FDA.reportPublic FDA data

STOOL SOFTENER-STIMULANT LAXATIVE

Manufacturer
Kroger Company | TIME CAP LABORATORIES, INC.
Effective date
2025-02-13
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:55:15

Label at a glance#

ProductSTOOL SOFTENER-STIMULANT LAXATIVE
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docusate sodium 50 mg

Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purpose

Stool softener

Stimulant laxative

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation (irregularity)
  • generally produces bowel movement in 6 to 12 hours

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that lasts over 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

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).

DOSAGE & ADMINISTRATION SECTION

Directions

  • 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

OTHER SAFETY INFORMATION

Other information

  • each tablet contains: calcium 20 mg, sodium 6 mg (VERY LOW SODIUM)
  • store at 25°C (77°F) excursions permitted between 15-30°C (59-86°F)

INACTIVE INGREDIENT SECTION

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

OTC - QUESTIONS SECTION

Questions or comments? Call 1-877-290-4008

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

209R-Peytons-60ct IFC209R-Peytons-60ct IFC

209R-Peytons-60ct label209R-Peytons-60ct label

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
41226-209-062025-02-13C16284748780-12cef2736-b27d-d83d-e063-dadaa90ab31f209R Kroger Company Stool Softener / Stimulant Laxative
41226-209-062025-01-30C16284748780-12cef2736-b27d-d83d-e063-dadaa90ab31f209R Kroger Company Stool Softener / Stimulant Laxative

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
41226-209-06STOOL SOFTENER-STIMULANT LAXATIVE60 in 1 BOTTLETABLET, COATED603

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
41226-209STOOL SOFTENER-STIMULANT LAXATIVE TABLET, COATED [KROGER COMPANY]3Current NDC, Legacy NDC, 1 package rows20250215_a22c9f95-e3a9-bfd3-e053-2995a90a3c66.zip

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
41226-20941226-209-06

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
SENNOSIDES3FYP5M0IJXACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB

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-STIMULANT LAXATIVESTOOL SOFTENER-STIMULANT LAXATIVEKroger Companya22c9f95-e3a9-bfd3-e053-2995a90a3c662025-02-13WarningsExact identifier
ndc (package): 41226-209-06
ndc (product): 41226-209
ndc11 (package): 41226020906
spl id: 2e025dfa-9f3b-13e3-e063-6394a90a7490
spl set id: a22c9f95-e3a9-bfd3-e053-2995a90a3c66

Reported adverse events (FAERS/openFDA)#

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