FDA.reportPublic FDA data

DOCUSATE SODIUM 50 MG & SENNOSIDES 8.6 MG CAPSULES (ORANGE)

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2024-05-15
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 21:02:37

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

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 or older 2 softgels once a day 4 softgels twice a day children 6 to 12 years of age 1 softgel once a day 2 softgels twice a day children under 6 years of age ask a doctor ask a doctor

Storage and handling

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

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

Warning Do not use

WARNINGS 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

WARNINGS SECTION

  • stomach pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel movements that continues over a period of 2 weeks

Stop use and ask a doctor if you have

OTC - STOP USE SECTION

  • rectal bleeding or fail to have a bowel movement after use of a laxative. These may 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 accidental overdose, seek professional assistance 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 or older2 softgels once a day4 softgels twice a day
children 6 to 12 years of age1 softgel once a day

2 softgels twice a day

children under 6 years of ageask a doctorask a doctor

Other Information

STORAGE AND HANDLING SECTION

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

Inactive Ingredient

INACTIVE INGREDIENT SECTION

Propylene glycol, Povidone, Colloidal Silicon Dioxide, Yellow wax, Polyethylene glycol 400, Gelatin, Glycerin, Sorbitol Sorbitan Solution, FD&C Yellow No.6, Titanium dioxide and Purified water.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bottle LabelBottle Label

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130335916044825GTIN-13: 0335916044825
EAN-13: 0335916044825
GTIN-12: 335916044825
UPC-A: 335916044825
GTIN storage (14 digits): 00335916044825		Docusate Sodium 50 mg and Sennosides 8.6 mg (Orange) Label.jpg

Products#

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

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
35916-044835916-0448-2

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
1,4-SORBITANAV0YTZ4E6JIACT
GLYCERINPDC6A3C0OXIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
SORBITOL506T60A25RIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
WATER059QF0KO0RIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
YELLOW WAX2ZA36H0S2VIACT
POVIDONE K30U725QWY32XIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
GELATIN, UNSPECIFIED2G86QN327LIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SENNOSIDES3FYP5M0IJXACTIB

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
165cf0fd-b7ba-2bae-e063-6294a90a99a915671380-5fd8-b2ab-e063-6294a90a90312024-05-15WarningsExact identifier
spl id: 165cf0fd-b7ba-2bae-e063-6294a90a99a9
spl set id: 15671380-5fd8-b2ab-e063-6294a90a9031

Reported adverse events (FAERS/openFDA)#

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