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
Purpose

Stool softener laxative

Description

Drug Facts

Medication Information

Uses
  • for temporary relief of occasional constipation and 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

     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

Description

Drug Facts

Principal Display Panel

STOOL SOFTENER 

DOCUSATE SODIUM 100mg  100 SOFTGELS

Compare to the active ingredient in DULCOLAX®

NDC 51013-120-24

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.

Questions Or Comments?

Call toll free: 1-800-833-6278

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
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

Principal Display Panel

STOOL SOFTENER 

DOCUSATE SODIUM 100mg  100 SOFTGELS

Compare to the active ingredient in DULCOLAX®

NDC 51013-120-24

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.

Questions Or Comments? (Questions or comments?)

Call toll free: 1-800-833-6278

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