FDA.reportPublic FDA data

Docusate Sodium 50mg and Sennosides 8.6mg

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-04-27
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:55:05

Label at a glance#

ProductDocusate Sodium and Sennosides
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure12 sections

Indications and uses

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

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

OTC - ASK DOCTOR SECTION

Ask a doctor if you have

  • 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.

DOSAGE & ADMINISTRATION SECTION

Directions

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 SAFETY INFORMATION

Other 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

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
1791612sennosides 8.6 MG / docusate sodium 50 MG Oral CapsulePSN2
1791612docusate sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSCD2
1791612DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral CapsuleSY2

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0477-1Docusate Sodium and Sennosides2 in 1 BOXCAPSULE, LIQUID FILLED22
35916-0477-1Docusate Sodium and Sennosides1500 in 1 BAGCAPSULE, LIQUID FILLED15002

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
35916-047735916-0477-1

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

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12026-01-16monthly-update2026-06-03 17:53:04

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 LIMITED4842a767-bb12-9d85-e063-6294a90a19b52026-04-27WarningsExact identifier
ndc (package): 35916-0477-1
ndc (product): 35916-0477
ndc11 (package): 35916047701
spl id: 50038665-465f-1bc7-e063-6394a90abd16
spl set id: 4842a767-bb12-9d85-e063-6294a90a19b5

Reported adverse events (FAERS/openFDA)#

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