FDA.reportPublic FDA data

STOOL SOFTENER AND STIMULANT LAXATIVE

Manufacturer
Cardinal Health
Effective date
2025-08-18
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 01:10:52

Label at a glance#

ProductSTOOL SOFTENER AND STIMULANT LAXATIVE
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure11 sections

Indications and uses

relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 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 of age or over  take 2-4 softgels daily  children 6 to under 12 years of age        take 1-2 softgels daily  children 2 to under 6 years of age     take upto 1 softgel daily  children under 2  ask a doctor

Storage and handling

each softgel contains: calcium 2 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

DRUG FACTS

OTC - PURPOSE SECTION

Purpose
Stool softener
Stimulant Laxative

OTC - ACTIVE INGREDIENT SECTION

Active ingredients
(in each softgel) 
Docusate sodium 50 mg
Sennosides 8.6 mg

Uses

INDICATIONS & USAGE SECTION

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

WARNINGS SECTION

Warnings

OTC - DO NOT USE SECTION

Do not use

  • 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

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have

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

OTC - STOP USE SECTION

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

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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 (1800-222-1222) 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 of age or over take 2-4 softgels daily
 children 6 to under 12 years of age       take 1-2 softgels daily
 children 2 to under 6 years of age    take upto 1 softgel daily
 children under 2 ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • each softgel contains: calcium 2 mg and sodium 3 mg
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • Keep tightly closed

Inactive ingredients

INACTIVE INGREDIENT SECTION

Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide

Questions or Comments?

OTC - QUESTIONS SECTION

1-888-333-9792

SPL UNCLASSIFIED SECTION

*This product is not manufactured or distributed by Purdue
Products L.P., owner of the registered trademark Colace® 2-IN-1.


© 2019 Cardinal Health. All Rights Reserved. CARDINAL HEALTH,
the Cardinal Health LOGO, LEADER, and the Leader LOGO are
trademarks or registered trademarks of Cardinal Health. All other
marks are the property of their respective owners.

DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017
www.myleader.com 1-800-200-6313
Made in India

All LEADER™ Brand Products Have A
Return to place of purchase if not satisfied.
100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY
SEAL UNDER CAP IS BROKEN OR MISSING.

KEEP OUTER CARTON FOR COMPLETE
WARNINGS AND PRODUCT INFORMATION

PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Leader™

NDC 70000-0442-1

Stool
Softener +
Stimulant
Laxative

Docusate Sodium, 50 mg
Sennosides, 8.6 mg

COMPARE TO
COLACE®
2-IN-1
active ingredients*

100% Money
Back Guarantee

60 SOFTGELS 

Actual Size

image descriptionimage description

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
6084a4f4-5437-c9a5-caec-5361ee075a59Product name120140508
90c5639a-61b0-88d6-ddcf-21888e94869aProduct name120140508
9514609b-a2a9-f8ec-6ba6-3f8e5ee89877Product name120140508

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70000-0442-1STOOL SOFTENER AND STIMULANT LAXATIVE1 in 1 CARTONCAPSULE, GELATIN COATED18
70000-0442-1STOOL SOFTENER AND STIMULANT LAXATIVE60 in 1 BOTTLE, PLASTICCAPSULE, GELATIN COATED608

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70000-0442-1EA - Each70000-0442fdb49bc1-e7ea-4562-80b8-0715227258ba12019-11-12

Products#

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

DailyMed product names page 1 of 1 · 18 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-044270000-0442-1

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
POVIDONE K30U725QWY32XIACT
WATER059QF0KO0RIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SORBITOL506T60A25RIACT
LECITHIN, SOYBEAN1DI56QDM62IACT
TITANIUM DIOXIDE15FIX9V2JPIACT
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
YELLOW WAX2ZA36H0S2VIACT
D&C RED NO. 339DBA0SBB0LIACT
FD&C RED NO. 40WZB9127XOAIACT
GELATIN2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
LIGHT MINERAL OILN6K5787QVPIACT

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
3ca38df4-07aa-a25b-e063-6294a90a29e6333cd1db-f313-4e5d-b1b9-c4a5290519a52025-08-18WarningsExact identifier
spl id: 3ca38df4-07aa-a25b-e063-6294a90a29e6
spl set id: 333cd1db-f313-4e5d-b1b9-c4a5290519a5

Reported adverse events (FAERS/openFDA)#

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