Stool Softener

Stool Softener
SPL v2
SPL
SPL Set ID 3442ffb7-659c-46a9-8164-ab0d5fb52f14
Route
ORAL
Published
Effective Date 2016-10-02
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
Anhydrous Citric Acid Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitol

Identifiers & Packaging

Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2016-10-02
Description

Drug Facts

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Drug Facts

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Section 42229-5

Drug Facts

Section 50568-5

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9

If pregnant or breast-feeding, ask a health professional before use.

Directions

take with a glass of water

adults and children 12 years and over

     1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

children 2 to under 12 years of age

     1 softgel daily

children under 2 years of age

     ask a doctor

Other Information
  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive humidity
Inactive Ingredients

citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments?

Call toll free: 1-800-833-6278

Principal Display Panel

STOOL SOFTENER 

DOCUSATE SODIUM 100mg  100 SOFTGELS

Compare to the active ingredient in DULCOLAX®

NDC 51013-120-24

Stop Use and Ask A Doctor If
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week
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 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks 

Structured Label Content

Uses
  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours
Section 42229-5 (42229-5)

Drug Facts

Section 50568-5 (50568-5)

Ask a doctor or pharmacist before use if you are presently taking mineral oil

Section 53414-9 (53414-9)

If pregnant or breast-feeding, ask a health professional before use.

Purpose

Stool softener laxative

Directions

take with a glass of water

adults and children 12 years and over

     1 to 3 softgels daily. This dose may be taken as a single daily dose or in divided doses.

children 2 to under 12 years of age

     1 softgel daily

children under 2 years of age

     ask a doctor

Other Information (Other information)
  • each softgel contains: sodium 5 mg
  • store at room temperature 15°-30°C (59°-86°F)
  • protect from excessive humidity
Inactive Ingredients (Inactive ingredients)

citric acid, FD&C red # 40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special and white edible ink

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-833-6278

Principal Display Panel

STOOL SOFTENER 

DOCUSATE SODIUM 100mg  100 SOFTGELS

Compare to the active ingredient in DULCOLAX®

NDC 51013-120-24

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week
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 100 mg

Ask A Doctor Before Use If You Have (Ask a doctor before use if you have)
  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks 

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:56:57.334997 · Updated: 2026-03-14T22:55:46.109144