FDA.reportPublic FDA data

Senna-S

Manufacturer
Granulation Technology, Inc.
Effective date
2025-07-30
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 01:08:57

Label at a glance#

ProductSenna-S
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure12 sections

Indications and uses

Relieves occasional constipation (irregularity) Generally produces a 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

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

OTC - WHEN USING SECTION

  • Relieves occasional constipation (irregularity)
  • Generally produces a bowel movement in 6-12 hours

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 one 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 two weeks

Stop using 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 (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take preferably at bedtime or as directed by a doctor
agestarting dosagemaximum dosage
adults and children
12 years of age and over 		2 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 day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

HOW SUPPLIED SECTION

  • Each tablet contains: Calcium 30 mg, Sodium 6 mg LOW SODIUM
  • Store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dibasic calcium phosphate dihydrate, microcrystalline cellulose, pregelatinized starch, colloidal silicon dioxide, magnesium stearate, polyvinyl alcohol, titanium dioxide, polyethylene glycol (PEG) 3350, talc, FD&C red 40 lake, FD&C yellow 5 lake

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 63561-0187-01

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

100 Film-Coated Tablets

btl-label-sennaS-100sbtl-label-sennaS-100s

btl-label-sennaS-100s-peelbtl-label-sennaS-100s-peel

NDC 63561-0187-02

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

220 Film-Coated Tablets

btl-label-sennaS-220sbtl-label-sennaS-220s

btl-label-sennaS-220s-peelbtl-label-sennaS-220s-peel

NDC 63561-0187-03

Senna-S

DOCUSATE SODIUM 50 mg / STOOL SOFTENER

SENNOSIDES 8.6 mg / LAXATIVE

Compare to Senokot-S ®Dual Action Active Ingredients

1000 Film-Coated Tablets

btl-label-sennaS-1000sbtl-label-sennaS-1000s

btl-label-sennaS-1000s-peelbtl-label-sennaS-1000s-peel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN4
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD4
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY4

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
362d7abb-94e6-4c60-9a58-266894157713Product name120231023
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316
d723478e-ad4a-ec23-6bd7-cfe33e1e3840Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63561-0187-1Senna-S100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1004
63561-0187-2Senna-S220 in 1 BOTTLE, PLASTICTABLET, FILM COATED2204
63561-0187-3Senna-S1000 in 1 BOTTLE, PLASTICTABLET, FILM COATED10004

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63561-018763561-0187-2, 63561-0187-1, 63561-0187-3

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
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
MICROCRYSTALLINE CELLULOSE 2005XDI2TS1EZIACT
STARCH, CORNO8232NY3SJIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
MAGNESIUM STEARATE70097M6I30IACT
POLYVINYL ALCOHOL532B59J990IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
POLYETHYLENE GLYCOL 3350G2M7P15E5PIACT
TALC7SEV7J4R1UIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
FD&C YELLOW NO. 5 ALUMINUM LAKEJQ6BLH9FR7IACT
SENNOSIDES3FYP5M0IJXACTIB
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
Senna-SDOCUSATE SODIUM, SENNOSIDESGranulation Technology, Inc.f36c509e-b93b-4d7f-a18a-41e585369a152025-07-30WarningsExact identifier
ndc (package): 63561-0187-2
ndc (package): 63561-0187-1
ndc (package): 63561-0187-3
ndc (product): 63561-0187
ndc11 (package): 63561018703
ndc11 (package): 63561018702
ndc11 (package): 63561018701
spl id: 3b28e1ec-d284-2f66-e063-6294a90aa7f1
spl set id: f36c509e-b93b-4d7f-a18a-41e585369a15

Reported adverse events (FAERS/openFDA)#

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