Leader Stool Softener Plus Stimulant Laxative SOFTGEL

Manufacturer
Cardinal Health 110, LLC. DBA Leader
Effective date
2024-01-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 21:12:16

Label at a glance#

ProductLeader Stool Softener Plus Stimulant Laxative SOFTGEL
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 softgels daily  children 6 to under 12 years and over  take 1-2 softgels daily  children under 6 years of age  ask a doctor

Storage and handling

• each softgel contains : sodium 4 mg • store at room temperature between 20°-25°C (68°-77°F)

Label contents#

Full prescribing information#

Active ingredients (in each softgel)

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 bowel movement in 6 to 12 hours

Warnings

WARNINGS 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

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.

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 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 softgels daily
 children 6 to under 12 years and over take 1-2 softgels daily
 children under 6 years of age ask a doctor

Other information

STORAGE AND HANDLING SECTION

• each softgel contains: sodium 4 mg
• store at room temperature between 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C red #40, gelatin, glycerin, polyethylene glycol 400, povidone, propylene glycol, purified water, sorbitol sorbitan solution, titanium dioxide, yellow bees wax

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-200-6313

SPL UNCLASSIFIED SECTION

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

100% Money Back Guarantee

DISTRIBUTE BY CARDINAL HEALTH
DUBLIN, OHIO 43017
www. myleader.com 1-800-200-6313
Essential to Care™ since 1979

Product of India

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

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

*This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark COLACE® 2-IN-1.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARDINAL-9030CARDINAL-9030

Products#

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DailyMed product names page 1 of 1 · 17 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-903070000-9030-6

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

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
028d3c2d-3eb4-4044-b308-7ce30b32b6e47eeeb95d-7754-43b9-a74e-3ee900b71b062024-02-23WarningsExact identifier
spl set id: 7eeeb95d-7754-43b9-a74e-3ee900b71b06

Reported adverse events (FAERS/openFDA)#

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