FDA.reportPublic FDA data

Senna S

Manufacturer
TOP CARE (Topco Associates LLC)
Effective date
2022-04-11
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 22:03:51

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 20 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 20 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

carnauba wax, croscarmellose sodium, D&C yellow #10 aluminum lake, dibasic calcium phosphate dihydrate,FD&C yellow #6 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, silicon dioxide, sodium benzoate, stearic acid,  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

TOP CARE HEALTH Stool Softener Vegetable Laxative
TOP CARE HEALTH Stool Softener Vegetable Laxative

Products#

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

DailyMed product names page 1 of 1 · 19 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
36800-77636800-776-60, 36800-776-12

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 16 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
CARNAUBA WAXR12CBM0EIZIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
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
1efd3ba1-dfe1-4db2-9eda-52512cd5d3ebe16b5a0c-cd4a-403a-80ea-018fb59193172022-04-11WarningsExact identifier
spl id: 1efd3ba1-dfe1-4db2-9eda-52512cd5d3eb
spl set id: e16b5a0c-cd4a-403a-80ea-018fb5919317

Reported adverse events (FAERS/openFDA)#

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