说明与适用边界
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spl product data elements
Docusate sodium Docusate sodium GELATIN GLYCERIN SORBITOL DOCUSATE SODIUM DOCUSATE SORBITAN FD&C YELLOW NO. 6 WATER FD&C RED NO. 40 Oblong AD2
活性成分 / Active ingredient
Active Ingredient (In each softgel) Docusate Sodium.... 100 mg
用途 / Purpose
Purpose Stool softener laxative
适应证 / Indications and usage
Uses relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
警告 / Warnings
Warnings Do not use if you are presently taking mineral oil, unless told to do so by a doctor. Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that last over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be a signs of a serious condition. you need to use a stool softner laxative for more than 1 week If pregnant or breast-feeding, ask a health professional before use.
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 (1-800-222-1222) right away.
用法用量原文 / Dosage and administration
Directions take only by mouth. Doses may be taken as a single daily dose or in divided doses. adults and children 12 years and over : take 1 to 3 softgels daily children 2 to under 12 years of age : take 1 softgel daily children under 2 years : ask a doctor
储存 / Storage and handling
Other Information each softgel contains: sodium 5 mg store between 20ºC - 25ºC (68-77ºF);excursions permitted between 15-30ºC (59-86ºF)
辅料 / Inactive ingredients
Gelatin, Glycerin, Sorbitol Sorbitan solution, Purified water , D&C Red #40, D&C Yellow #6, White Ink
questions
Questions or Comments ? Call 1-855-642-2594
spl unclassified section
Compare to the active ingredient in Colace® Regular Strength Stool Softener† †This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® Regular Strength Stool Softener. Rev.: 03/2023 Manufactured by: Apnar Pharma LLP East Windsor, NJ 08520
package label principal display panel
NDC 24689-130-01 Docusate Sodium 100mg Stool Softener Laxative MADE IN USA 100 Softgels Docusate Sodium Softgel lable-100mg
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 2 / 20250109
- 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.

