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西药 · 美国药品标签原文

Stool Softener

DOCUSATE SODIUM

Stool Softener · TOP CARE (Topco Associates 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 Docusate Sodium DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN POLYETHYLENE GLYCOL, UNSPECIFIED PROPYLENE GLYCOL WATER SORBITOL GLYCERIN CITRIC ACID MONOHYDRATE SORBITAN PC1

活性成分 / Active ingredient

Active ingredient (in each softgel) Docusate Sodium USP, 100 mg

用途 / Purpose

Purpose Stool softener laxative

适应证 / Indications and usage

Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours

警告 / Warnings

Warnings Do not use if you are presently taking mineral oil, unless directed a doctor. Ask a doctor before use if 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 no bowel movement after using a laxative. These could be a sign 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 (1-800-2222-1222) right away.

咨询医生 / Ask a doctor

Ask a doctor before use if 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 no bowel movement after using a laxative. These could be a sign 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 (1-800-2222-1222) right away.

用法用量原文 / Dosage and administration

Directions take with a glass of water adults and children 12 years and over take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses children 2 to under 12 years of age take 1 softgel daily children under 2 years ask a doctor

dosage and administration table

<table width="508px"><col width="1px"/><col width="1px"/><tbody><tr><td styleCode=" Botrule Toprule Rrule">adults and children 12 years and over</td><td styleCode=" Botrule Toprule">take 1-3 softgels daily. This dose may be taken as a single daily dose or in divided doses </td></tr><tr><td styleCode=" Botrule Rrule">children 2 to under 12 years of age</td><td styleCode=" Botrule">take 1 softgel daily</td></tr><tr><td styleCode=" Botrule Rrule">children under 2 years </td><td styleCode=" Botrule">ask a doctor</td></tr></tbody></table>

储存 / Storage and handling

Other information each softgel contains: sodium 7 mg store at 25ºC (77ºF); excursion permitted between 15-30ºC (59-86ºF)

辅料 / Inactive ingredients

Inactive ingredients citric acid, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible ink

questions

Questions or comments? Call toll free 1-888-423-0139

package label principal display panel

Principal display panel COMPARE TO THE ACTIVE INGREDIENT IN DULCOLAX® STOOL SOFTENER† Stool Softener DOCUSATE SODIUM 100 mg STOOL SOFTENER LAXATIVE Comfortable relief of painful, hard, dry stools Stimulant-free Relief of occasional constipation SOFTGELS †This product is not manufactured or distributed by Chattem, Inc., distributor of Dulcolax® Stool Softener. TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION. DISTRIBUTED BY: TOPCO ASSICIATES LLC ITASCA, IL 60143 Product Label TOPCARE HEALTH Stool Softener Docusate Sodium USP 100 mg

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20260115
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