Indications and uses
• relieves occasional constipation (irregularity) • this product generally produces a bowel movement within 12 to 72 hours.
docusate sodium stool softener laxative
- Manufacturer
- Cardinal Health 107, LLC
- Effective date
- 2026-07-20
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 1
- Source
- daily-update
- Hydrated at
- 2026-08-01 05:10:12
Label at a glance#
ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure10 sections
Dosage and administration
• take only by mouth • 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 5 mg (very low sodium) • store at controlled room temperature 20–25°C (68–77°F) • protect from light, heat and moisture
Contacts and useful links#
Websitewww.major-rugby.com
www.major-rugby.com
www.major-rugby.comLabel contents#
Full prescribing information#
Active ingredient (in each softgel)
Docusate Sodium 100 mg
Purpose
Stool softener laxative
Uses
• relieves occasional constipation (irregularity)
• this product generally produces a bowel movement within 12 to 72 hours.
Warnings
Do not use
• if you are presently taking mineral oil, unless told to do so by a doctor
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 only by mouth • take softgels with a full glass (8 oz) of water
adults and children 12 years of age | 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 |
children under 6 years of age | ask a doctor |
Other information
• each softgel contains: sodium 5 mg (very low sodium)
• store at controlled room temperature 20–25°C (68–77°F)
• protect from light, heat and moisture
Inactive ingredients
FD&C Red No.40, FD&C Yellow No.6, gelatin, glycerin, polyethylene glycol 400, propylene glycol, purified water, sorbitol sorbitan solution
Questions or comments?
1(888) 577-8033
SPL UNCLASSIFIED SECTION
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
Overbagged with 10 softgels per bag, NDC 55154-0578-0
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
L61399840626
www.major-rugby.com
Made in India
CT0904760961
REV.00-092025
Rev. 10/25 M-173 Re-order No. 701455
READ AND KEEP OUTER CARTON FOR COMPLETE
PRODUCT WARNINGS AND INFORMATION
TAMPER EVIDENT: DO NOT USE IF PACKAGE IS OPENED OR IF BLISTER
UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING.
Principal Display Panel
NDC 55154-0578-0
DOCUSATE SODIUM 100 mg
Stool Softener Laxative
10 SOFTGELS
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0055154057806 | GTIN-13: 0055154057806 EAN-13: 0055154057806 GTIN-12: 055154057806 UPC-A: 055154057806 GTIN storage (14 digits): 00055154057806 | FC5E82B6-E25C-4686-9781-2205819685F5-00.jpg |
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0904-7609-61 | EA - Each | 0904-7609 | 2b039e75-f18f-4348-8026-08491b45d8bc | 1 | 2026-05-22 |
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium
- DOCUSATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN, UNSPECIFIED
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- SORBITAN
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 55154-0578 | 55154-0578-0 |
| 0904-7609 |
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 |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| SORBITAN | 6O92ICV9RU | 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 |
|---|---|---|---|---|---|---|
| Docusate Sodium | DOCUSATE SODIUM | Cardinal Health 107, LLC | fc5e82b6-e25c-4686-9781-2205819685f5 | 2026-07-20 | Warnings | 55154-0578-0 55154-0578 55154057800 fc5e82b6-e25c-4686-9781-2205819685f5 fc5e82b6-e25c-4686-9781-2205819685f5 |
| Docusate Sodium | DOCUSATE SODIUM | Major Pharmaceuticals | 3e8321cf-7eda-d70c-e063-6394a90a35a5 | 2025-12-10 | Warnings | 0904-7609 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.