说明与适用边界
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spl product data elements
Docusate Sodium Docusate Sodium 100mg Docusate Sodium Docusate D&C RED NO. 33 FD&C Red No. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED WATER SORBITOL TITANIUM DIOXIDE SCU2 Two-toned- white and clear red
spl unclassified section
Drug Facts
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 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 lasts over 2 weeks Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more 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. (1-800-222-1222)
咨询医生 / Ask a doctor
Ask a doctor before use if you have stomach pain nausea vomiting noticed a sudden change in bowel habits that lasts over 2 weeks
停用事项 / Stop use
Stop use and ask a doctor if you have rectal bleeding or fail to have bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a stool softener laxative for more than 1 week
孕哺期 / Pregnancy or breastfeeding
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 right away. (1-800-222-1222)
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 1-3 softgels daily children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor
dosage and administration table
<table ID="i555fcda1-1eb0-42a1-89f2-824cb47412be" width="418" border="1"><tbody><tr><td>adults and children 12 years and over </td><td>take 1-3 softgels daily</td></tr><tr><td>children 2 to under 12 years of age</td><td>take 1 softgel daily</td></tr><tr><td>children under 2 years</td><td>ask a doctor</td></tr></tbody></table>
储存 / Storage and handling
Other information each softgel contains: sodium 6 mg VERY LOW SODIUM store at 25 o C (77 o F); excursions permitted between 15 o -30 o C (59 o -86 o F). keep tightly closed.
辅料 / Inactive ingredients
Inactive ingredients D&C Red #33, edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, purified water, sorbitol special, titanium dioxide
questions
Questions or comments? (866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)
package label principal display panel
PHARBEST NDC 16103-0399-11 *Compare to the active ingredient of Colace ® Docusate Sodium Stool Softener 1000 SOFTGELS 100 mg each THIS PACKAGE FOR HOUSEHOLD WITHOUT YOUNG CHILDREN TAMPER EVIDENT: DO NOT USE IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING Docusate Sodium 100 mg Softgels Package Label
来源、版本与许可
- 资料类型
- 美国药品标签原文
- 版本
- 3 / 20260305
- 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.

