Drug Facts

Drug Facts
SPL v2
SPL
SPL Set ID eaf13cb4-46e1-4cee-9b0f-90706d74fbd0
Route
ORAL
Published
Effective Date 2012-11-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (250 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycols Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: P20 Shape: capsule Color: orange Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-09
Description

Docusate Sodium 250 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate Sodium 250 mg

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.
Directions
  • take 1 softgel daily or as directed by a doctor adults and children over 12 years of age and over:

  • : take as directed by a doctor children under 12 years of age
Other Information
  • sodium 15 mg each softgel contains:
  • store at controlled room temperature 15 - 30 C (59 - 86 F) o o o o
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

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 more than 1 week, unless directed by a doctor
Questions Or Comments?

Call toll free 1-877-753-3935

Ask A Doctor Before Use If

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you fail to have a bowel movement after use
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.

Active Ingredient (in Each Softgel)

Docusate Sodium 250 mg

Stool Softener Extra Strength (docusate Sodium) Capsule, Liquid Filled

Structured Label Content

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

Directions
  • take 1 softgel daily or as directed by a doctor adults and children over 12 years of age and over:

  • : take as directed by a doctor children under 12 years of age
Other Information (Other information)
  • sodium 15 mg each softgel contains:
  • store at controlled room temperature 15 - 30 C (59 - 86 F) o o o o
  • do not use if imprinted safety seal under cap is broken or missing
Inactive Ingredients

edible white ink, FD&C Red No# 40, FD&C Yellow No# 6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water and sorbitol special.

Warnings Do Not Use (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 more than 1 week, unless directed by a doctor
Questions Or Comments? (Questions or comments?)

Call toll free 1-877-753-3935

Ask A Doctor Before Use If (Ask a doctor before use if)

you notice a sudden change in bowel habits that persists over a period of 2 weeks

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you fail to have a bowel movement after use
If Pregnant Or Breast Feeding, (If pregnant or breast-feeding,)

ask a health professional before use.

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.

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

Docusate Sodium 250 mg

Stool Softener Extra Strength (docusate Sodium) Capsule, Liquid Filled (STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED)

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:48.344029 · Updated: 2026-03-14T22:53:45.950699