Docusate Sodium 100 Mg

Docusate Sodium 100 Mg
SPL v1
SPL
SPL Set ID 808abf28-a936-4d62-bb94-9fbe51c571c4
Route
ORAL
Published
Effective Date 2010-07-30
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)

Identifiers & Packaging

Pill Appearance
Imprint: P51 Shape: capsule Color: red Size: 10 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-07-30
Description

Docusate sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)

    generally produces a bowel movement in 12 to 72 hours

Directions
  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
  • adults and children

    12 years and over     		take 1-3

    capsules daily
    children 2 to under

    12 years of age     		take 1

    capsules daily
    children under 2 years ask a doctor
Do Not Use
  • if you are presently taking mineral oil, unless told to do so by a doctor
Package Label
Blister of 60 Capsules
Other Information
  • each capsule contains: sodium 6 mg
  • store at 25°C (77°F)); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients

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

Questions Or Comments?

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--07/2010--NJW

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 stool softener laxative for more than 1 week
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 Capsule)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Structured Label Content

Uses (USES)
  • relieves occasional constipation (irregularity)

    generally produces a bowel movement in 12 to 72 hours

Purpose (PURPOSE)

Stool softener

Directions (DIRECTIONS)
  • Take only by mouth. Doses may be taken as a single daily dose or in divided doses.
  • adults and children

    12 years and over     		take 1-3

    capsules daily
    children 2 to under

    12 years of age     		take 1

    capsules daily
    children under 2 years ask a doctor
Do Not Use (Do not use)
  • if you are presently taking mineral oil, unless told to do so by a doctor
Package Label
Blister of 60 Capsules
Other Information (OTHER INFORMATION)
  • each capsule contains: sodium 6 mg
  • store at 25°C (77°F)); excursions permitted between 15°-30°C (59°-86°F)
Inactive Ingredients (INACTIVE INGREDIENTS)

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

Questions Or Comments? (QUESTIONS OR COMMENTS?)

Distributed by: Major Pharmaceuticals, 31778 Enterprise Drive, Livonia, MI 48150, U.S.A.

call toll free 734-743-6000

Repackaged by:



Contract Pharmacy Services-PA

125 Titus Ave Suite 200

Warrington, PA 18976 USA

Original--07/2010--NJW

Stop Use and Ask A Doctor If (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 stool softener laxative for more than 1 week
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 Capsule) (ACTIVE INGREDIENT (IN EACH CAPSULE))

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

Back to search View SPL set listing Open on DailyMed ↗

Source: dailymed · Ingested: 2026-02-15T11:55:06.457461 · Updated: 2026-03-14T22:52:26.166879