Stool Softener

Manufacturer
Strategic Sourcing Services LLC
Effective date
2024-05-29
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 21:01:53

Label at a glance#

ProductStool Softener Extra Strength
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

relieves occasional constipation  this product generally produces a bowel movement within 12 to 72 hours

Dosage and administration

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

Storage and handling

each softgel contains: sodium 13 mg store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

 Docusate sodium 250 mg

Purpose

OTC - PURPOSE SECTION

 Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation 
  • this product generally produces a bowel movement within 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that last over 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: sodium 13 mg
  • store between 20-25ºC(68-77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

anhydrous citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, isopropyl alcohol, lecithin, mannitol, mineral oil, polyethylene glycol, propylene glycol, purified water, sorbitan, sorbitol, white ink 

Questions or comments?

OTC - QUESTIONS SECTION

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

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EXTRA STRENGTH

Stool Softener

Docusate sodium 250 mg

Stool Softener Laxative

  • Stimulant-free
  • Relief of occasional constipation

SOFTGELS

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

Distributed by McKesson Corp.

6555 State Highway 161 Irving, TX 75039

www.healthmart.com

 

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

HEALTHMART Extra Strength Stool Softener
HEALTHMART Extra Strength Stool Softener

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
62011-0474STOOL SOFTENER EXTRA STRENGTH (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [STRATEGIC SOURCING SERVICES LLC]3Legacy NDC20240531_cb92de8b-1e52-406c-ba38-3de1cd809d0a.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
62011-0474-1EA - Each62011-0474b449543c-2066-4104-90cf-f3de569d9b3512021-11-09

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
62011-047462011-0474-1

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5e7b138b-d80d-4353-a11c-cea8d26ac07ccb92de8b-1e52-406c-ba38-3de1cd809d0a2024-05-29WarningsExact identifier
spl id: 5e7b138b-d80d-4353-a11c-cea8d26ac07c
spl set id: cb92de8b-1e52-406c-ba38-3de1cd809d0a

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.