、咀嚼片与另一份 ANDA 胶囊标签变成同一产品，更不会形成片数、粒数或毫升数的自行换算公式。", "en": "A shared mechanism does not turn AMOXIL NDA tablets, suspension and chewables and a separate ANDA capsule label into the same product, nor does it create a self-conversion formula for tablets, capsules or millilitres." } ], "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（Microbiology；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "scope": "mechanism_literacy_only_no_individual_dosing_or_substitution" }, "pharmacovigilance": { "status": "official_routes_only_no_live_alert_inference", "reviewedAt": "2026-08-22", "identity": { "brand": "Amoxil", "generic": "阿莫西林", "dosageFormClass": "AMOXIL 片 500/875 mg；复溶后混悬液 200/400 mg 每 5 mL；咀嚼片 125/200/250/400 mg" }, "labelSource": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "productRoutes": [ { "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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_21fe247eb39c0e4a", "label": "FDA：AMOXIL 四个 NDA 补充批准函（2022-06-09）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031%3B%20050754Orig1s021%3B%20050760Orig1s021%3B%20050761Orig1s018ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, "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": "2026-08-30", "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_10e511bf83430e3b", "label": "FDA Orange Book 数据入口（AMOXIL NDA 产品状态复核）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "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." } }, { "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：另一个 AMOXICILLIN 胶囊/混悬液 ANDA 标签（不得合并为 AMOXIL NDA 产品）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" }, "status": "product_level_public_record_verified", "authority": { "zh": "美国国家医学图书馆 DailyMed", "en": "U.S. National Library of Medicine DailyMed" }, "market": { "zh": "美国", "en": "United States" }, "recordType": { "zh": "公开药品标签", "en": "Public medicine label" }, "reviewedAt": "2026-09-02", "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": "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": "2026-08-30", "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-faers-amoxicillin-2023-dies-label-update", "issuedAt": "2023-09-30", "status": "fda_potential_signal_label_update_listing", "title": { "zh": "FDA FAERS 记录：阿莫西林相关产品的说明书更新线索", "en": "FDA FAERS record: labelling-update information for amoxicillin-related products" }, "summary": { "zh": "FDA 的 2023 年 7–9 月潜在严重风险/新安全信息表（页面更新至 2026-03-13）列出 Amoxil 及若干含阿莫西林产品，并说明其“警告和注意事项”及“不良反应”部分已于 2024 年 5 月补入药物诱导性小肠结肠炎综合征（DIES）信息。该表是 FDA 的安全信号与标签更新记录，不用于诊断症状，也不替代手中产品、目标市场现行说明书或专业人员判断。", "en": "FDA’s July–September 2023 potential-signal/new-safety-information table, updated on 2026-03-13, lists Amoxil and several amoxicillin-containing products and states that Warnings and Precautions and Adverse Reactions were updated in May 2024 with drug-induced enterocolitis syndrome (DIES) information. This is an FDA safety-signal and labelling-update record; it does not diagnose symptoms or replace the exact product’s current target-market label and professional review." }, "source": { "id": "src_8c74002392ff8c7f", "label": "FDA：FAERS 2023 年 7–9 月潜在严重风险/新安全信息表（阿莫西林产品标签更新）", "url": "https://www.fda.gov/drugs/fda-adverse-event-monitoring-system-aems/july-september-2023-potential-signals-serious-risksnew-safety-information-identified-fda-adverse", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "dated_public_record", "documentKind": "regulatory_safety_communication", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-22", "reviewedAt": "2026-08-22" } } ], "boundary": { "zh": "本卡将逐药产品级来源与 15 个市场级官方警戒入口放在同一处核验；它不表示已完成该药在所有国家或地区的实时警示检索，也不表示该药存在新的安全警示、召回或风险结论。