FDA.reportPublic FDA data

Senna-S - Senna and Docusate Sodium Tablets, 8.6 mg & 50 mg

Manufacturer
HealthLife of USA LLC | Elysium Pharmaceutical Ltd.
Effective date
2023-10-21
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-05-31 23:57:04

Label at a glance#

ProductSENNA-S
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 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 adults and children 12 years of age or 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 - ...

Storage and handling

each tablet contains: calcium 21 mg each tablet contains: sodium 3 mg VERY LOW SODIUM store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F) read all product information before using TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

OTC - PURPOSE SECTION

Active ingredients Purpose (in each tablet)          Purpose

Docusate sodium 50 mg.......................................Stool softner

Sennosides 8.6 mg................................................Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use

SPL UNCLASSIFIED 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 lasts over 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.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

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.

Directions

DOSAGE & ADMINISTRATION SECTION

take preferably at bedtime or as directed by a doctor

  • adults and children 12 years of age or 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- starting dosage:ask a doctor, maximum dosage:ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 21 mg
  • each tablet contains: sodium 3 mg VERY LOW SODIUM
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • read all product information before using
  • TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, colloidal silicon dioxide, dicalcium phosphate, D&C Yellow # 10, FD&C Yellow # 6, hypromellose, microcrystalline cellulose, magnesium stearate, maltodextrin, polyethylene glycol, stearic acid, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call toll free 1-844-832-1138 Monday through Friday 9AM – 5PM EST or www.healthlifeofusa.com

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to the Active Ingredients inSenokot-S®

*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Senokot-S®.

Senna and Docusate Sodium Tablets, 8.6 mg and 50 mg

Principal Display PanelPrincipal Display Panel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN9
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD9
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY9

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
69517-131-02SENNA-S2 in 1 POUCHTABLET, COATED29
69517-131-05SENNA-S500 in 1 BOTTLETABLET, COATED5009
69517-131-10SENNA-S1000 in 1 BOTTLETABLET, COATED10009
69517-131-24SENNA-S24 in 1 BOTTLETABLET, COATED249
69517-131-24SENNA-S1 in 1 CARTONTABLET, COATED19
69517-131-25SENNA-S25 in 1 BOXTABLET, COATED259
69517-131-25SENNA-S2 in 1 POUCHTABLET, COATED29
69517-131-50SENNA-S2 in 1 POUCHTABLET, COATED29
69517-131-50SENNA-S50 in 1 BOXTABLET, COATED509

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69517-131SENNA-S (SENNA AND DOCUSATE SODIUM TABLETS, 8.6 MG AND 50 MG) TABLET, COATED [HEALTHLIFE OF USA LLC]9Current NDC, Legacy NDC, 9 package rows20231021_02a5299c-4b0d-47ac-9838-afd0b0fdd4a6.zip

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
69517-13169517-131-25, 69517-131-50, 69517-131-02, 69517-131-24, 69517-131-05, 69517-131-10

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
SILICON DIOXIDEETJ7Z6XBU4IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
POLYETHYLENE GLYCOL 1000U076Q6Q621IACT
STEARIC ACID4ELV7Z65APIACT
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-SSENNA AND DOCUSATE SODIUM TABLETS, 8.6 MG AND 50 MGHealthLife of USA LLC02a5299c-4b0d-47ac-9838-afd0b0fdd4a62023-10-21WarningsExact identifier
ndc (package): 69517-131-50
ndc (package): 69517-131-05
ndc (package): 69517-131-10
ndc (package): 69517-131-02
ndc (package): 69517-131-24
ndc (package): 69517-131-25
ndc (product): 69517-131
ndc11 (package): 69517013102
ndc11 (package): 69517013125
ndc11 (package): 69517013150
ndc11 (package): 69517013124
ndc11 (package): 69517013105
ndc11 (package): 69517013110
spl id: 083396b6-6a49-ffc7-e063-6294a90ad8e2
spl set id: 02a5299c-4b0d-47ac-9838-afd0b0fdd4a6

Reported adverse events (FAERS/openFDA)#

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