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西药 · 美国药品标签原文

Docusate Sodium

DOCUSATE SODIUM 100MG

Docusate Sodium · Pharbest Pharmaceuticals, Inc.。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

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.
核对原始来源