说明与适用边界
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spl product data elements
Stool Softener Docusate Sodium FD&C RED NO. 40 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED SORBITOL WATER FD&C YELLOW NO. 6 PROPYLENE GLYCOL DOCUSATE SODIUM DOCUSATE ANHYDROUS CITRIC ACID SORBITAN OVAL PC1
活性成分 / Active ingredient
Active ingredient (in each softgel) Docusate Sodium 100 mg
用途 / Purpose
Purpose Stool Softener
适应证 / Indications and usage
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
警告 / Warnings
Warnings Ask a doctor before use if you • have stomach pain, nausea or vomiting • noticed a sudden change in bowel habits that lasts for over a period of 2 weeks • are presently taking mineral oil Stop use and ask a doctor if • you have rectal bleeding or fail to have a bowel movement. These could be signs of a serious condition. • you need to use a laxative for longer than 1 week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
儿童安全 / Keep out of reach of children
Keep out of reach of children. 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 do not exceed recommended dose adults and children 12 years and older: take 1-3 softgels daily, usually 1 softgel daily after the first bowel movement, or as directed by a doctor. children under 12: ask a doctor
储存 / Storage and handling
Other information • each softgel contains: sodium 5 mg. Very low sodium • store at 59°-77°F (15°-25°C) • keep tightly closed • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
辅料 / Inactive ingredients
Inactive ingredients citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, PEG, propylene glycol, purified water, sorbitol sorbitan solution, white edible ink.
questions
Questions or comments? 1-800-540-3765
package label principal display panel
Package Label 1
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20251204
- 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.