Docusate Sodium, Usp

Docusate Sodium, Usp
SPL v6
SPL
SPL Set ID 2e92ab21-6e5f-4c85-85f9-931d2d573e05
Route
ORAL
Published
Effective Date 2025-08-22
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 Completed Since 2017-05-17 Until 2026-08-31
Description

Docusate Sodium 250 mg

Purpose

Stool Softener

Medication Information

Purpose

Stool Softener

Description

Docusate Sodium 250 mg

.

Overbagged with 10 softgels per bag, NDC 55154-4341-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L5365630-10724 / L5365630-20724

AV Rev. 05/16 (P)

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 1-855-361-3993

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.
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.
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

Ask A Doctor Before Use

if you notice a sudden change in bowel habits that persists over a period of two weeks.

Principal Display Panel

NDC 55154-4341-0

DOCUSATE SODIUM, USP 250 mg

STOOL SOFTENER

10 SOFTGELS

Stop Use and Ask A Doctor

if you have rectal bleeding or you fail to have a bowel movement after 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

If You Are Pregnant Or Breast Feeding,

ask a healthcare professional before use.

Structured Label Content

.

Overbagged with 10 softgels per bag, NDC 55154-4341-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Manufactured for:

AvKARE, Inc.

Pulaski, TN 38478

USA

Distributed By:

Cardinal Health

Dublin, OH 43017

L5365630-10724 / L5365630-20724

AV Rev. 05/16 (P)

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 1-855-361-3993

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.
Do Not Use: (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.
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 (Inactive ingredients)

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

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.

Principal Display Panel

NDC 55154-4341-0

DOCUSATE SODIUM, USP 250 mg

STOOL SOFTENER

10 SOFTGELS

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.

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

If You Are Pregnant Or Breast Feeding, (If you are pregnant or breast-feeding,)

ask a healthcare professional before use.

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:06:52.417629 · Updated: 2026-03-14T23:09:55.704959