请先以品牌名、通用名、剂型、规格、所在市场和公告日期逐项匹配；不要仅因看到标题自行停药、换药、加量或减量。", "en": "This card brings together the medicine-specific product route and 15 market-level official vigilance gateways. It does not mean real-time alerts for this medicine have been searched in every country or region, or that the medicine has a new alert, recall or risk conclusion. Match brand, generic name, dosage form, strength, market and notice date item by item; do not self-stop, switch, increase or reduce use from a headline." }, "scope": "official_routes_only_no_live_alert_inference" }, "archive": { "summary": "本页以 FDA 2024 AMOXIL 品牌标签建立四个 NDA 的片剂、复溶后口服混悬液和咀嚼片身份；并明确把当前 DailyMed 的 AMOXICILLIN 胶囊/混悬液 ANDA 标签留在另一条证据链。共享阿莫西林成分、AMOXIL 字样或厂家，不表示产品、剂型、包装和监管路径相同，也不能据包装强度推算个人该吃几片、几粒或几毫升。", "history": "AMOXIL 的美国品牌档案涉及 NDA 050542、050754、050760 和 050761。FDA 2024 标签列出片剂、混悬液和咀嚼片；当前 DailyMed set ID 110ba6b1… 标题为 AMOXICILLIN capsule、营销类别为 ANDA，是不同的阿莫西林产品记录，不再作为 AMOXIL NDA 的包装图片或剂型证明。中国大陆检索线索“阿莫仙”仍需以当前 NMPA 批准文件独立核验。", "sourceDocuments": [ { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 阿莫西林品牌处方信息（四个 NDA；2024-05 修订）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_21fe247eb39c0e4a", "label": "FDA：AMOXIL 四个 NDA 补充批准函（2022-06-09）", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031%3B%20050754Orig1s021%3B%20050760Orig1s021%3B%20050761Orig1s018ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" }, { "id": "src_10e511bf83430e3b", "label": "FDA Orange Book 数据入口（AMOXIL NDA 产品状态复核）", "url": "https://www.fda.gov/drugs/drug-approvals-and-databases/orange-book-data-files", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_dataset", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-08-29", "reviewedAt": "2026-08-29" }, { "id": "src_24ffced7f14f3b2b", "label": "DailyMed（NLM）：另一个 AMOXICILLIN 胶囊/混悬液 ANDA 标签（不得合并为 AMOXIL NDA 产品）", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } ], "applicationNumber": "NDA 050542 / 050754 / 050760 / 050761", "approvalTimeline": [ { "date": "1974", "title": { "zh": "美国初始批准年份", "en": "Initial U.S. approval year" }, "detail": { "zh": "FDA AMOXIL 品牌标签列示 Initial U.S. Approval: 1974；不代表其他市场或当前供应。", "en": "The FDA AMOXIL brand label lists Initial U.S. Approval: 1974; this does not establish another market or current supply." }, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 品牌处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2022-06-09", "title": { "zh": "四个 NDA 的补充批准函", "en": "Supplement approval letter for four NDAs" }, "detail": { "zh": "FDA 批准函把 NDA 050542、050754、050760、050761 与对应 AMOXIL 产品放在同一品牌监管档案中。", "en": "The FDA letter identifies NDA 050542, 050754, 050760 and 050761 with their corresponding AMOXIL products in the brand regulatory record." }, "source": { "id": "src_21fe247eb39c0e4a", "label": "FDA：AMOXIL 四个 NDA 补充批准函", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2022/050542Orig1s031%3B%20050754Orig1s021%3B%20050760Orig1s021%3B%20050761Orig1s018ltr.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "regulatory_product_record", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2024-05", "title": { "zh": "AMOXIL 品牌标签修订", "en": "AMOXIL brand label revised" }, "detail": { "zh": "FDA 品牌标签列出片剂 500/875 mg、混悬液 200/400 mg 每 5 mL、咀嚼片 125/200/250/400 mg。", "en": "The FDA brand label lists 500/875 mg tablets, 200/400 mg per 5 mL suspension, and 125/200/250/400 mg chewables." }, "source": { "id": "src_681f4705630060f9", "label": "FDA：AMOXIL 品牌处方信息", "url": "https://www.accessdata.fda.gov/drugsatfda_docs/label/2024/050542s032lbl.pdf", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "historical_public_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "direct_document", "accessVerifiedAt": "2026-08-30", "reviewedAt": "2026-08-30" } }, { "date": "2026-09-02", "title": { "zh": "完成 