FDA.reportPublic FDA data

Senna S

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2024-08-09
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:17:02

Label at a glance#

ProductSenna S
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor   age starting dosage  maximum dosage  adults and children 12 years of age and over 2 tablets once a day 4 tablets twice a day  children 6 to under 12 years 1 tablet once a day 2 tablets twice a day  children 2 to under 6 years 1/2 tablet once a day  1 tablet twice a day  children under 2 years ask a doctor  ask a doctor 

Storage and handling

each tablet contains : calcium 30 mg each tablet contains : sodium 6 mg LOW SODIUM store at 25ºC (77ºF); excursions permitted between 15-30ºC (59-86ºF)

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

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • if you are now taking mineral oil, unless directed by a doctor
  • laxative products for longer than 1 week 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 continues 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 preferably at bedtime or as directed by a doctor
 agestarting dosage maximum dosage 
adults and children 12 years of age and over2 tablets once a day4 tablets twice a day 
children 6 to under 12 years1 tablet once a day2 tablets twice a day 
children 2 to under 6 years1/2 tablet once a day 1 tablet twice a day 
children under 2 yearsask a doctor ask a doctor 

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 30 mg
  • each tablet contains: sodium 6 mg 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 yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, talc,  titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-888-423-0139

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

COMPARE TO SENOKOT-S® ACTIVE INGREDIENTS†

Vegetable Laxative

+ Stool Softener

DOCUSATE SODIUM 50 mg • STOOL SOFTENER

SENNOSIDES 8.6 MG • LAXATIVE

TABLETS

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

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

†This product is not manufactured or distributed by Avrio Health L.P., distributor of Senokot-S®.

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL 60007

topcare@topco.com

www.topcarebrand.com

Product Labeling

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

TOPCARE HEALTH Stool Softener
TOPCARE HEALTH Stool Softener

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-783-12Senna S120 in 1 BOTTLE, PLASTICTABLET1205
36800-783-12Senna S1 in 1 BOXTABLET15
36800-783-60Senna S1 in 1 BOXTABLET15
36800-783-60Senna S60 in 1 BOTTLE, PLASTICTABLET605

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-783SENNA S (DOCUSATE SODIUM, SENNOSIDES) TABLET [TOP CARE (TOPCO ASSOCIATES LLC)]5Current NDC, Legacy NDC, 4 package rows20240810_3984f4aa-2794-410c-ae9e-ee5bc31c0470.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
36800-78336800-783-60, 36800-783-12

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 YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
ALUMINUM OXIDELMI26O6933IACT

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
Senna SDOCUSATE SODIUM, SENNOSIDESTOP CARE (Topco Associates LLC)3984f4aa-2794-410c-ae9e-ee5bc31c04702024-08-09WarningsExact identifier
ndc (package): 36800-783-60
ndc (package): 36800-783-12
ndc (product): 36800-783
ndc11 (package): 36800078360
ndc11 (package): 36800078312
spl id: e053e3ff-8a66-468f-9065-3e8b05041b52
spl set id: 3984f4aa-2794-410c-ae9e-ee5bc31c0470

Reported adverse events (FAERS/openFDA)#

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