Docusate Sodium

Docusate Sodium
SPL v1
SPL
SPL Set ID e87768d5-7ffe-44a6-a2d0-44f3c538ed67
Route
ORAL
Published
Effective Date 2018-09-18
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Water Sorbitan Sorbitol Titanium Dioxide

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2018-10-01
Description

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Label

Section 50570-1

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

Directions

take only by mouth. Doses may be taken as a single daily does 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

Other Information
  • each softgel contains: sodium 6 mg
  • store at 25°C (77°F); excursions premitted between 15-30°C (59-86°F)
Inactive Ingredients

D&C red #33, editable ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients.

Questions Or Comments?

Call 1-800-736-3437

Stop Use and Ask A Doctor If
  • you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of serious condition.
  • you need to use a laxative for more than 1 week

Keep Out of Reach of Children

In case of accidental overdose, get medical help or contact a Poison Control Center right away

If Pregnant Or Breast Feeding,

ask a health professional before use.

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomitting
  • notice a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Label

Section 50570-1 (50570-1)

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

Purpose

Stool softener laxative

Directions

take only by mouth. Doses may be taken as a single daily does 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

Other Information
  • each softgel contains: sodium 6 mg
  • store at 25°C (77°F); excursions premitted between 15-30°C (59-86°F)
Inactive Ingredients (Inactive ingredients)

D&C red #33, editable ink, FD&C blue #1*, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol*, purified water, sorbitan, sorbitol, titanium dioxide

*contains one or more of these ingredients.

Questions Or Comments? (Questions or comments?)

Call 1-800-736-3437

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or fail to have bowel movement after use of laxative. These could be signs of serious condition.
  • you need to use a laxative for more than 1 week

Keep Out of Reach of Children (Keep out of reach of children)

In case of accidental overdose, get medical help or contact a Poison Control Center right away

If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

Active Ingredient (in Each Softgel) (Active ingredient (in each softgel))

Docusate Sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomitting
  • notice a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:39.744278 · Updated: 2026-03-14T22:55:16.609561