Stool Softener

SPL v1

SPL

SPL Set ID f8393da2-637f-4fee-8bb7-0a5f3e66d13a

Route

ORAL

Published

Effective Date 2021-05-06

Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients

Docusate (250 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 Sorbitan

Identifiers & Packaging

Marketing Status

OTC MONOGRAPH NOT FINAL Active Since 2021-05-07

Description

Drug Facts

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Drug Facts

Uses

for the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Section 42229-5

Drug Facts

Section 53414-9

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

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Do Not Use

if you are presently taking mineral oil, unless directed by a doctor.

Other Information

each softgel contains: sodium 15 mg
store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients

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

Questions Or Comments?

Call toll free: 1-855-215-8180

Principal Display Panel

STOOL SOFTENER

DOCUSATE SODIUM 250mg 100 SOFTGELS

Compare to the active ingredient in COLACE®

NDC 51013-814-24

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 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 250 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 the prevention of dry, hard stools
for relief of occasional constipation
this product generally produces a bowel movement within 12 to 72 hours

Section 42229-5 (42229-5)

Drug Facts

Section 53414-9 (53414-9)

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

Purpose

Stool softener laxative

Directions

adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor
children under 12 years of age: ask a doctor

Do Not Use (Do not use)

if you are presently taking mineral oil, unless directed by a doctor.

Other Information (Other information)

each softgel contains: sodium 15 mg
store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)

Inactive Ingredients (Inactive ingredients)

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

Questions Or Comments? (Questions or comments?)

Call toll free: 1-855-215-8180

Principal Display Panel

STOOL SOFTENER

DOCUSATE SODIUM 250mg 100 SOFTGELS

Compare to the active ingredient in COLACE®

NDC 51013-814-24

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 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 250 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

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Raw Label Data

All Sections (JSON)

{"Uses": "for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours", "42229-5": "Drug Facts", "53414-9": "If pregnant or breast-feeding, ask a health professional before use.", "Purpose": "Stool softener laxative", "Directions": "adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor", "Do not use": "if you are presently taking mineral oil, unless directed by a doctor.", "Other information": "each softgel contains: sodium 15 mg store at 20º-25ºC (68º-77ºF); excursions permitted between 15º-30ºC (59º-86ºF)", "Inactive ingredients": "anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution, and white edible ink", "Questions or comments?": "Call toll free: 1-855-215-8180", "Principal Display Panel": "STOOL SOFTENER DOCUSATE SODIUM 250mg 100 SOFTGELS Compare to the active ingredient in COLACE® NDC 51013-814-24", "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 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 250 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"}

Additional Information

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Source: dailymed · Ingested: 2026-02-15T11:59:32.940840 · Updated: 2026-03-14T22:59:34.580570