FDA.reportPublic FDA data

Stool Softener plus Stimulant Laxative

Manufacturer
CARDINAL HEALTH, 110 DBA LEADER | Pharbest Pharmaceuticals, Inc.
Effective date
2026-03-06
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 01:49:18

Label at a glance#

ProductStool Softener plus Stimulant Laxative
Active ingredientSENNOSIDES, DOCUSATE SODIUM
Label structure9 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces a 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 upto 1 tablet daily children under 2  ask a doctor

Storage and handling

each tablet contains:  calcium 10 mg, sodium 5 mg, Very Low Sodium store at 20-25°C (68-77°F); excursions permitted between 15-30 o C (59-86 o F)

Label contents#

Full prescribing information#

Active Ingredients (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

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 2 weeks

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

These could be sings 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 (1-800-222-1222).

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 upto 1 tablet daily

children under 2 

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each tablet contains: calcium 10 mg, sodium 5 mg, Very Low Sodium
  • store at 20-25°C (68-77°F); excursions permitted between 15-30oC (59-86oF)

Inactive ingredients

INACTIVE INGREDIENT SECTION

croscarmellose sodium, dicalcium phosphate, FD&C Red #40, magnesium stearate, microcrystalline cellulose, polyethylene glycol, polyvinyl alcohol, sodium benzoate, talc, titanium dioxide

Questions?

OTC - QUESTIONS SECTION

(866) 562-2756 (Mon-Fri 8 AM to 4 PM EST)

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LEADER TM

NDC 70000-0526-1

Stool Softener +

Stimulant Laxative

Docusate Sodium, 50 mg

Sennosides, 8.6 mg

COMPARE TO

COLACE® 2-IN-1

active ingredients*

100% Money

Back Guarantee

100 TABLETS

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Colace® 2-IN-1.

Dist. by CAH, Dublin, OH 43017 ©2025 Cardinal Health

CIN 5566153 REV. 07/25

Leader Stool Softener + Stimulant Laxative Tablet 100 ct. Product LabelLeader Stool Softener + Stimulant Laxative Tablet 100 ct. Product Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
998740sennosides 8.6 MG / docusate sodium 50 MG Oral TabletPSN5
998740docusate sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSCD5
998740DOSS Sodium 50 MG / sennosides, USP 8.6 MG Oral TabletSY5

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0526-1Stool Softener plus Stimulant Laxative100 in 1 BOTTLE, PLASTICTABLET, FILM COATED1005
70000-0526-2Stool Softener plus Stimulant Laxative200 in 1 BOTTLE, PLASTICTABLET, FILM COATED2005

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0526-1EA - Each70000-05264cfc67a7-a920-4617-b601-6a7e5d00239012020-02-13

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
70000-052670000-0526-1, 70000-0526-2

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
SENNOSIDES3FYP5M0IJXACTIB
DOCUSATE SODIUMF05Q2T2JA0ACTIB
CROSCARMELLOSE SODIUMM28OL1HH48IACT
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATEO7TSZ97GEPIACT
FD&C RED NO. 40WZB9127XOAIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ALCOHOL, UNSPECIFIED532B59J990IACT
SODIUM BENZOATEOJ245FE5EUIACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
42025-12-23monthly-update2026-06-03 17:46:38

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
Stool Softener plus Stimulant LaxativeDOCUSATE SODIUM 50 MG AND SENNOSIDES 8.6 MGCARDINAL HEALTH, 110 DBA LEADER3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce2026-03-06WarningsExact identifier
ndc (package): 70000-0526-1
ndc (package): 70000-0526-2
ndc (product): 70000-0526
ndc11 (package): 70000052601
ndc11 (package): 70000052602
spl id: b33fb5f0-197e-4a91-b324-af6a97c29f53
spl set id: 3fd9ba76-42f8-4ebe-b1bc-f81f08e702ce

Reported adverse events (FAERS/openFDA)#

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