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西药 · 美国药品标签原文

Docusate Sodium

DOCUSATE SODIUM

Docusate Sodium · National Vitamin Company。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 DOCUSATE SODIUM DOCUSATE FD&C RED NO. 40 FD&C YELLOW NO. 6 GELATIN, UNSPECIFIED GLYCERIN POLYETHYLENE GLYCOL 1000 PROPYLENE GLYCOL WATER SORBITOL NV12

活性成分 / Active ingredient

Active Ingredient (in each softgel) Docusate Sodium 250 mg

用途 / Purpose

Purpose Stool Softener

适应证 / Indications and usage

Uses • For the relief of occasional constipation. • Helps to prevent dry, hard stools. • This product generally produces a bowel movement within 12 to 72 hours.

警告 / Warnings

WARNINGS Do not use: • If you are currently taking mineral oil, unless directed by a doctor. • When abdominal pain, nausea, or vomiting are present. • For longer than one week unless directed by a doctor. Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks. Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use. If pregnant or breast-feeding, ask a healthcare professional before use. Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

咨询医药人员 / Ask a doctor or pharmacist

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of two weeks.

停用事项 / Stop use

Stop use and ask a doctor if you have rectal bleeding or you fail to have a bowel movement after use.

孕哺期 / Pregnancy or breastfeeding

If pregnant or breast-feeding, ask a healthcare 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.

用法用量原文 / Dosage and administration

Directions Adults and Children over 12 years of age Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.

dosage and administration table

<table width="100%"><col width="37%"/><col width="63%"/><tbody><tr><td styleCode="Rrule Botrule Toprule " valign="top"><paragraph>Adults and Children over 12 years of age</paragraph></td><td styleCode="Botrule Toprule " valign="top"><paragraph>Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor.</paragraph></td></tr><tr><td styleCode="Rrule Botrule " valign="top"><paragraph>Children under 12 years of age</paragraph></td><td styleCode="Botrule " valign="top"><paragraph>Do not use this product for children under 12 years of age, unless directed by a doctor.</paragraph></td></tr></tbody></table>

spl unclassified section

Other Information • Each softgel contains 13 mg of Sodium. • Store at room temperature between 15°C to 30°C (59°F to 86°F). • Do not use if printed seal under cap is broken or missing. • For identification purposes, each softgel will have an imprint that reads NV12.

辅料 / Inactive ingredients

Inactive Ingredients FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.

questions

Questions Call 1 (800) 682-9862

package label principal display panel

Package/Label Principal Display Panel NDC 54629-601-01 Life-Line® Docusate Sodium, USP Stool Softener 250 mg Each 100 Softgels Manufactured and Distributed by National Vitamin Company Casa Grande, AZ 85122 Bottle Label Bottle Label

来源、版本与许可

资料类型
美国药品标签原文
版本
3 / 20241212
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