FDA.reportPublic FDA data

Stool Softener Laxative

Manufacturer
Walgreens
Effective date
2025-05-23
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:01:29

Label at a glance#

ProductStool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure10 sections

Indications and uses

for relief of occasional constipation and irregularity this product generally produces bowel movement in 12 to 72 hours

Dosage and administration

take with a glass of water adults and children 12 years and over take 1-3 liquid gels daily. This dose may be taken as a single daily dose or in divided doses. children 2 to under 12 years of age  take 1 liquid gel daily  children under 2 years  ask a doctor 

Storage and handling

each softgel contains :sodium 7 mg store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium USP, 100 mg

Purpose

OTC - PURPOSE SECTION

Stool softener laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 12 to 72 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you are presently taking mineral oil, unless told to do so by a doctor.

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

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

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or no 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

  • take with a glass of water
adults and children 12 years and overtake 1-3 liquid gels daily. This dose may be taken as a single daily dose or in divided doses.
children 2 to under 12 years of age take 1 liquid gel daily 
children under 2 years ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains:sodium 7 mg
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

citric acid, FD&C red #40, FD&C yellow #6, gelatin, glycerin, polyethylene glycol, propylene glycol, purified water, sorbitol special, white edible 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

†Compare to the active ingredient of Dulcolax® Stool Softener

Gentle Stool Softener

Docusate sodium 100 mg

Stool softener laxative

  • Gentle & easy relief of occasional constipation
  • Stimulant-free

LIQUID GELS

*This product is not manufactured or distributed by A. Nattermann & CIE. GMBH, owner of the registered trademark Dulcolax®.

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

Distributed by:

WALGREEN CO.

DEERFIELD, IL 60015

100% SATISFACTION GUARANTEED

walgreens.com ©2025 Walgreen Co.

PRODUCT OF CHINA

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Stool Softener Docusate Sodium 100 mg
Stool Softener Docusate Sodium 100 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN4
1115005docusate sodium 100 MG Oral CapsuleSCD4
1115005DOSS Sodium 100 MG Oral CapsuleSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-7111-10Stool Softener Laxative1 in 1 BOXCAPSULE, LIQUID FILLED14
0363-7111-10Stool Softener Laxative25 in 1 BOTTLE, PLASTICCAPSULE, LIQUID FILLED254

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0363-7111STOOL SOFTENER LAXATIVE (DOCUSATE SODIUM) CAPSULE, LIQUID FILLED [WALGREENS]4Current NDC, 2 package rows20250524_816c82f8-0fa5-4b22-a226-e8f22f3eaa1d.zip

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-71110363-7111-10
53345-008

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 11 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITAN6O92ICV9RUIACT
SORBITOL506T60A25RIACT
ANHYDROUS CITRIC ACIDXF417D3PSLIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Stool Softener LaxativeDOCUSATE SODIUMWalgreens816c82f8-0fa5-4b22-a226-e8f22f3eaa1d2025-05-23WarningsExact identifier
ndc (package): 0363-7111-10
ndc (product): 0363-7111
ndc11 (package): 00363711110
spl id: f69ca319-0b34-41f1-82e3-0116da65cf5f
spl set id: 816c82f8-0fa5-4b22-a226-e8f22f3eaa1d
DOCUSATE SODIUMDOCUSATE SODIUMHumanwell PuraCap Pharmaceutical (Wuhan), Ltd.b10fdf50-289e-41f3-9b83-a4e4dd892f882024-11-21WarningsExact identifier
ndc (product): 53345-008

Reported adverse events (FAERS/openFDA)#

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