FDA.reportPublic FDA data

STOOL SOFTENING SENNA LAXATIVE

Manufacturer
TARGET CORPORATION | TIME CAP LABORATORIES, INC. | TIME CAP LABORATORIES, INC
Effective date
2019-02-28
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 22:59:00

Label at a glance#

ProductSTOOL SOFTENING SENNA LAXATIVE
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
Label structure9 sections

Indications and uses

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

Dosage and administration

Directions: Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable. Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day Children 6 to under 12 years: - Starting dosage: 1 tablet on...

Label contents#

Full prescribing information#

ACTIVE INGREDIENTS

OTC - ACTIVE INGREDIENT SECTION

Each Tablet contains:

Docusate sodium 50 mg

Sennosides 8.6 mg

INACTIVE INGREDIENTS

INACTIVE INGREDIENT SECTION

INACTIVE INGREDIENTS: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, d-c yellow#10 aluminum lake, fd&c yellow#6 aluminum lake, Hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

INDICATIONS AND USAGE

INDICATIONS & USAGE SECTION

Relieves occasional constipation (irregularity); generally causes a bowel movement in 6-12 hours

PURPOSE

OTC - PURPOSE SECTION

Stimulant Laxative and Stool Softener

DOSAGE AND ADMINISTRATION

DOSAGE & ADMINISTRATION SECTION

Directions:

Take preferably at bedtime or as directed by a doctor. If you do not have a comfortable bowel movement by the second day, increase dose by one tablet (not to exceed maximum dosage) or decrease dose until you are comfortable.

Adults and children 12 years and older: - Starting dosage: 2 tablets once a day - Maximum dosage: 4 tablets twice a day

Children 6 to under 12 years: - Starting dosage: 1 tablet once a day-Maximum dosage: 2 tablets twice a day

Children 2 to under 6 years - Starting dosage: 1/2 tablet once a day- Maximum dosage: 1 tablet twice a day

Children under 2 years - Ask a doctor

WARNINGS

WARNINGS SECTION

WARNINGS:

Do not use this product

If you are presently taking mineral oil unless directed by a doctor

Laxative products for longer than 1 week unless directed by a doctor

PREGNANT OR BREAST FEEDING

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breastfeeding, ask a health professional before use.

KEEP OUT OF REACH OF CHILDREN

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.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

192R 30CT BOX192R 30CT BOX

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
11673-192-03STOOL SOFTENING SENNA LAXATIVE30 in 1 BOTTLETABLET302

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
11673-192STOOL SOFTENING SENNA LAXATIVE (SENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MG) TABLET [TARGET CORPORATION]2Current NDC, Legacy NDC, 1 package rows20190329_7c74bd91-6687-2b89-e053-2a91aa0ad6b8.zip

Products#

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

DailyMed product names page 1 of 1 · 20 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
11673-19211673-192-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES A AND B1B5FPI42ENACTIB
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
STEARIC ACID4ELV7Z65APIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT

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 SOFTENING SENNA LAXATIVESENNOSIDES 8.6 MG - DOCUSATE SODIUM 50 MGTARGET CORPORATION7c74bd91-6687-2b89-e053-2a91aa0ad6b82019-02-28WarningsExact identifier
ndc (package): 11673-192-03
ndc (product): 11673-192
ndc11 (package): 11673019203
spl id: 81f51705-1b12-f726-e053-2991aa0a8e02
spl set id: 7c74bd91-6687-2b89-e053-2a91aa0ad6b8

Reported adverse events (FAERS/openFDA)#

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