FDA.reportPublic FDA data

Leader Senna Plus Stool Softener 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 21:12:19

Label at a glance#

ProductLeader Senna Plus Stool Softener Laxative SOFTGEL
Active ingredientDOCUSATE SODIUM, SENNOSIDES
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: 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
Laxative

Uses

INDICATIONS & USAGE SECTION

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

Warnings

WARNINGS SECTION

Do not use • if you are now taking mineral oil, unless directed by a doctor • 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 if you 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: sodium 4 mg
• store at room temperature between 20°-25°C (68°-77°F)

Inactive ingredients

INACTIVE INGREDIENT SECTION

colloidal silicon dioxide, FD&C yellow #6, 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 SENOKOT-S® active ingredients* 

Dual Action
Standardized Senna Concentrate

Overnight, gentle laxative

100% Money Back Guarantee

*This product is not manufactured or distributed by Avrio Health L.P., owner of the registered trademark Senokot-S®

©2024 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.

DISTRIBUTE 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

Packaging

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

CARDINAL-9020CARDINAL-9020

Products#

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

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

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-902070000-9020-6

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 14 matching rows.

Name, UNII, Kind table
NameUNIIKind
DOCUSATE SODIUMF05Q2T2JA0ACTIB
SENNOSIDES3FYP5M0IJXACTIB
SILICON DIOXIDEETJ7Z6XBU4IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN, UNSPECIFIED2G86QN327LIACT
GLYCERINPDC6A3C0OXIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
WATER059QF0KO0RIACT
SORBITOL506T60A25RIACT
SORBITAN6O92ICV9RUIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
YELLOW WAX2ZA36H0S2VIACT

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
adf14292-54fc-4786-916f-c28aedc90020d41b346b-b425-4121-90c6-2fcddccd495c2024-02-23WarningsExact identifier
spl set id: d41b346b-b425-4121-90c6-2fcddccd495c

Reported adverse events (FAERS/openFDA)#

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