FDA.reportPublic FDA data

Senna S

Manufacturer
Marlex Pharmaceuticals Inc
Effective date
2025-11-21
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:17:36

Label at a glance#

ProductSenna S
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

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

Dosage and administration

take preferably at bedtime or as directed by a doctor if you do not have a comfortable bowel movement by the second day, increase does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable age starting dosage maximum dosage adults and children 12 years of age and older 2 tablets once a day 4 tablets twice a day children 6 to 12 years 1 tablet once a day 2 tablets twice a day child...

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

SENNOSIDES AND DOCUSATE SODIUM-sennosides, docusate sodium tabletMarlexPharmaceuticals, Inc.

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

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SennaS

Drug Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50mg Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

  • 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

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • stomach pain
  • Nausea
  • Vomiting
  • a sudden change in bowel movements that persists over 2 weeks

Stop use and ask a doctorif

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use if a laxative. These could be signs of 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
  • if you do not have a comfortable bowel movement by the second day, increase does by one tablet (do not exceed maximum dosage) or decrease does until you are comfortable
agestarting dosagemaximum dosage
adults and children 12 years of age and older2 tablets once a day4 tablets twice a day
children 6 to 12 years1 tablet once a day2 tablets twice a day
children 2 to 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

SAFE HANDLING WARNING SECTION

  • each tablet contains:calcium 4mg, sodium 8mg
  • store at 20°C to 25°C (68°F to 77°F) excursions permitted between 15°30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

Colloidal silicon dioxide, croscarmellose sodium, D&C Yellow #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

*Compare to the active ingredients in SENOKOT-S®

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 10135-0669-01
Senna S
100 TABLET

669-01669-01

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN6
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD6
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY6

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
10135-669-012021-03-15C16284748780-1ba0f9c33-38f4-a910-e053-dadaa90a0b85Senna S
10135-669-012021-01-29C16284748780-1ba0f9c33-38f4-a910-e053-dadaa90a0b85Senna S

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
10135-669-01Senna S100 in 1 BOTTLETABLET1006
10135-669-01Senna S1 in 1 CARTONTABLET16

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
10135-669-01EA - Each10135-66951876ebf-0b3c-4bef-8ac8-0ff470318d8c12019-02-13

Products#

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

DailyMed product names page 1 of 1 · 15 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
10135-66910135-669-01

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 AND SENNOSIDESMarlex Pharmaceuticals Inc9c87759f-3856-4f30-b5ea-4b37ed90f18c2025-11-21WarningsExact identifier
ndc (package): 10135-669-01
ndc (product): 10135-669
ndc11 (package): 10135066901
spl id: 441ef4c5-4902-159d-e063-6394a90aebd0
spl set id: 9c87759f-3856-4f30-b5ea-4b37ed90f18c

Reported adverse events (FAERS/openFDA)#

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