说明与适用边界
此页按所列地区、版本归档。标签内容可能更新，具体产品请核对原始来源；本站关联表示阅读线索，不表示药品与器械可兼容或可替换。
spl product data elements
Simethicone Simethicone SILICON DIOXIDE FD&C BLUE NO. 1 FD&C RED NO. 40 D&C YELLOW NO. 10 GELATIN GLYCERIN PEPPERMINT OIL TITANIUM DIOXIDE WATER DIMETHICONE DIMETHICONE OVAL PC2
活性成分 / Active ingredient
Active ingredient (in each capsule) Simethicone 125 mg
用途 / Purpose
Purpose Antiflatulent
适应证 / Indications and usage
Uses for relief of: bloating pressure fullness stuffed feeling commonly referred to as gas
警告 / Warnings
Warnings Stop use and ask a doctor if condition persists. If pregnant or breast-feeding, ask a health care professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
停用事项 / Stop use
Stop use and ask a doctor if condition persists.
孕哺期 / Pregnancy or breastfeeding
If pregnant or breast-feeding, ask a health care professional before use.
儿童安全 / Keep out of reach of children
Keep out of reach of children.
过量 / Overdosage
In case of overdose, get medical help or contact a Poison Control Center right away.
用法用量原文 / Dosage and administration
Directions adults: swallow with water 1 or 2 softgels as needed after meals or at bedtime do not exceed 4 softgels per day unless directed by doctor
储存 / Storage and handling
Other information store at controlled room temperature 15°-30°C (59°-86°F) protect from heat and moisture do not use if imprinted safety seal under cap is broken or missing
辅料 / Inactive ingredients
Inactive ingredients D&C Yellow #10, FD&C Blue #1, FD&C Red #40, gelatin, glycerin, peppermint oil, purified water, titanium dioxide and white edible ink Manufactured by: Humanwell PuraCap Pharmaceutical (Wuhan) Ltd. Wuhan, Hubei 430206, China
package label principal display panel
PRINCIPAL DISPLAY PANEL - Shipping Label SIMETHICONE CAPSULES, 125 mg Quantity : 25000 Capsules NDC. No : 53345-009-01 IMPORTANT: Inspect immediate upon receipt. This is a bulk shipment intended for further processing only. Protect from heat, humidity, and light. Do not refrigerate. CAUTION : "FOR FURTHER MANUFACTURING, PROCESSING OR REPACKING" Shipping Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20241121
- 获取时间
- 2026-10-08
- 许可
- openFDA public data; retain original label attribution. See 查看来源 and dataset source notices. Public access does not imply approval or unrestricted rights to every submitted label.