Stool Softener

Manufacturer
Safeway, Inc.
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:12:37

Label at a glance#

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

Indications and uses

for overnight relief from occasional constipation (irregularity) generally produces bowel movement in 6 to 12 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 older 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

  • for overnight relief from occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 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 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 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 may indicate 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 oldertake 2-4 tablets daily 
children 6 to under 12 years of agetake 1-2 tablets daily 
children 2 to under 6 years of agetake up to 1 tablet daily 
children under 2ask 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 lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid, titanium dioxide

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 Colace® 2-IN-1 active ingredients*

Stool Softener

Plus Stimulant Laxative

DOCUSATE SODIUM 50 mg

SENNOSIDES 8.6 mg

For overnight relief of occasional constipation

  • Gentle
  • Dependable

Relief in 6-12 hours

TABLETS

*This product is not manufactured or distributed by Avrio Health L.P., distributor of Colace® 2-IN-1.

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

DISTRIBUTED BY

BETTER LIVING BRANDS LLC

P.O. BOX 99 PLEASANTON, CA 94566-0009

www.betterlivingbrandsLLC.com

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

SIGNATURE CARE Stool Softener
SIGNATURE CARE Stool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
21130-878-20Stool SoftenerPlus Stimulant Laxative200 in 1 BOTTLE, PLASTICTABLET2004

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
21130-878STOOL SOFTENER PLUS STIMULANT LAXATIVE (DOCUSATE SODIUM AND SENNOSIDES) TABLET [SAFEWAY, INC.]4Current NDC, Legacy NDC, 1 package rows20240517_6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d.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
21130-87821130-878-20

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 Stimulant LaxativeDOCUSATE SODIUM AND SENNOSIDESSafeway, Inc.6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d2024-05-15WarningsExact identifier
ndc (package): 21130-878-20
ndc (product): 21130-878
ndc11 (package): 21130087820
spl id: 047a9d14-a528-4ac5-8a25-ed236e4a3baa
spl set id: 6bc9ea37-31b8-4a6d-9b2d-2c80bad4f30d

Reported adverse events (FAERS/openFDA)#

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