Docusate Sodium, Usp

Docusate Sodium, Usp
SPL v6
SPL
SPL Set ID 6a7e4193-22d2-491e-9842-5c43f571fc65
Route
ORAL
Published
Effective Date 2020-04-10
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, Unspecified Glycerin Polyethylene Glycol 1000 Propylene Glycol Water Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: NV12 Shape: oval Color: red Size: 20 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2000-05-01 Until 2027-10-31
Description

Docusate Sodium 250 mg

Purpose

Stool Softener

Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 250 mg

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.
Questions

Call 1 (800) 682-9862

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.
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.
Inactive Ingredients

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

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 (800) 222-1222.

Active Ingredient (in Each Softgel)

Docusate Sodium 250 mg

Package/label Principal Display Panel

Docusate Sodium, USP

Stool Softener

250 mg Each

Structured Label Content

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.
Purpose

Stool Softener

Questions

Call 1 (800) 682-9862

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.
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.
Inactive Ingredients

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

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 longer than one week unless directed by a doctor.
Ask A Doctor Before Use (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 (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, (If pregnant or breast-feeding,)

ask a healthcare 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 (800) 222-1222.

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

Docusate Sodium 250 mg

Package/label Principal Display Panel (Package/Label Principal Display Panel)

Docusate Sodium, USP

Stool Softener

250 mg Each

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:05:29.449436 · Updated: 2026-03-14T23:07:24.321893