Drug Facts

Drug Facts
SPL v1
SPL
SPL Set ID 785a0b85-c565-4fd9-a20f-6fa24df92d43
Route
ORAL
Published
Effective Date 2013-08-22
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Docusate (100 mg)
Inactive Ingredients
D&c Red No. 33 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycols Propylene Glycol Sorbitol

Identifiers & Packaging

Pill Appearance
Imprint: 51A Shape: oval Color: red Size: 5 mm Score: 1
Marketing Status
OTC MONOGRAPH NOT FINAL Active Since 2010-09-15
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 bowel movement in 12 to 72 hours

Directions
  • doses may be taken as a single daily dose or in divided doses

 adults and children 12 years and over                        

 take 1 to 3 softgels daily

 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 currently taking mineral oil, unless directed by a doctor

Questions?

Adverse drug event call (800) 687-0176

Other Information
  • each capsule contains sodium 6 mg
  • store at room temperature 15o-30oC (59o-86oF)
  • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Principal Display Panel
Stop Use and Ask A Doctor If
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • 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 Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain, nausea or vomiting
  • have noticed a sudden change in bowel habits that lasts over 2 weeks
Inactive Ingredients: D&c Red #33,edible Ink, Fd&c Red #40, Fd&c Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Propylene Glycol, Sorbitol Special


Structured Label Content

Uses
  • relieves occasional constipation (irregularity)

  • generally produces bowel movement in 12 to 72 hours

Purpose

Stool softener

Directions
  • doses may be taken as a single daily dose or in divided doses

 adults and children 12 years and over                        

 take 1 to 3 softgels daily

 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 currently taking mineral oil, unless directed by a doctor

Questions?

Adverse drug event call (800) 687-0176

Other Information (Other information)
  • each capsule contains sodium 6 mg
  • store at room temperature 15o-30oC (59o-86oF)
  • Tamper Evident: Do not use if imprinted safety seal under cap is broken or missing
Principal Display Panel
Stop Use and Ask A Doctor If (Stop use and ask a doctor if)
  • you have rectal bleeding
  • you fail to have a bowel movement after use
  • 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 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
  • have noticed a sudden change in bowel habits that lasts over 2 weeks
Inactive Ingredients: D&c Red #33,edible Ink, Fd&c Red #40, Fd&c Yellow #6, Gelatin, Glycerin, Polyethylene Glycol, Propylene Glycol, Sorbitol Special (Inactive ingredients: D&C red #33,Edible ink, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, sorbitol special)


Advanced Ingredient Data

Raw Label Data

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Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:41.596156 · Updated: 2026-03-14T22:53:35.209708