NDA/ANDA 身份拆分与包装对照复核", "en": "NDA/ANDA separation and package comparison reviewed" }, "detail": { "zh": "现行 DailyMed AMOXICILLIN 胶囊/混悬液记录被确认是独立 ANDA 标签；8 个准确瓶装面板仅在独立对照区展示，不作为 AMOXIL NDA 的包装图片、剂型或强度证明。", "en": "The current DailyMed AMOXICILLIN capsule/suspension record was confirmed as a separate ANDA label. Eight exact bottle panels are displayed only in a separate comparison section and are not used as AMOXIL NDA package, form or strength evidence." }, "source": { "id": "src_24ffced7f14f3b2b", "label": "DailyMed：独立 AMOXICILLIN ANDA 标签", "url": "https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=110ba6b1-f175-48a1-8e30-616c02212538", "audience": "public", "reviewStatus": "approved", "publish": true, "documentStatus": "current_regulatory_record", "documentKind": "product_label", "market": "US", "accessStatus": "public_access_confirmed", "accessMode": "public_web_page", "accessVerifiedAt": "2026-09-02", "reviewedAt": "2026-09-02" } } ], "marketStatus": [ { "market": { "zh": "美国 AMOXIL NDA", "en": "U.S. AMOXIL NDA" }, "status": { "zh": "品牌标签与 Orange Book 状态已核验", "en": "Brand label and Orange Book status reviewed" }, "detail": { "zh": "当前导入的 Orange Book 快照中，多数 AMOXIL NDA 产品为 DISCN；400 mg/5 mL 混悬液列为 RX、RLD、AB。状态不等于库存或个人可获得性。", "en": "In the imported Orange Book snapshot, most AMOXIL NDA products are DISCN; the 400 mg/5 mL suspension is listed RX, RLD and AB. Status does not establish stock or individual availability." } }, { "market": { "zh": "美国独立 ANDA", "en": "Separate U.S. ANDA" }, "status": { "zh": "作为不同产品对照保留", "en": "Retained as a different-product comparator" }, "detail": { "zh": "DailyMed 当前 250/500 mg 胶囊和 125/250 mg 每 5 mL 混悬液标签不合并进 AMOXIL NDA 产品卡。", "en": "The current DailyMed 250/500 mg capsules and 125/250 mg per 5 mL suspension label is not merged into the AMOXIL NDA cards." } }, { "market": { "zh": "中国大陆", "en": "Mainland China" }, "status": { "zh": "“阿莫仙”仅为检索线索", "en": "‘阿莫仙’ is a search cue only" }, "detail": { "zh": "尚未建立可核验的当前 NMPA 品牌说明书与批准关系，不作等同、现售或原研结论。", "en": "No verified current NMPA brand label and approval relationship has been established; no equivalence, availability or originator conclusion is made." } }, { "market": { "zh": "欧盟、日本及其他市场", "en": "EU, Japan and other markets" }, "status": { "zh": "待逐项建立市场记录", "en": "Market record not established" }, "detail": { "zh": "品牌、剂型、包装和现行状态均须独立核验。", "en": "Brand, dosage form, pack and current status each require independent verification." } } ], "frequentlyAskedQuestions": [ { "question": { "zh": "“阿莫西林”或“500 mg”能唯一定位一个产品、一次用量或一天总量吗？", "en": "Does “amoxicillin” or “500 mg” uniquely identify a product, one dose or a daily total?" }, "answer": { "zh": "不能。500 mg 可能是某一片或某一粒的标签标示量，不会单独说明个人一次吃几片、一天几次或疗程多长。还要同时核对品牌、剂型、规格或浓度、给药途径、市场、标签版本和处方；同一通用名或一个毫克数字不能取代完整产品身份和专业用药安排。", "en": "No. The 500 mg figure may be the labelled amount in one tablet or capsule; by itself it does not state how many units an individual takes at one time, how often or for how long. Brand, dosage form, strength or concentration, route, market, label version and prescription must be checked together. A generic name or one milligram figure does not replace complete product identity and professional instructions." } }, { "question": { "zh": "两粒 250 mg 能直接代替一粒 500 mg，或用 500 mg 片代替 500 mg 胶囊吗？", "en": "Can two 250 mg units directly replace one 500 mg unit, or can a 500 mg tablet replace a 500 mg capsule?" }, "answer": { "zh": "不能只做算术。相同总毫克数不证明产品、剂型、辅料、服用方法、包装、监管路径和处方意图相同。