FDA.reportPublic FDA data

LEADER Regular Strength Senna Laxative SOFTGEL

Manufacturer
Cardinal Health 110, LLC. DBA Leader | SOFTGEL HEALTHCARE PRIVATE LIMITED
Effective date
2025-09-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
legacy-cache
Hydrated at
2026-08-01 20:34:43

Label at a glance#

ProductLEADER Regular Strength Senna Laxative SOFTGEL
Active ingredientSENNOSIDES
Label structure10 sections

Indications and uses

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

Dosage and administration

• take preferably at bedtime or as directed by a doctor Age  Starting Dosage  Maximum Dosage   adults and children 12 years of age and over  2 softgels once a day  4 softgels twice a day  children 6 to under 12 years  1 softgel once a day  2 softgels twice a day  children under 6 years of age  ask a doctor  ask a doctor

Storage and handling

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

Label contents#

Full prescribing information#

Active ingredient (in each softgel)

OTC - ACTIVE INGREDIENT SECTION

Sennosides 8.6 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use
• laxative products for longer than 1 week unless directed by a doctor

Ask a doctor before use if you have
• stomach pain • nausea • vomiting • noticed a sudden change in bowel habits that continues over a period of 2 weeks

Stop use and ask a doctor ifyou have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 reach of children.In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

• take preferably at bedtime or as directed by a doctor

Age Starting Dosage Maximum Dosage 
 adults and children 12 years of age and over 2 softgels once a day 4 softgels twice a day
 children 6 to under 12 years 1 softgel once a day 2 softgels twice a day
 children under 6 years of age ask a doctor ask a doctor

Other information

STORAGE AND HANDLING SECTION

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

Inactive ingredients

INACTIVE INGREDIENT SECTION

black iron oxide, fumaric acid, gelatin, glycerin, lecithin liquid, methyl paraben, purified water, red iron oxide, sorbitol 70% solution, soybean oil, yellow bees wax

Questions or comments?

OTC - QUESTIONS SECTION

Call 1-800-200-6313

SPL UNCLASSIFIED SECTION

Standardized Senna Concentrate

Natural Vegetable Laxative Ingredient

COMPARE TO SENOKOT ®REGULAR STRENGTH active ingredient*

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

CardinalHealth ™

DISTRIBUTED BY CARDINAL HEALTH
DUBLIN, OHIO 43017

www.myleader.com
1-800-200-6313
Essential to Care™ since 1979

Product of India

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

READ AND KEEP OUTER CARTON FOR COMPLETE PRODUCT WARNINGS AND INFORMATION

Overnight, gentle laxative

*This product is not manufactured or distributed by Atlantis Consumer Healthcare Inc., owner of the registered trademark Senokot®.
©2024 Cardinal Health. CARDINAL HEALTH, the Cardinal Health LOGO, ESSENTIAL TO CARE, LEADER, and the LEADER LOGO are trademarks or registered trademarks of Cardinal Health. All other marks are the property of their respective owners.

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Laxative SoftgelLaxative Softgel

Products#

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

DailyMed product names page 1 of 1 · 13 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-068670000-0686-1

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
FERROSOFERRIC OXIDEXM0M87F357IACT
FUMARIC ACID88XHZ13131IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
SOYBEAN LECITHIN1DI56QDM62IACT
METHYLPARABENA2I8C7HI9TIACT
WATER059QF0KO0RIACT
FERRIC OXIDE RED1K09F3G675IACT
SORBITOL SOLUTION8KW3E207O2IACT
SOYBEAN OIL241ATL177AIACT
YELLOW WAX2ZA36H0S2VIACT
SENNOSIDES3FYP5M0IJXACTIB

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
3e4be1e0-488c-3d2e-e063-6294a90a51faa2848981-d20f-4f37-b855-819d9a88d3a62025-09-08WarningsExact identifier
spl set id: a2848981-d20f-4f37-b855-819d9a88d3a6

Reported adverse events (FAERS/openFDA)#

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