Drug Facts

Drug Facts
SPL v7
SPL
SPL Set ID 2d657c29-c701-4db0-9c06-f680bd921241
Route
ORAL
Published
Effective Date 2025-08-12
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Sorbitan Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol Glycerin Medium-chain Triglycerides

Identifiers & Packaging

Pill Appearance
Imprint: P51 Shape: oval Color: orange Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2021-05-28 Until 2026-05-28
Description

Docusate Sodium 100 mg

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Docusate Sodium 100 mg

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours
Directions
  • take with a glass of water
adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided dose
children 2 to under 12 years of age take 1 softgel 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.

Product Label
Other Information
  • each softgel contains:sodium 5 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions Or Comments?

 Call 1-877-753-3935Monday-Friday 9AM-5PM EST

Principal Display Panel

Docusate Sodium

Stool Softener Laxative

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

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 a signs of a serious condition.
  • you need to use a 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 (1-800-222-1222)  right away.

Active Ingredient (in Each Softgel)

Docusate Sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Structured Label Content

Uses
  • for relief of occasional constipation (irregularity)
  • this product generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • take with a glass of water
adults and children 12 years and over take 1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided dose
children 2 to under 12 years of age take 1 softgel 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.

Product Label
Other Information (Other information)
  • each softgel contains:sodium 5 mg
  • store at 25ºC (77ºF);excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

edible ink, FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water sorbitan, sorbitol

Questions Or Comments? (Questions or comments?)

 Call 1-877-753-3935Monday-Friday 9AM-5PM EST

Principal Display Panel

Docusate Sodium

Stool Softener Laxative

TAMPER EVIDENT: DO NOT USE IF SEAL IS BROKEN OR MISSING FROM BOTTLE.

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 a signs of a serious condition.
  • you need to use a 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 (1-800-222-1222)  right away.

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

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 habits that last over 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:08.564507 · Updated: 2026-03-14T23:10:21.394156