本页的 AMOXIL 品牌片剂、混悬液和咀嚼片，与另一份 AMOXICILLIN ANDA 胶囊／混悬液是不同产品记录；不要自行拼粒数、换剂型或换厂家，请把实际药盒和处方交给药师或开方团队核对。", "en": "Not from arithmetic alone. An equal milligram total does not establish the same product, dosage form, excipients, administration, packaging, regulatory pathway or prescribing intent. The AMOXIL brand tablets, suspension and chewables on this page and the separate AMOXICILLIN ANDA capsule/suspension label are different product records. Do not self-combine unit counts or change form or manufacturer; take the actual pack and prescription to a pharmacist or prescriber." } }, { "question": { "zh": "阿莫西林胶囊可以打开、片剂可以掰开，或混进食物里服用吗？", "en": "Can an amoxicillin capsule be opened, a tablet split, or the medicine mixed with food?" }, "answer": { "zh": "不要从“胶囊”“片剂”或刻痕三个线索自行决定。能否打开、掰开、咀嚼、混合或改用液体，取决于准确产品和现行说明书；AMOXIL 875 mg 片的刻痕只是该产品的外观身份，不是通用的掰片许可。请让药师核对实际药盒、剂型、标签和处方目的，尤其是儿童、吞咽困难者和需要精确量取液体的人。", "en": "Do not decide from the words “capsule” or “tablet” or from a score mark. Opening, splitting, chewing, mixing or changing to a liquid depends on the exact product and current label. The score on an AMOXIL 875 mg tablet is an identity feature of that product, not universal permission to split it. Ask a pharmacist to review the actual pack, dosage form, label and prescribing purpose, especially for children, people with swallowing difficulty or anyone who needs a precisely measured liquid." } }, { "question": { "zh": "AMOXIL、AUGMENTIN、头孢类或其他抗菌药能轮换、一起吃或用剩药补上吗？", "en": "Can AMOXIL, AUGMENTIN, a cephalosporin or another antibacterial be alternated, combined or supplemented with leftovers?" }, "answer": { "zh": "不能根据名称相近、都用于感染或过去经验自行安排。AUGMENTIN 还含克拉维酸，是另一种产品；头孢类和其他抗菌药也有各自的成分、过敏、相互作用和适用边界。不要借药、合并、轮换、补服或自行延长疗程；应由医生结合诊断、必要检查、过敏史、肾功能和完整药单决定，并按当地规则处理剩余抗菌药。", "en": "Not from similar names, a shared infection context or past experience. AUGMENTIN also contains clavulanate and is a different product; cephalosporins and other antibacterials have their own ingredients, allergy, interaction and use boundaries. Do not borrow, combine, alternate, make up doses or self-extend a course. A clinician should use the diagnosis, any necessary tests, allergy history, kidney function and complete medicine list, and leftover antibacterials should be handled under local guidance." } }, { "question": { "zh": "老人、肾功能下降或同时吃很多药时，能自己减量、隔天吃或换成低规格吗？", "en": "Can an older adult, a person with reduced kidney function or someone taking many medicines self-reduce, use alternate days or change to a lower strength?" }, "answer": { "zh": "不能。年龄本身不自动给出剂量，FDA 标签同时提示阿莫西林主要经肾脏排泄，肾功能下降时不良反应风险可能增加。请携带全部药盒、处方、过敏史、近期肾功能资料和完整药单联系开方团队或药师；不要自行减量、隔天吃、换规格或突然停用。若出现呼吸困难、面唇舌肿胀、晕厥或严重意识变化，应立即使用当地急救渠道。", "en": "No. Age alone does not determine an amount, and the FDA label also notes that amoxicillin is substantially excreted by the kidney and adverse-reaction risk may be greater with impaired renal function. Take every pack, the prescription, allergy history, recent kidney-function information and the complete medicine list to the prescriber or pharmacist. Do not self-reduce, use alternate days, change strength or abruptly stop. Breathing difficulty, swelling of the face, lips or tongue, fainting or severe altered awareness requires immediate local emergency care." } } ], "relatedMedicineChecks": [], "relatedArticleSlugs": [ "dosage-forms-are-part-of-medicine-identity", "how-to-read-a-drug-label", "medicine-label-for-everyday-questions", "family-medicine-list-for-pharmacist" ] }, "canonicalUrls": { "zh": "https://origindrug.com/drugs/amoxicillin-amoxil/", "en": "https://origindrug.com/en/drugs/amoxicillin-amoxil/" }, "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." ] }