FDA.reportPublic FDA data

Stool Softener

Manufacturer
CVS Pharmacy
Effective date
2025-11-06
Label type
HUMAN OTC DRUG LABEL
Version
10
Source
full-release
Hydrated at
2026-06-01 01:42:19

Label at a glance#

ProductStool Softener Plus Stimulant Laxative
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 directed 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 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 over take 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 30 mg
  • each tablet contains: sodium 6 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #2 aluminum lake, FD&C red #40 aluminum lake,  hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silcon dioxide, talc, 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*

2-IN-1

STOOL SOFTENER LAXATIVE

Docusate Sodium, 50 mg 

Sennosides, 8.6 mg 

Plus Stimulant Laxative

Overnight Relief for Occasional Constipation

TABLETS

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., distributor of Colace® 2- IN-1.

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

Distributed by: CVS Pharmacy, Inc.

One CVS Drive, Woonsocket, RI 02895

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CVS Stool Softener Laxative TCB
CVS Stool Softener Laxative TCB

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN10
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD10
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY10

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130050428140505GTIN-13: 0050428140505
EAN-13: 0050428140505
GTIN-12: 050428140505
UPC-A: 050428140505
GTIN storage (14 digits): 00050428140505		stool-with-laxative-tcb-1.jpg

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69842-887-10Stool SoftenerPlus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET10010
69842-887-10Stool SoftenerPlus Stimulant Laxative1 in 1 BOXTABLET110
69842-887-25Stool SoftenerPlus Stimulant Laxative250 in 1 BOTTLE, PLASTICTABLET25010
69842-887-40Stool SoftenerPlus Stimulant Laxative400 in 1 BOTTLE, PLASTICTABLET40010

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
69842-887-10EA - Each69842-88751722957-df50-48b9-b417-be7d1b33b44c12024-08-12

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69842-88769842-887-10, 69842-887-40, 69842-887-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C BLUE NO. 2 ALUMINUM LAKE4AQJ3LG584IACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
82024-09-04full-release2026-06-01 00:18:47

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 SENNOSIDESCVS Pharmacy1ed3a4d3-629c-4d70-ac03-d0db9f77a9c82025-11-06WarningsExact identifier
ndc (package): 69842-887-40
ndc (package): 69842-887-10
ndc (package): 69842-887-25
ndc (product): 69842-887
ndc11 (package): 69842088740
ndc11 (package): 69842088725
ndc11 (package): 69842088710
spl id: 02721327-2031-433b-8a5e-5c5b526b577d
spl set id: 1ed3a4d3-629c-4d70-ac03-d0db9f77a9c8

Reported adverse events (FAERS/openFDA)#

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