Docusate Sodium Softgel Capsules 100mg

Docusate Sodium Softgel Capsules 100mg
SPL v2
SPL
SPL Set ID d15b10b9-18c8-4b3a-9b3f-9604f6ac5963
Route
ORAL
Published
Effective Date 2014-11-17
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Polyethylene Glycol 400 Propylene Glycol Gelatin Glycerin Sorbitol Fd&c Red No. 40 Titanium Dioxide Water

Identifiers & Packaging

Pill Appearance
Imprint: 125 Shape: oval Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2014-12-01
Description

Drug Facts

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Drug Facts

Uses
  • for prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Section 42229-5

Drug Facts

Section 50565-1

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use
Section 50569-3

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Section 50570-1

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 1 week, unless directed by a doctor
Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions
  • take with a glass of water
adults and children 12 years of age and over take 1 to 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 of age consult a physician
Other Information
  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)

Questions Or Comments?

Call toll free: 1-888-333-9792

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Principal Display Panel 50 Softgel Bottle Carton

VALUMEDS

Compare to the active ingredient in

Dulcolax ® Stool Softener

STOOL SOFTENER

DOCUSATE SODIUM 100 MG

  • GENTLE RELIEF
  • EFFECTIVE
  • STIMULANT FREE

50 SOFTGELS

Structured Label Content

Uses
  • for prevention of dry, hard stools
  • for relief of occasional constipation

This product generally produces a bowel movement within 12 to 72 hours.

Section 42229-5 (42229-5)

Drug Facts

Section 50565-1 (50565-1)

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

Section 50566-9 (50566-9)

Stop use and ask a doctor if

  • you have rectal bleeding
  • you fail to have a bowel movement after use
Section 50569-3 (50569-3)

Ask a doctor before use if you notice a sudden change in bowel habits that persists over a period of 2 weeks.

Section 50570-1 (50570-1)

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 1 week, unless directed by a doctor
Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Stool softener

Directions
  • take with a glass of water
adults and children 12 years of age and over take 1 to 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 of age consult a physician
Other Information (Other information)
  • each softgel contains: sodium 6 mg
  • store at controlled room temperature 15°-30°C (59°-86°F)
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients (Inactive ingredients)

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide (for printing)

Questions Or Comments? (Questions or comments?)

Call toll free: 1-888-333-9792

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

Docusate sodium 100 mg

Principal Display Panel 50 Softgel Bottle Carton (PRINCIPAL DISPLAY PANEL - 50 Softgel Bottle Carton)

VALUMEDS

Compare to the active ingredient in

Dulcolax ® Stool Softener

STOOL SOFTENER

DOCUSATE SODIUM 100 MG

  • GENTLE RELIEF
  • EFFECTIVE
  • STIMULANT FREE

50 SOFTGELS

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:58.869222 · Updated: 2026-03-14T22:55:48.069158