Docusate Sod/Senna

Manufacturer
Direct_Rx
Effective date
2022-09-09
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:53:59

Label at a glance#

ProductDocusate Sod/Senna
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Docusate Sodium 50 mg
Sennosides 8.6 mg

OTC - PURPOSE SECTION

Stool softener

Stimulant laxative

WARNINGS SECTION

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

Ask a doctor before use if you have

stomach pain
nausea
vomiting
noticed a sudden change in bowel habits that lasts over 2 weeks

Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could

be signs of a serious condition.

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

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

OTHER SAFETY INFORMATION

each tablet contains: calcium 20 mg, sodium 3 mg
store at controlled room temperature
Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
product of India

INACTIVE INGREDIENT SECTION

cellulose, croscarmellose sodium, dicalcium phosphate, FD&C blue #2 lake, FD&C red #40 lake, hypromellose, magnesium stearate, PEG, silica, talc, titanium dioxide.

DOSAGE & ADMINISTRATION SECTION

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

adults and children 12 years and over take 2-4 tablets daily
children under 12 years of age ask a doctor

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center right away.

CLOSE

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use

OTC - STOP USE SECTION

you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could

be signs of a serious condition.

INDICATIONS & USAGE SECTION

relieves occasional constipation (irregularity)

this product generally produces bowel movement in 6 to 12 hours

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

72189-0378-6072189-0378-60

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
72189-378-60EA - Each72189-378327c27bc-bb4a-4e4a-8783-a252b725ee6912022-10-06
57896-304-01EA - Each57896-30415775618-2662-4fcc-8493-78a0d700e66312020-03-10
57896-304-10EA - Each57896-3047c8fa10f-02af-4f61-8986-3f5a3eba04c212020-08-06

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
72189-37872189-378-60
57896-304

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 13 matching rows.

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
Stool Softener with LaxativeDOCUSATE SODIUM AND SENNOSIDESGeri-Care Pharmaceutical Corp99fe8064-23f4-5d94-e053-2995a90a66412023-12-06WarningsExact identifier
ndc (product): 57896-304
07d9cb45-a5ba-a702-e063-6394a90a44a8e844057c-a7be-73d4-e053-2995a90ae9cb2023-10-16WarningsExact identifier
spl set id: e844057c-a7be-73d4-e053-2995a90ae9cb

Reported adverse events (FAERS/openFDA)#

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