Docusate Plus Senna

Manufacturer
Safecor Health, LLC
Effective date
2012-05-14
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 01:32:54

Label at a glance#

ProductDocusate Plus Senna
Active ingredientDOCUSATE SODIUM, SENNOSIDES A AND B
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 red #40 aluminum lake, hypromellose, magnesium stearate, microcrystalline cellulose, polyethylene glycol, sodium benzoate, stearic acid, titanium dioxide

OTC - PURPOSE SECTION

Purposes

stool softener, laxative

DOSAGE & ADMINISTRATION SECTION

Directions:

adults and children 12 years and over: 2-4 tablets once daily or in divided doses
children 6 to under 12 years: 1-2 tablets once daily or in divided doses
children 2 to under 6 years: 1/2-1 tablet once daily or in divided doses
children under 2 years: ask a doctor

INDICATIONS & USAGE SECTION

Uses:
Relieves occasional constipation (irregularity); generally causes bowel movement in 6-12 hours

WARNINGS SECTION

WARNINGS:

Do not use this product:

for longer than one week; if you are taking mineral oil; when abdominal pain, nausea or vomiting are present

Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts over two weeks

Ask a doctor or pharmacist before use if you are taking any other drug. Take this product two or more hours before or after other drugs. Laxatives may affect how other drugs work.

Stop use and ask a doctor if you have rectal bleeding; you fail to have a bowel movement after use of this product.

These may indicate a serious condition.

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

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Docusate Senna Box of 100 Robot-Rx Unit Dose Label
Docusate Senna Box of 100 Robot-Rx Unit Dose Label

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
49483-081-01EA - Each49483-081dbdee621-03c3-4233-a3c3-0f61f051156012015-08-04
49483-081-10EA - Each49483-0810e50bc4b-d558-4109-9045-614e8955a3bc12015-08-04

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
DOCUSATE SODIUMACTIVE INGREDIENTF05Q2T2JA02
SENNOSIDES A AND BACTIVE INGREDIENT1B5FPI42EN2
DOCUSATEACTIVE MOIETYM7P27195AG2
SENNOSIDES A AND BACTIVE MOIETY1B5FPI42EN2
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEINACTIVE INGREDIENTO7TSZ97GEP2
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ2
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U2
CROSCARMELLOSE SODIUMINACTIVE INGREDIENTM28OL1HH482
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA2
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO2
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I302
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A2
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU42
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU2
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP2
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP2

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
48433-30448433-304-01, 48433-304-10, 48433-304-75
49483-081

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 11 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
SODIUM BENZOATESODIUM BENZOATEOJ245FE5EUTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEDIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPTABLET, FILM COATED / ORAL953 mgExact identifier — unii+route+dosage form
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET, FILM COATED / ORAL176 mgExact identifier — unii+route+dosage form
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED / ORAL166 mgExact identifier — unii+route+dosage form
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET, FILM COATED / ORAL2.5 mgExact identifier — unii+route+dosage form
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, FILM COATED / ORAL96 mgExact identifier — unii+route+dosage form
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, FILM COATED / ORAL36 mgExact identifier — unii+route+dosage form
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET, FILM COATED / ORAL1 mgExact identifier — unii+route+dosage form
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, FILM COATED / ORAL992 mgExact identifier — unii+route+dosage form
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET, FILM COATED / ORAL582 mgExact identifier — unii+route+dosage form
CROSCARMELLOSE SODIUMCROSCARMELLOSE SODIUMM28OL1HH48TABLET, FILM COATED / ORAL330 mgExact identifier — unii+route+dosage form

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
SENNA TIME SDOCUSATE SODIUM-SENNOSIDESTIME CAP LABORATORIES, INCdc491692-8d3a-4ccd-a17d-4c630f1225952025-02-08WarningsExact identifier
ndc (product): 49483-081
32bea75d-3b7e-4caf-91c6-31cecf7c03029e0d04b2-bef8-4adf-aee4-c0fd2d62c84f2019-11-23WarningsExact identifier
spl set id: 9e0d04b2-bef8-4adf-aee4-c0fd2d62c84f

Reported adverse events (FAERS/openFDA)#

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