FDA.reportPublic FDA data

DOCUSATE SODIUM - SENNOSIDES

Manufacturer
CARDINAL HEALTH | TIME CAP LABORATORIES, INC
Effective date
2019-12-03
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-01 23:56:14

Label at a glance#

ProductDOCUSATE SODIUM - SENNOSIDES
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

ACTIVE iNGREDIENTS (IN EACH TABLET)

Docusate sodium 50 mg

Sennosides 8.6 mg

INACTIVE INGREDIENT SECTION

Inactive ingredients: carnauba wax, colloidal silicon dioxide, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue#2 aluminum lake, FD&C red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

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 (1-800 222-1222) right away.

OTC - PURPOSE SECTION

Purpose:

Stool softener

Stimulant laxative

INDICATIONS & USAGE SECTION

Uses:

Relieves occasional constipation (irregularity)

Generally produces bowel movement in 6 to 12 hours

WARNINGS SECTION

Warnings:

Do not use:

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

If you are presently taking mineral oil, unless directed by a doctor

DOSAGE & ADMINISTRATION SECTION

Directions:

Take only my mouth, Doses may be taken as a single daily dose, prefeably in the evening, or in divided doses.

Adults and children 12 years of age and older: take 2-4 tablets daily

Childreen 6 to under 12 years: take 1-2 tablets daily

Children 2 to under 6 years: take up to 1 talet daily

Children under 2 years: ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

Products#

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

DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-022970000-0229-1

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
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 2L06K8R7DQKIACT
FD&C RED NO. 40WZB9127XOAIACT
HYPROMELLOSES3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
SODIUM BENZOATEOJ245FE5EUIACT
STEARIC ACID4ELV7Z65APIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
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
98cf8599-b67f-fc6f-e053-2a95a90ac7eefa0f005b-bc52-4788-ae4c-2a05ab0023ab2019-12-03WarningsExact identifier
spl id: 98cf8599-b67f-fc6f-e053-2a95a90ac7ee
spl set id: fa0f005b-bc52-4788-ae4c-2a05ab0023ab

Reported adverse events (FAERS/openFDA)#

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