基础药物信息
产品类型:HUMAN OTC DRUG
商品名:Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
通用名:Aluminum Hydroxide, Magnesium Hydroxide, and Simethicone
剂型:SUSPENSION
市场类别:OTC MONOGRAPH DRUG
包装信息
包装NDC:60687-877-76
包装描述:10 TRAY in 1 CASE (60687-877-76) / 10 CUP, UNIT-DOSE in 1 TRAY (60687-877-51) / 30 mL in 1 CUP, UNIT-DOSE (60687-877-45)
开始上市日期:2025-06-01
结束上市日期:未提供
是否样品包装:否
生产与审批
标签持有者:American Health Packaging
生产商名称:American Health Packaging
OTC专论编号:M001
列表过期日期:2026-12-31
是否为原始包装商:是
给药信息
给药途径:ORAL
是否为成品药:是(FDA不审核未完成的产品,未完成的产品视为未获批)
上市日期:2025-06-01
退市日期:未提供
活性成分
成分 1
名称:ALUMINUM HYDROXIDE
浓度:200 mg/5mL
成分 2
名称:DIMETHICONE, UNSPECIFIED
浓度:20 mg/5mL
成分 3
名称:MAGNESIUM HYDROXIDE
浓度:200 mg/5mL
药品说明书
药品说明书及标签信息:
药理分类:Calculi Dissolution Agent [EPC]、Increased Large Intestinal Motility [PE]、Inhibition Large Intestine Fluid/Electrolyte Absorption [PE]、Inhibition Small Intestine Fluid/Electrolyte Absorption [PE]、Magnesium Ion Exchange Activity [MoA]、Osmotic Activity [MoA]、Osmotic Laxative [EPC]、Skin Barrier Activity [PE]、Stimulation Large Intestine Fluid/Electrolyte Secretion [PE]
DEA管制级别:未管制