FDA.reportPublic FDA data

Docusate Sodium 50 mg & Sennosides 8.6 mg Capsules(Orange)

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:35:12

Label at a glance#

ProductDocusate Sodium and Sennosides
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure13 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. Age Starting Dosage Maximum Dosage adults and children 12 years of age and older 2 softgels once a day 4 softgels twice a day children 6 to 12 years 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

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 causes bowel movement in 6-12 hours

Warnings

WARNINGS SECTION

Do not use

  • 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 movements that continues over a period of 2 weeks

OTC - STOP USE SECTION

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These may be signs of a serious condition.

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, 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 DosageMaximum Dosage
    adults and children 12 years of age and older2 softgels once a day4 softgels twice a day
    children 6 to 12 years1 softgel once a day2 softgels twice a day
    children under 6 years of ageask a doctorask a doctor

Other information

OTHER SAFETY INFORMATION

  • each softgel contains: Sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°- 30°C (59°- 86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C yellow no.6, gelatin, glycerin, polyethylene glycol 400, povidone K 30, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow wax

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bulk labelbulk labelBottle LabelBottle Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bulk labelbulk label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1791612sennosides 8.6 MG / docusate sodium 50 MG Oral CapsulePSN3
1791612docusate sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSCD3
1791612DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSY3

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130335916045310GTIN-13: 0335916045310
EAN-13: 0335916045310
GTIN-12: 335916045310
UPC-A: 335916045310
GTIN storage (14 digits): 00335916045310		Docusate Sodium 50 mg and Sennosides 8.6 mg Orange.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0453-1Docusate Sodium and Sennosides500 in 1 BOTTLECAPSULE, GELATIN COATED5003
35916-0453-3Docusate Sodium and Sennosides2 in 1 BOXCAPSULE, GELATIN COATED23
35916-0453-3Docusate Sodium and Sennosides3000 in 1 POUCHCAPSULE, GELATIN COATED30003

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
35916-045335916-0453-1, 35916-0453-3

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
WATER059QF0KO0RIACT
YELLOW WAX2ZA36H0S2VIACT
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
GLYCERINPDC6A3C0OXIACT
POVIDONE K30U725QWY32XIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
GELATIN2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SORBITOL506T60A25RIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
TITANIUM DIOXIDE15FIX9V2JPIACT

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
Docusate Sodium and SennosidesDOCUSATE SODIUM AND SENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED19830f9a-27b1-910d-e063-6294a90adace2026-01-27WarningsExact identifier
ndc (package): 35916-0453-3
ndc (package): 35916-0453-1
ndc (product): 35916-0453
ndc11 (package): 35916045303
ndc11 (package): 35916045301
spl id: 47dbd4d5-5093-0741-e063-6294a90a001a
spl set id: 19830f9a-27b1-910d-e063-6294a90adace

Reported adverse events (FAERS/openFDA)#

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