FDA.reportPublic FDA data

Gentle Stool Softener

Manufacturer
WALGREEN COMPANY
Effective date
2025-10-31
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:41:40

Label at a glance#

ProductGentle Stool Softener
Active ingredientDOCUSATE SODIUM
Label structure15 sections

Indications and uses

relieves of occasional constipation (irregularity) generally produces a bowel movement within 12 to 72 hours

Dosage and administration

take with a glass of water Adults and children 12 years of age and over take 1 to 3 capsules daily. This dose may be taken as asingle daily dose or ib divided doses. Children 2 to under 12 years of age 1 capsule daily. Children under 2 years of age Ask a doctor

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

Active ingredient (in each liquid-filled capsule)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 100 mg 

Purpose

OTC - PURPOSE SECTION

Stool Softner laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves of occasional constipation (irregularity)
  • generally produces a bowel movement within 12 to 72 hours

WARNINGS SECTION

Warnings

Do not use if you are presently taking mineral o il

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomittiong
  • noticed a sudden change in bowel habits that lasts more than 2 weeks

Stop use and ask a doctor if you

OTC - STOP USE SECTION

  • you have rectal bleeding ot no bowel movement after using this product. These could be signs of a serious condition.
  • yo need to use laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water

Adults and children 12 years of age and over

take 1 to 3 capsules daily. This dose may be taken as asingle daily dose or ib divided doses.

Children 2 to under 12 years of age

1 capsule daily.

Children under 2 years of age

Ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each capsule contains: sodium 5 mg Very Low Sodium
  • Store at room temperature 20-25°C (68-77°F)
  • protect from excessive humidity

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, polyethylene glycol, povidone, propylene
glycol, purified water, sorbitol solution.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-373-6981

SPL UNCLASSIFIED SECTION

Distributed by: Walgreen co.
200 Wilmot rd., Deerfield, IL 60015

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Dulcolax ® Stool Softener active ingredient *

GENTLE STOOL SOFTENER

DOCUSATE SODIUM 100 mg / STOOL SOFTENER LAXATIVE

25 LIQUID GELS

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1115005docusate sodium 100 MG Oral CapsulePSN5
1115005docusate sodium 100 MG Oral CapsuleSCD5
1115005DOSS Sodium 100 MG Oral CapsuleSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0363-1172-25Gentle Stool Softener25 in 1 BOTTLECAPSULE, LIQUID FILLED255
0363-1172-25Gentle Stool Softener1 in 1 PACKAGECAPSULE, LIQUID FILLED15

Products#

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

DailyMed product names page 1 of 1 · 12 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0363-11720363-1172-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 10 matching rows.

Name, UNII, Kind table
NameUNIIKind
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL SOLUTION8KW3E207O2IACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42024-12-26full-release2026-06-01 00:48:57

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
Gentle Stool SoftenerDOCUSATE SODIUMWALGREEN COMPANY169b33f9-e559-47bf-bbba-c7eda4762c7f2025-10-31WarningsExact identifier
ndc (package): 0363-1172-25
ndc (product): 0363-1172
ndc11 (package): 00363117225
spl id: 4279ecaf-40a2-e171-e063-6294a90a20f0
spl set id: 169b33f9-e559-47bf-bbba-c7eda4762c7f

Reported adverse events (FAERS/openFDA)#

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