FDA.reportPublic FDA data

Sennosides / Docusate Sodium

Manufacturer
Cardinal Health 107, LLC
Effective date
2026-05-05
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 01:56:47

Label at a glance#

ProductSennosides, Docusate Sodium
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

• 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 6 to under 12 years of age take 1-2 tablets daily children 2 to under 6 years of age take up to 1 tablet daily children under 2 years ask a doctor

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredients (in each tablet)

Docusate sodium 50 mg
Sennosides 8.6 mg

OTC - PURPOSE SECTION

Purposes

Stool softener
Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

.

Do not use

OTC - DO NOT USE SECTION

  • laxative products for longer than 1 week unless told to do so by a doctor
  • if you are presently taking mineral oil, unless told to do so 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 lasts over two weeks

Stop use and ask a doctor if

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.

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 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 6 to under 12 years of age

take 1-2 tablets daily

children 2 to under 6 years of age

take up to 1 tablet daily

children under 2 years

ask a doctor

Other information

OTHER SAFETY INFORMATION

  • each tablet contains: calcium 5 mg
  • Store in a dry place at 15° – 30°C (59° – 86°F).

Inactive Ingredients

INACTIVE INGREDIENT SECTION

corn starch, croscarmellose sodium, dibasic calcium phosphate dihydrate, FD&C blue #1 lake, FD&C red #40 lake, FD&C yellow #6 lake, hypromellose, magnesium stearate, maltodextrin, microcrystalline cellulose, mineral oil, polyethylene glycol, sodium benzoate, sodium lauryl sulfate, stearic acid, talc, titanium dioxide.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-231-4670

SPL UNCLASSIFIED SECTION

Keep this carton for complete product information

Tamper Evident:

Do not use if sealed blister units are broken or damaged.

Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
www.majorpharmaceuticals.com

Overbagged with 10 tablets per bag, NDC 55154-0195-0

WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.

Distributed By:

Cardinal Health

Dublin, OH 43017

L6083711-11025 / L6083711-21025

Rev. 02/24

M-29

Re-order No. 701390

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 55154-0195-0

Sennosides/Docusate Sodium

8.6 mg/50 mg

Stool Softener/Stimulant Laxative

10 TABLETS

8.6mg/50mg bag label
8.6mg/50mg bag label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN2
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD2
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY2

Product Linked Resources#

Resource, Code type, Value table
ResourceCode typeValueEquivalent identifiersSource image
BarcodeEAN-130055154019507GTIN-13: 0055154019507
EAN-13: 0055154019507
GTIN-12: 055154019507
UPC-A: 055154019507
GTIN storage (14 digits): 00055154019507		1A21B07A-263C-41A4-BA0C-AD2DC5A295D7-00.jpg

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
55154-0195-0Sennosides, Docusate Sodium1 in 1 BAGTABLET, FILM COATED12
55154-0195-0Sennosides, Docusate Sodium10 in 1 BLISTER PACKTABLET, FILM COATED102

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-7440-61EA - Each0904-7440a75ec58c-9565-4888-a134-1c79c57b92bd12024-08-12

Products#

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

DailyMed product names page 1 of 1 · 21 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
55154-019555154-0195-0
0904-7440

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 19 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
STARCH, CORNO8232NY3SJIACT
CROSCARMELLOSE SODIUMM28OL1HH48IACT
DIBASIC CALCIUM PHOSPHATE DIHYDRATEO7TSZ97GEPIACT
FD&C BLUE NO. 1 ALUMINUM LAKEJ9EQA3S2JMIACT
FD&C RED NO. 40 ALUMINUM LAKE6T47AS764TIACT
FD&C YELLOW NO. 6 ALUMINUM LAKEGYP6Z2JR6QIACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
MAGNESIUM STEARATE70097M6I30IACT
MALTODEXTRIN7CVR7L4A2DIACT
MICROCRYSTALLINE CELLULOSEOP1R32D61UIACT
LIGHT MINERAL OILN6K5787QVPIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM LAURYL SULFATE368GB5141JIACT
STEARIC ACID4ELV7Z65APIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
12025-11-12monthly-update2026-06-03 17:40:11

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, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMCardinal Health 107, LLC1a21b07a-263c-41a4-ba0c-ad2dc5a295d72026-05-05WarningsExact identifier
ndc (package): 55154-0195-0
ndc (product): 55154-0195
ndc11 (package): 55154019500
spl id: a7d75ea6-df85-4047-951c-d30223309645
spl set id: 1a21b07a-263c-41a4-ba0c-ad2dc5a295d7
Sennosides, Docusate SodiumSENNOSIDES, DOCUSATE SODIUMMajor Pharmaceuticals1768b470-2808-fa46-e063-6394a90ac8d92024-05-01WarningsExact identifier
ndc (product): 0904-7440

Reported adverse events (FAERS/openFDA)#

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