Active Ingredients And Purpose
OTC - PURPOSE SECTION
Purpose Stool softener Stimulant Laxative
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel) Docusate sodium 50 mg Sennosides 8.6 mg
Stool Softener + Stimulant Laxative
- Set ID
- 333cd1db-f313-4e5d-b1b9-c4a5290519a5
- Manufacturer
- Cardinal Health
- Effective date
- 2025-08-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 8
- Source
- full-release
- Hydrated at
- 2026-06-01 01:10:52
Key Label Information
Uses
Uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours
Warnings
WARNINGS SECTION
Warnings
Directions And Dosage
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 of age or over take 2-4 softgels daily children 6 to under 12 years of age take 1-2 softgels daily children 2 to under 6 years of age take upto 1 softgel daily children under 2 ask a doctor
Other Label Information
Other information
each softgel contains: calcium 2 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed
Inactive ingredients
Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide
Questions or Comments?
1-888-333-9792
PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton
Leader™ NDC 70000-0442-1 Stool Softener + Stimulant Laxative Docusate Sodium, 50 mg Sennosides, 8.6 mg COMPARE TO COLACE® 2-IN-1 active ingredients* 100% Money Back Guarantee 60 SOFTGELS Actual Size
Products
- STOOL SOFTENER AND STIMULANT LAXATIVE
- DOCUSATE SODIUM AND SENNOSIDES
- DOCUSATE
NDC Codes
Ingredients
| Name | UNII | Kind |
|---|---|---|
| POVIDONE K30 | U725QWY32X | IACT |
| WATER | 059QF0KO0R | IACT |
| CARBOXYMETHYLCELLULOSE SODIUM | K679OBS311 | IACT |
| SORBITOL | 506T60A25R | IACT |
| LECITHIN, SOYBEAN | 1DI56QDM62 | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| SENNOSIDES | 3FYP5M0IJX | ACTIB |
| SILICON DIOXIDE | ETJ7Z6XBU4 | IACT |
| YELLOW WAX | 2ZA36H0S2V | IACT |
| D&C RED NO. 33 | 9DBA0SBB0L | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
Complete SPL Sections
SPL UNCLASSIFIED SECTION
DRUG FACTS
OTC - PURPOSE SECTION
Purpose Stool softener Stimulant Laxative
OTC - ACTIVE INGREDIENT SECTION
Active ingredients (in each softgel) Docusate sodium 50 mg Sennosides 8.6 mg
Uses
relieves occasional constipation (irregularity) generally produces bowel movement in 6-12 hours
WARNINGS SECTION
Warnings
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 of age or over take 2-4 softgels daily children 6 to under 12 years of age take 1-2 softgels daily children 2 to under 6 years of age take upto 1 softgel daily children under 2 ask a doctor
Other information
each softgel contains: calcium 2 mg and sodium 3 mg store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) Keep tightly closed
Inactive ingredients
Aerosil, beeswax, FD&C Red No.33, FD&C Red No.40, gelatin, glycerin, light liquid paraffin, povidone (PVP K-30), purified water, sodium carboxymethylcellulose, sorbitol solution, soya lecithin, titanium dioxide
Questions or Comments?
1-888-333-9792
SPL UNCLASSIFIED SECTION
*This product is not manufactured or distributed by Purdue Products L.P., owner of the registered trademark Colace® 2-IN-1. © 2019 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. DISTRIBUTED BY CARDINAL HEALTH, DUBLIN, OHIO 43017 www.myleader.com 1-800-200-6313 Made in India All LEADER™ Brand Products Have A Return to place of purchase if not satisfied. 100% Money Back Guarantee TAMPER EVIDENT: DO NOT USE IF PRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING. KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
PRINCIPAL DISPLAY PANEL - 60 Capsule Bottle Carton
Leader™ NDC 70000-0442-1 Stool Softener + Stimulant Laxative Docusate Sodium, 50 mg Sennosides, 8.6 mg COMPARE TO COLACE® 2-IN-1 active ingredients* 100% Money Back Guarantee 60 SOFTGELS Actual Size
Source Document
Official SPL XML cached by FDA.report · DailyMed PDF
- XML object
- dailymed/333cd1db-f313-4e5d-b1b9-c4a5290519a5/3ca38df4-07aa-a25b-e063-6294a90a29e6.xml
- XML SHA-256
- 7b7f768e5ce8dd72a1e0633fa0633b2751ea95831f93fed7eb5c5d70c3c8568e
- XML bytes
- 30233
Legacy File Index
| Folder | File | Date |
|---|---|---|
| otc | 3ca38df4-07aa-a25b-e063-6294a90a29e6.xml | 2025-08-20 |
| otc | 292edb21-0ca3-54a7-e063-6294a90a8c6c.xml | 2024-12-15 |
| otc | 0bdd371a-6c4d-f363-e063-6394a90a7f7a.xml | 2023-12-07 |
| otc | edc408cf-9cc7-1550-e053-2995a90ad447.xml | 2022-11-19 |
| otc | cfc06ae2-525b-9db5-e053-2995a90a04cd.xml | 2021-11-03 |
| otc | c4cec616-df22-bc76-e053-2a95a90abd57.xml | 2021-06-16 |
| otc | b5e28c44-c006-e82e-e053-2a95a90a6204.xml | 2020-12-08 |
| otc | 80b6f35b-11a8-1abb-e053-2991aa0a7409.xml | 2019-01-31 |
| otc | 80b73de0-a1f1-20af-e053-2a91aa0add02.jpg | 2019-01-31 |
| otc | LDR_Stool Softener Plus Laxative Stimulant_60ct_Carton_SPR_25715110_V2.jpg | 2019-01-31 |