6589d373-0696-44c2-a9d4-a76e45526c5a

SPL v1
SPL
SPL Set ID 6589d373-0696-44c2-a9d4-a76e45526c5a
Route
oral
Published
Effective Date 2025-04-11
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
docusate (250 mg)
Inactive Ingredients
fd&c yellow no. 6 fd&c red no. 40 glycerin gelatin type b bovine (160 bloom) polyethylene glycol, unspecified water sorbitol solution

Identifiers & Packaging

Pill Appearance
Imprint: SCU1 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
otc monograph drug active Since 2025-03-01
Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Medication Information

Warnings

Do not useif you are presently taking mineral oil, unless directed 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.

Uses
  • for the prevention of dry, hard stools
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • adults and children 12 years of age and over:take 1 softgel daily or as directed by a doctor
  • children under 12 years of age:ask a doctor
Other Information
  • each softgel contains:sodium 7 mg
  • store at 15°- 25°C (59°- 77°F)
Inactive Ingredients

Edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special.

Description

Docusate sodium 100 mg

Questions?

call toll free 1-844-912-4012

Section 42229-5

Distributed by:

BI-MART

Eugene, OR 97402

Section 50565-1

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.

Section 51945-4

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Structured Label Content

Warnings (WARNINGS)

Do not useif you are presently taking mineral oil, unless directed 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.

Uses (USES)
  • for the prevention of dry, hard stools
  • for relief of occasional constipation
  • this product generally produces a bowel movement within 12 to 72 hours
Purpose (PURPOSE)

Stool softener laxative

Directions (DIRECTIONS)
  • adults and children 12 years of age and over:take 1 softgel daily or as directed by a doctor
  • children under 12 years of age:ask a doctor
Other Information (OTHER INFORMATION)
  • each softgel contains:sodium 7 mg
  • store at 15°- 25°C (59°- 77°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

Edible ink, FD&C red #40, FD&C yellow #6, gelatin (bovine), glycerin, polyethylene glycol, purified water, sorbitol special.

Questions? (QUESTIONS?)

call toll free 1-844-912-4012

Section 42229-5 (42229-5)

Distributed by:

BI-MART

Eugene, OR 97402

Section 50565-1 (50565-1)

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.

Section 51945-4 (51945-4)

Active Ingredient (in Each Softgel) (ACTIVE INGREDIENT (IN EACH SOFTGEL))

Docusate sodium 100 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:53.843278 · Updated: 2026-03-14T23:08:19.346855