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LEADER Senna Plus Stool Softener Laxative SOFTGEL

LEADER Senna Plus Stool Softener Laxative SOFTGELS

Approved
Approval ID

6efe36a9-051d-435e-8965-9339bb41bf33

Product Type

HUMAN OTC DRUG LABEL

Effective Date

Sep 3, 2025

Manufacturers
FDA

Cardinal Health 110, LLC. DBA Leader

DUNS: 063997360

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Docusate sodium, Sennosides

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code70000-0685
Application NumberM007
Product Classification
M
Marketing Category
C200263
G
Generic Name
Docusate sodium, Sennosides
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 3, 2025
FDA Product Classification

INGREDIENTS (14)

SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
FD&C YELLOW NO. 6Inactive
Code: H77VEI93A8
Classification: IACT
GELATIN, UNSPECIFIEDInactive
Code: 2G86QN327L
Classification: IACT
GLYCERINInactive
Code: PDC6A3C0OX
Classification: IACT
POLYETHYLENE GLYCOL 400Inactive
Code: B697894SGQ
Classification: IACT
POVIDONE, UNSPECIFIEDInactive
Code: FZ989GH94E
Classification: IACT
PROPYLENE GLYCOLInactive
Code: 6DC9Q167V3
Classification: IACT
WATERInactive
Code: 059QF0KO0R
Classification: IACT
SORBITOLInactive
Code: 506T60A25R
Classification: IACT
SORBITANInactive
Code: 6O92ICV9RU
Classification: IACT
TITANIUM DIOXIDEInactive
Code: 15FIX9V2JP
Classification: IACT
YELLOW WAXInactive
Code: 2ZA36H0S2V
Classification: IACT
DOCUSATE SODIUMActive
Quantity: 50 mg in 1 1
Code: F05Q2T2JA0
Classification: ACTIB
SENNOSIDESActive
Quantity: 8.6 mg in 1 1
Code: 3FYP5M0IJX
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 7/25/2024

Packaging

Senna Plus

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 7/17/2024

Uses

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

OTC - ACTIVE INGREDIENT SECTION

LOINC: 55106-9Updated: 7/17/2024

Active ingredients (in each softgel)

Docusate sodium 50 mg
Sennosides 8.6 mg

OTC - PURPOSE SECTION

LOINC: 55105-1Updated: 7/17/2024

Purpose

Stool softener
Laxative

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 7/26/2024

COMPARE TO SENOKOT-S**®**** active ingredients***

Dual Action

Standardized Senna Concentrate

All LEADER™ Brand Products Have A100% 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-S ®

©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.

WARNINGS SECTION

LOINC: 34071-1Updated: 7/17/2024

Warnings

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 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.

Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 7/26/2024

Directions

• 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 SECTION

LOINC: 44425-7Updated: 7/17/2024

Other information

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

INACTIVE INGREDIENT SECTION

LOINC: 51727-6Updated: 7/17/2024

Inactive ingredients

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

OTC - QUESTIONS SECTION

LOINC: 53413-1Updated: 7/17/2024

Questions or comments?

Call1-800-200-6313

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