FDA.reportPublic FDA data

STOOL SOFTENER

Manufacturer
We Care Distributor Inc. | MEDGEL PVT LTD
Effective date
2016-03-09
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-05-31 22:45:24

Label at a glance#

ProductSTOOL SOFTENER
Active ingredientDOCUSATE SODIUM
Label structure9 sections

Indications and uses

■ for prevention of dry, hard stools ■ for relief of occasional constipation. This product 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 softgels daily. This dose may be taken as single daily dose or in divided doses. ■ children 2 to under 12 years of age: take 1 softgels daily ■ children under 2 years of age: consult a physician.

Storage and handling

■ each softgel contains sodium 6 mg ■ store at controlled room temperature 15°-30°C (59°-86°F) ■ read all product information before using

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredient (in each softgel)                 Purpose

Docusate sodium 100 mg..............................Stool softener

Uses

INDICATIONS & USAGE SECTION

■ for prevention of dry, hard stools

■ for relief of occasional constipation. This product generally produces a bowel movement within 12 to 72 hours.

Warnings

WARNINGS SECTION

Do not use

SPL UNCLASSIFIED SECTION

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

■ when abdominal pain, nausea, or vomiting are present

■ for longer than 1 week, unless directed by a doctor

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

■ you have rectal bleeding

■ you fail to have a bowel movement after use

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.

Directions

DOSAGE & ADMINISTRATION SECTION

■ take with a glass of water

■ adults and children 12 years of age and over: take 1 to 3 softgels daily. This dose may be taken as single daily dose or in divided doses.

■ children 2 to under 12 years of age: take 1 softgels daily

■ children under 2 years of age: consult a physician.

Other information

STORAGE AND HANDLING SECTION

■ each softgel contains sodium 6 mg

■ store at controlled room temperature 15°-30°C (59°-86°F)

■ read all product information before using

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C Red # 40, FD&C Yellow #6, gelatin, glycerine, polyethylene glycol 400, propylene glycol, purified water, sorbitol solution, titanium dioxide

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients in Dulcolax® Stool Softener

STOOL SOFTENER

Docusate Sodium Softgels, 100 mg

TO OPEN
PUSH IN TAB AND PULL OUT

25 Pouches of 2 Softgels Each

Principal Display Panel - 50 Pouch BoxPrincipal Display Panel - 50 Pouch Box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1248224docusate sodium 200 MG Oral CapsulePSN7
1248224docusate sodium 200 MG Oral CapsuleSCD7
1248224DOSS Sodium 200 MG Oral CapsuleSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70005-015-022020-01-31C16284748780-19d75b9d0-a390-f424-e053-dadaa90a57ceSTOOL SOFTENER - Docusate Sodium Softgels, 100 mg
70005-015-252020-01-31C16284748780-19d75b9d0-a390-f424-e053-dadaa90a57ceSTOOL SOFTENER - Docusate Sodium Softgels, 100 mg
70005-015-502020-01-31C16284748780-19d75b9d0-a390-f424-e053-dadaa90a57ceSTOOL SOFTENER - Docusate Sodium Softgels, 100 mg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70005-015-02STOOL SOFTENER2 in 1 POUCHCAPSULE, LIQUID FILLED27
70005-015-25STOOL SOFTENER25 in 1 BOXCAPSULE, LIQUID FILLED257
70005-015-25STOOL SOFTENER2 in 1 POUCHCAPSULE, LIQUID FILLED27
70005-015-50STOOL SOFTENER50 in 1 BOXCAPSULE, LIQUID FILLED507
70005-015-50STOOL SOFTENER2 in 1 POUCHCAPSULE, LIQUID FILLED27

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70005-015STOOL SOFTENER (DOCUSATE SODIUM 100 MG) CAPSULE, LIQUID FILLED [WE CARE DISTRIBUTOR INC.]7Legacy NDC, 5 package rows20160315_299ac7ea-3335-4d9d-893d-1ace0984b03e.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
70005-01570005-015-25, 70005-015-50, 70005-015-02

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
DOCUSATE SODIUMF05Q2T2JA0ACTIB
FD&C RED NO. 40WZB9127XOAIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
SORBITOL506T60A25RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
WATER059QF0KO0RIACT

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
5d23093e-30d7-488d-8df2-0ec78055321b299ac7ea-3335-4d9d-893d-1ace0984b03e2016-03-09WarningsExact identifier
spl id: 5d23093e-30d7-488d-8df2-0ec78055321b
spl set id: 299ac7ea-3335-4d9d-893d-1ace0984b03e

Reported adverse events (FAERS/openFDA)#

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