Indications and uses
• relieves occasional constipation (irregularity) • generally produces bowel movement in 6 to 12 hours
LEADER Stool Softener Plus Stimulant Laxative SOFTGEL
- Manufacturer
- Cardinal Health 110, LLC. DBA Leader
- Effective date
- 2024-07-16
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 20:57:59
Label at a glance#
ProductLEADER Stool Softener Plus Stimulant Laxative SOFTGEL
Active ingredientDOCUSATE SODIUM, SENNOSIDES
Label structure10 sections
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)
Contacts and useful links#
Websitewww.myleader.com
www.myleader.com
www.myleader.comLabel contents#
Full prescribing information#
Active ingredients (in each softgel)
Docusate sodium 50 mg
Sennosides 8.6 mg
Purpose
Stool softener
Stimulant laxative
Uses
• relieves occasional constipation (irregularity)
• generally produces bowel movement in 6 to 12 hours
Warnings
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
• 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
• each softgel contains: sodium 4 mg
• store at room temperature between 20°-25°C (68°-77°F)
Inactive ingredients
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?
Call 1-800-200-6313
SPL UNCLASSIFIED SECTION
COMPARE TO COLACE® 2-IN-1 active ingredients*
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 43017www.myleader.com
1-800-200-6313
Essential to Care™ Since 1979
Product of India
©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.
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 Atlantis Consumer Healthcare Inc., owner of the registered trademark COLACE® 2-IN-1.
Packaging
DailyMed Dashboard NDC Coverage#
| NDC | Dashboard title | SPL version | Validation | Dashboard ZIP |
|---|---|---|---|---|
| 70000-0684 | LEADER STOOL SOFTENER PLUS STIMULANT LAXATIVE SOFTGEL (DOCUSATE SODIUM, SENNOSIDES) CAPSULE, LIQUID FILLED [CARDINAL HEALTH 110, LLC. DBA LEADER] | 1 | Unmatched | 20240730_0b2548d5-7346-43c8-b953-5842e8678d34.zip |
Products#
Every source-derived product name is available through these pages.
- LEADER Stool Softener Plus Stimulant Laxative SOFTGEL
- Docusate sodium, Sennosides
- DOCUSATE SODIUM
- DOCUSATE
- SENNOSIDES
- SILICON DIOXIDE
- FD&C RED NO. 40
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- POVIDONE, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
- TITANIUM DIOXIDE
- YELLOW WAX
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 70000-0684 | 70000-0684-1 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| SENNOSIDES | 3FYP5M0IJX | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| POVIDONE, UNSPECIFIED | FZ989GH94E | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
Source Document#
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| 45a1661e-a42d-d175-e063-6294a90a272b | 0b2548d5-7346-43c8-b953-5842e8678d34 | 2025-12-10 | Warnings | 0b2548d5-7346-43c8-b953-5842e8678d34 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.