Drug Facts

Drug Facts

SPL v1

SPL

SPL Set ID 64a4d802-0c72-46ce-9c1d-d01947523669

Route

ORAL

Published

Effective Date 2007-01-22

Document Type 34390-5 HUMAN OTC DRUG LABEL

Composition & Product

Active Ingredients

Docusate (100 mg)

Inactive Ingredients

D&c Yellow No. 10 Fd&c Red No. 40 Gelatin Glycerin Polyethylene Glycol 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 2007-01-22

Description

Docusate sodium 100 mg

Purpose

Stool softener

Medication Information

Purpose

Stool softener

Description

Docusate sodium 100 mg

Uses

prevents/relieves dry hard stool
results usually occurs 1 to 3 days after the first dose

Warnings

Directions

do not exceed recommended dose

adults and children over 12 years	take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years	take 1 softgel daily
children under 6 years	consult a doctor

Do Not Use

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor

Questions?

Adverse drug event call: (866) 562-2756

Other Information

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature 15^oto 30^oC (59^o to 86^oF)
protect from moisture

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

1000 SOFTGELS

100 mg each

Stop Use and Ask A Doctor If

you have no bowel movement after 3 days
you have rectal bleeding

These could be signs of a serious condition

Ask A Doctor Before Use If You

are taking mineral oil
have noticed a sudden change in bowel habits that last over 2 weeks

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

Inactive Ingredients: D&c Yellow #10, Fd&c Red #40, Gelatin, Glycerin, Ink White, Polyethylene Glycol, Sorbitol, Propylene Glycol.

Structured Label Content

Uses

prevents/relieves dry hard stool
results usually occurs 1 to 3 days after the first dose

Purpose

Stool softener

Warnings

Directions

do not exceed recommended dose

adults and children over 12 years	take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter
children 6 to 12 years	take 1 softgel daily
children under 6 years	consult a doctor

Do Not Use (Do not use)

when abdominal pain, nausea, or vomiting are present
for more than one week unless directed by a doctor

Questions?

Adverse drug event call: (866) 562-2756

Other Information (Other information)

Tamper Evident: Do not use if safety seal under cap is broken or missing
store at room temperature 15^oto 30^oC (59^o to 86^oF)
protect from moisture

Principal Display Panel

*Compare to the active ingredient of Colace®

Docusate Sodium

Stool Softener

1000 SOFTGELS

100 mg each

Stop Use and Ask A Doctor If (Stop use and ask a doctor if)

you have no bowel movement after 3 days
you have rectal bleeding

These could be signs of a serious condition

Ask A Doctor Before Use If You (Ask a doctor before use if you)

are taking mineral oil
have noticed a sudden change in bowel habits that last over 2 weeks

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

Inactive Ingredients: D&c Yellow #10, Fd&c Red #40, Gelatin, Glycerin, Ink White, Polyethylene Glycol, Sorbitol, Propylene Glycol. (Inactive ingredients: D&C yellow #10, FD&C red #40, gelatin, glycerin, ink white, polyethylene glycol, sorbitol, propylene glycol.)

Advanced Ingredient Data

[{"name": "Docusate", "unii": "M7P27195AG", "classCode": "ACTIB", "strengthNumerator": "100", "strengthDenominator": "1", "strengthNumeratorUnit": "mg", "strengthDenominatorUnit": "1"}, {"name": "D&C Yellow No. 10", "unii": "35SW5USQ3G", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "FD&C Red No. 40", "unii": "WZB9127XOA", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Gelatin", "unii": "2G86QN327L", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Glycerin", "unii": "PDC6A3C0OX", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Polyethylene Glycol", "unii": "3WJQ0SDW1A", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Propylene Glycol", "unii": "6DC9Q167V3", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}, {"name": "Sorbitol", "unii": "506T60A25R", "classCode": "IACT", "strengthNumerator": "", "strengthDenominator": "", "strengthNumeratorUnit": "", "strengthDenominatorUnit": ""}]

Raw Label Data

All Sections (JSON)

{"Uses": "prevents/relieves dry hard stool results usually occurs 1 to 3 days after the first dose", "Purpose": "Stool softener", "Directions": "do not exceed recommended dose adults and children over 12 years take 1-2 softgels daily until first bowel movement; 1 softgel daily thereafter children 6 to 12 years take 1 softgel daily children under 6 years consult a doctor", "Do not use": "when abdominal pain, nausea, or vomiting are present for more than one week unless directed by a doctor", "Questions?": "Adverse drug event call: (866) 562-2756", "Other information": "Tamper Evident: Do not use if safety seal under cap is broken or missing store at room temperature 15 o to 30 o C (59 o to 86 o F) protect from moisture", "Principal Display Panel": "*Compare to the active ingredient of Colace® Docusate Sodium Stool Softener 1000 SOFTGELS 100 mg each", "Stop use and ask a doctor if": "you have no bowel movement after 3 days you have rectal bleeding These could be signs of a serious condition", "Ask a doctor before use if you": "are taking mineral oil have noticed a sudden change in bowel habits that last over 2 weeks", "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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:55:05.684870 · Updated: 2026-03-14T22:52:25.436081