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西药 · 美国药品标签原文

Stool Softener Laxative

DOCUSATE SODIUM

Stool Softener Laxative · P & L Development, LLC。此记录对应特定产品,标签收录不代表所有用途获批。

说明与适用边界

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spl product data elements

Stool Softener Laxative DOCUSATE SODIUM DOCUSATE SODIUM DOCUSATE D&C RED NO. 33 FD&C BLUE NO. 1 FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN GLYCERIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITAN SORBITOL TITANIUM DIOXIDE HYPROMELLOSE, UNSPECIFIED FERROSOFERRIC OXIDE P10

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 lasts 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 signs of a serious condition. you need to use a 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 (1-800-222-1222) right away.

禁用事项 / Do not use

Do not use if you are presently taking mineral oil, unless told to do so by a doctor.

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 a bowel movement after use of a laxative. These could be signs of a serious condition. you need to use a 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 (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 1-3 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><col/><col/><tbody><tr><td styleCode=" Toprule">adults and children 12 years and over</td><td styleCode=" Toprule Lrule">take 1-3 softgels daily </td></tr><tr><td styleCode=" Toprule">children 2 to under 12 years of age </td><td styleCode=" Toprule Lrule">take 1 softgel daily </td></tr><tr><td styleCode=" Toprule">children under 2 years </td><td styleCode=" Toprule Lrule">ask a doctor </td></tr></tbody></table>

储存 / Storage and handling

Other information each softgel contains :sodium 6 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

辅料 / Inactive ingredients

Inactive ingredients black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

questions

Questions or comments? Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

package label principal display panel

Principal Display Panel †Compare to the active ingredient in Colace® Regular Strength Stool Softener stool softener docusate sodium 100 mg stool softener laxative gentle & effective relieves constipation stimulant-free Softgels †This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace Regular Strength Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. Distributed by: PL Developments 200 Hicks Street, Westbury, NY 11590 Product Label WELLNESS BASICS Stool Softener Laxative Docusate sodium 100 mg

来源、版本与许可

资料类型
美国药品标签原文
版本
5 / 20260805
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.
核对原始来源