FDA.reportPublic FDA data

Sennosides

Manufacturer
SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2026-01-27
Label type
HUMAN OTC DRUG LABEL
Version
7
Source
full-release
Hydrated at
2026-06-01 01:35:03

Label at a glance#

ProductSennosides
Active ingredientSENNOSIDES
Label structure13 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement within 6-12 hours

Dosage and administration

take preferably at bedtime or as directed by a doctor adults and children 12 years and over 1 capsule once a day. Maximum 2 capsules twice a day. children 6 to under 12 years maximum 1 capsule twice a day children under 6 years ask a doctor

Storage and handling

store below 30°C (86°F) and protect from light and moisture

Label contents#

Full prescribing information#

Actice ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each softgel)
Sennosides 17.2 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Do not use

OTC - DO NOT USE SECTION

■ 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 continues over a period of 2 weeks

Stop use and consult 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.

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 adults and children 12 years and over
  • 1 capsule once a day. Maximum 2 capsules twice a day. children 6 to under 12 years
  • maximum 1 capsule twice a day children under 6 years
  • ask a doctor

Other Information

STORAGE AND HANDLING SECTION

store below 30°C (86°F) and protect from light and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

FD&C blue no.1, FD&C blue no.2, FD&C red no. 40, FD&C yellow no.6, fumaric acid, gelatin, glycerol, lecithin, liquid sorbitol, methyl hydroxy benzoate, purified water, refined soya oil, titanium dioxide, yellow bees wax.

Questions or comments?

OTC - QUESTIONS SECTION

call 1-877-770-3183: weekdays 9:00 AM to 4:30 PM EST

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

bulk labelbulk label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
2169295sennosides 17.2 MG Oral CapsulePSN7
2169295sennosides, USP 17.2 MG Oral CapsuleSCD7
2169295sennosides 17.2 MG Oral CapsuleSY7

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
baf7f49c-75b6-496b-a00e-8e766a8e4f03Product name120210127
ebc62596-fc97-4d03-9483-7ba095d25db7Product name120151210
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
35916-0423-1Sennosides1000 in 1 BAGCAPSULE, LIQUID FILLED10007
35916-0423-2Sennosides2000 in 1 BOXCAPSULE, LIQUID FILLED20007

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
35916-042335916-0423-1, 35916-0423-2

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 15 matching rows.

Name, UNII, Kind table
NameUNIIKind
WATER059QF0KO0RIACT
GLYCERINPDC6A3C0OXIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
METHYLPARABENA2I8C7HI9TIACT
FUMARIC ACID88XHZ13131IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
FD&C RED NO. 40WZB9127XOAIACT
SORBITOL506T60A25RIACT
FD&C BLUE NO. 1H3R47K3TBDIACT
GELATIN2G86QN327LIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
FD&C BLUE NO. 2L06K8R7DQKIACT
YELLOW WAX2ZA36H0S2VIACT
SENNOSIDES3FYP5M0IJXACTIB
SOYBEAN OIL241ATL177AIACT

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
SennosidesSENNOSIDESSOFTGEL HEALTHCARE PRIVATE LIMITED94936bd4-8bbf-6211-e053-2995a90a21382026-01-27Exact identifier
ndc (package): 35916-0423-1
ndc (package): 35916-0423-2
ndc (product): 35916-0423
ndc11 (package): 35916042301
ndc11 (package): 35916042302
spl id: 49593180-32d8-788f-e063-6394a90a230f
spl set id: 94936bd4-8bbf-6211-e053-2995a90a2138

Reported adverse events (FAERS/openFDA)#

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