FDA.reportPublic FDA data

Sennosides and Docusate Sodium

Manufacturer
Asclemed USA, Inc. | ASCLEMED USA INC. DBA ENOVACHEM
Effective date
2025-02-08
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:54:47

Label at a glance#

ProductSennosides and Docusate Sodium
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure15 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a bowel movement in 6 to 12 hours

Dosage and administration

take preferably at bedtime or as directed by a doctor do not exceed maximum dosage age starting dosage maximun dosage adults and children 12 years of age or older 2 tablets once a day 4 tablets twice a day children 6 to under 12 years 1 tablet once a day 2 tablets twice a day children 2 to under 6 years 1/2 tablet once a day 1 tablet twice a day children under 2 years ask a doctor ask a doctor

Storage and handling

each tablet contains: calcium 4 mg, sodium 8 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drugs Facts

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Docusate sodium 50 mg

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)

generally produces a bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

this product if you are presently taking mineral oil, unless directed by a doctor

laxative products for longer than 1 week unless directed by a doctor

Warnings

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

stomach pain

nausea

vomiting

noticed a sudden change in bowel habits that continues over a period of 2 weeks

Warnings

OTC - STOP USE SECTION

Stop use and ask a doctor ifyou have rectal bleeding or fail to have bowel movement after use of a laxative. These may indicate a serious condition.

Warnings

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

Warnings

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

do not exceed maximum dosage

agestarting dosagemaximun dosage
adults and children 12 years of age or older2 tablets once a day4 tablets twice a day
children 6 to under 12 years1 tablet once a day2 tablets twice a day
children 2 to under 6 years1/2 tablet once a day1 tablet twice a day
children under 2 yearsask a doctorask a doctor

Other information

STORAGE AND HANDLING SECTION

each tablet contains: calcium 4 mg, sodium 8 mg

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, croscarmellose sodium, D&C Yello #10 Aluminum Lake, FD&C Yellow #6 Aluminum Lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, titanium dioxide

Questions or comments?

OTC - QUESTIONS SECTION

Call 516-341-0666

8:30am-4:30pm ET, Mon-Fri

SPL UNCLASSIFIED SECTION

Repackaged and Relabeled by:
Enovachem PHARMACEUTICALS
Torrance, CA 90501

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

labellabel

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN1
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD1
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY1

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
76420-918-01Sennosides and Docusate Sodium100 in 1 BOTTLETABLET1001
76420-918-30Sennosides and Docusate Sodium30 in 1 BOTTLETABLET301
76420-918-60Sennosides and Docusate Sodium60 in 1 BOTTLETABLET601
76420-918-90Sennosides and Docusate Sodium90 in 1 BOTTLETABLET901

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
76420-918SENNOSIDES AND DOCUSATE SODIUM (SENNOSIDES, DOCUSATE SODIUM) TABLET [ASCLEMED USA, INC.]1Current NDC, 4 package rows20250212_2db546de-20dc-4697-aff2-12471f073b1d.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
76420-918-01EA - Each76420-9182b1dc849-cd90-429f-bdb0-b2d26b4555fe12025-12-16
76420-918-30EA - Each76420-9189c740598-59ec-4309-96e1-014fc75e81b312025-12-16
76420-918-60EA - Each76420-9184a74e332-f81e-4023-a838-81f0bb1b684a12025-12-16
76420-918-90EA - Each76420-918c69acccf-1598-4347-a911-b35b781f125612025-12-16
69618-065-01EA - Each69618-06535e11638-08d0-404a-80a4-fbbd3dd082f212021-03-02

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
76420-91876420-918-30, 76420-918-60, 76420-918-90, 76420-918-01
69618-065

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
TITANIUM DIOXIDE15FIX9V2JPIACT
SODIUM BENZOATEOJ245FE5EUIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMAsclemed USA, Inc.2db546de-20dc-4697-aff2-12471f073b1d2025-02-08WarningsExact identifier
ndc (package): 76420-918-60
ndc (package): 76420-918-30
ndc (package): 76420-918-90
ndc (package): 76420-918-01
ndc (product): 76420-918
ndc11 (package): 76420091890
ndc11 (package): 76420091801
ndc11 (package): 76420091830
ndc11 (package): 76420091860
spl id: 2d9d8f71-cc36-459a-e063-6394a90acf8e
spl set id: 2db546de-20dc-4697-aff2-12471f073b1d
Sennosides and Docusate SodiumSENNOSIDES, DOCUSATE SODIUMReliable-1 Laboratories LLCa97a1829-f62f-2014-e053-2a95a90a8cc52025-01-15WarningsExact identifier
ndc (product): 69618-065

Reported adverse events (FAERS/openFDA)#

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