Drug Facts

Drug Facts
SPL v4
SPL
SPL Set ID 098d2377-0019-45fe-b995-700b1b1241c4
Route
ORAL
Published
Effective Date 2025-11-17
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 Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Gelatin Glycerin Polyethylene Glycol, Unspecified Propylene Glycol Water Sorbitan Sorbitol Titanium Dioxide Hypromellose, Unspecified Ferrosoferric Oxide

Identifiers & Packaging

Pill Appearance
Imprint: P10 Shape: oval Color: red Color: white Size: 12 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Completed Since 2020-12-31 Until 2027-02-01
Description

Docusate sodium 100 mg

Purpose

Stool softener laxative

Medication Information

Purpose

Stool softener laxative

Description

Docusate sodium 100 mg

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Directions
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-3 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 presently taking mineral oil, unless told to do so by a doctor.

Product Label
WELLNESS BASICS Stool Softener Laxative
Other Information
  • each softgel contains:sodium 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients

black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments?

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Colace® Regular Strength Stool Softener

stool softener

docusate sodium 100 mg

stool softener laxative

Softgels

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

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
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 (1-800-222-1222) right away.

Active Ingredient (in Each Softgel)

Docusate sodium 100 mg

Ask A Doctor Before Use If You Have
  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Structured Label Content

Uses
  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 12 to 72 hours
Purpose

Stool softener laxative

Directions
  • take only by mouth. Doses may be taken as a single daily dose or in divided doses.
adults and children 12 years and over take 1-3 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 presently taking mineral oil, unless told to do so by a doctor.

Product Label
WELLNESS BASICS Stool Softener Laxative
Other Information (Other information)
  • each softgel contains:sodium 6 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)
Inactive Ingredients (Inactive ingredients)

black iron oxide, D&C red #33, FD&C blue #1, FD&C red #40, FD&C yellow #6, gelatin, glycerin, hypromellose, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, titanium dioxide

Questions Or Comments? (Questions or comments?)

Call 1-877-753-3935 Monday-Friday 9AM-5PM EST

Principal Display Panel

†Compare to the active ingredient in Colace® Regular Strength Stool Softener

stool softener

docusate sodium 100 mg

stool softener laxative

Softgels

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace Regular Strength Stool Softener.

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING.

Distributed by: PL Developments

200 Hicks Street, Westbury, NY 11590

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
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 (1-800-222-1222) 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
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:07:15.302412 · Updated: 2026-03-14T23:10:29.645873