Indications and uses
• for relief of occasional constipation (irregularity) • This generally produces a bowel movement within 12 to 72 hours.
Docusate Sodium - Stool Softener Laxative
- Manufacturer
- Cardinal Health 107, LLC
- Effective date
- 2026-07-28
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 6
- Source
- daily-update
- Hydrated at
- 2026-08-08 02:01:59
Label at a glance#
ProductDocusate Sodium - Stool Softener Laxative
Active ingredientDOCUSATE SODIUM
Label structure10 sections
Dosage and administration
• take softgels with a full glass (8 oz) of water adults and children 12 years of age and older take 1 to 3 softgels daily or as directed by a doctor. This dose may be taken as a single daily dose or in divided doses. children 6 to under 12 years of age take 1 softgel daily or as directed by a doctor children under 6 years of age ask a doctor
Storage and handling
• each softgel contains: sodium 10 mg (very low sodium) • store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).
Contacts and useful links#
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Docusate Sodium 100 mg
Purpose
Stool softener laxative
Uses
• for relief of occasional constipation (irregularity)
• This generally produces a bowel movement within 12 to 72 hours.
Warnings
Ask a doctor before use if you have
• abdominal pain, nausea, or vomiting
• a sudden change in bowel habits that lasts over 14 days
Ask a doctor or pharmacist before use if you are presently taking mineral oil
Stop use and ask a doctor if
• you have rectal bleeding or no bowel movement after using this product.
These can be signs of a serious condition
• you need to use a laxative for more than 1 week
If pregnant or breast-feeding, ask a health care professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children
Overdose Warning: In case of overdose, get medical help or contact a Poison Control Center right away (1-800-222-1222). Prompt medical attention is critical for adults as well as children even if you do not notice any signs or symptoms.
Directions
• take softgels with a full glass (8 oz) of water
adults and children 12 years of age and older | take 1 to 3 softgels daily or as directed |
children 6 to under 12 years of age | take 1 softgel daily or as directed by a doctor |
children under 6 years of age | ask a doctor |
Other information
• each softgel contains: sodium 10 mg (very low sodium)
• store at 25°C (77°F) in a dry place. Avoid excessive heat 40°C (140°F).
Inactive ingredients
edible white ink, FD&C red no. 40, FD&C yellow no. 6, gelatin, glycerin, isopropyl alcohol, light mineral oil, medium chain triglycerides, polyethylene glycol, propylene glycol, purified water, sorbitol sorbitan solution
Questions or comments?
(800)616-2471
SPL UNCLASSIFIED SECTION
MAJOR ®
Unit Dose
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING
READ AND KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION
Distributed by:
MAJOR ®PHARMACEUTICALS
Indianapolis, IN 46268
Overbagged with 10 softgels per bag, NDC 55154-3369-0
WARNING: This Unit Dose package is not child resistant and is Intended for Institutional Use Only. Keep this and all drugs out of the reach of children.
Distributed By:
Cardinal Health
Dublin, OH 43017
L57466800124
Product of UAE
Packaged and Quality Assured in the USA
CT0904718361
REV.01-032022
Rev. 07/21 | M-173 | Re-order No. 701293 |
Principal Display Panel
NDC 55154-3369-0
DOCUSATE SODIUM 100 mg
Stool Softener Laxative
10 SOFTGELS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0055154336901 | GTIN-13: 0055154336901 EAN-13: 0055154336901 GTIN-12: 055154336901 UPC-A: 055154336901 GTIN storage (14 digits): 00055154336901 | 362b3bf1-c0d0-4dee-a2c9-093d772a8b56-00.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7183-61 | EA - Each | 0904-7183 | da67df6d-a60f-4a39-8851-7609176262e6 | 1 | 2021-10-08 |
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium - Stool Softener Laxative
- Docusate Sodium
- DOCUSATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- GLYCERIN
- ISOPROPYL ALCOHOL
- LIGHT MINERAL OIL
- MEDIUM-CHAIN TRIGLYCERIDES
- POLYETHYLENE GLYCOL, UNSPECIFIED
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55154-3369 | 55154-3369-0 |
| 0904-7183 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| GELATIN, UNSPECIFIED | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| LIGHT MINERAL OIL | N6K5787QVP | IACT |
| MEDIUM-CHAIN TRIGLYCERIDES | C9H2L21V7U | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
Source Document#
Older Hydrated Versions#
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 5 | 2025-10-02 | full-release | 2026-06-01 01:15:51 |
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 |
|---|---|---|---|---|---|---|
| Docusate Sodium - Stool Softener Laxative | DOCUSATE SODIUM | Cardinal Health 107, LLC | b5e4b14d-bf11-4309-bf6d-65ee9d877a24 | 2026-07-28 | Warnings | 55154-3369-0 55154-3369 55154336900 e7438297-555e-458e-b889-b1ca82d34d96 b5e4b14d-bf11-4309-bf6d-65ee9d877a24 |
| Docusate Sodium - Stool Softener Laxative | DOCUSATE SODIUM | Major Pharmaceuticals | cc8d1556-f108-4166-837c-48f81152877e | 2026-05-12 | Warnings | 0904-7183 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.