Stool Softener

Manufacturer
United Natural Foods, Inc. dba UNFI
Effective date
2024-06-14
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:13:42

Label at a glance#

ProductStool Softener Plus Stimulant
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 6 to12 hours

Dosage and administration

Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses. adults and children 12 years and over take 2-4 tablets daily  children 6 to under 12 years of age take 1-2 tablets daily  children 2 to under 6 years of age  take up to 1 tablet daily  children under 2  ask a doctor 

Label contents#

Full prescribing information#

Active ingredients (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to12 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • laxative products for longer than 1 week unless told to do so by a doctor
  • 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
  • noticed a sudden change in bowel habits that lasts over a period of 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.

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 right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take only by mouth. Doses may be taken as a single daily dose, preferably in the evening, or in divided doses.
adults and children 12 years and overtake 2-4 tablets daily 
children 6 to under 12 years of agetake 1-2 tablets daily 
children 2 to under 6 years of age take up to 1 tablet daily 
children under 2 ask a doctor 

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 5 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

carnauba wax, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C red #40 aluminum, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silcon dioxide, sodium benzoate, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-855-423-2630

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

compare to Colace® 2-IN-1 active ingredients*

Stool Softener + Stimulant Laxative

docusate sodium 50 mg/

sennosides 8.6 mg

  • gentle, dependable
  • relief in 6-12 hours

tablets

*This product is not manufactured of distributed by AVrio Health L.P., distributor of Colace® 2-IN1

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

DISTRIBUTED BY: UNFI

PROVIDENCE, RI 02908 USA

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

EQUALINE Stool Softener
EQUALINE Stool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN3
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD3
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY3

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41163-778-10Stool SoftenerPlus Stimulant100 in 1 BOTTLE, PLASTICTABLET1003

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41163-778STOOL SOFTENER PLUS STIMULANT (DOCUSATE SODIUM AND SENNOSIDES) TABLET [UNITED NATURAL FOODS, INC. DBA UNFI]3Current NDC, Legacy NDC, 1 package rows20240616_6c8c7c46-3ded-4e89-8e16-30eeb72aa08b.zip

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
41163-77841163-778-10

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
Stool Softener Plus StimulantDOCUSATE SODIUM AND SENNOSIDESUnited Natural Foods, Inc. dba UNFI6c8c7c46-3ded-4e89-8e16-30eeb72aa08b2024-06-14WarningsExact identifier
ndc (package): 41163-778-10
ndc (product): 41163-778
ndc11 (package): 41163077810
spl id: b0672540-0f64-4d5d-ade2-16a05d40ba75
spl set id: 6c8c7c46-3ded-4e89-8e16-30eeb72aa08b

Reported adverse events (FAERS/openFDA)#

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