Indications and uses
• relieves occasional constipation (irregularity) • this product generally produces a bowel movement within 12 to 72 hours.
Docusate Sodium
- Manufacturer
- Major Pharmaceuticals
- Effective date
- 2025-12-10
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- full-release
- Hydrated at
- 2026-06-01 01:26:15
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 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 |
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
NDC 0904-7609-61
MAJOR® docusate sodium
docusate sodium 100 mg
stool softener
laxative
• stimulant-free
• relief of occasional constipation
100 softgels
(10x10) unit dose
Distributed by:
MAJOR® PHARMACEUTICALS
Indianapolis, IN 46268
(800) 616-2471
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.
Packaging
DailyMed RxNorm Mappings#
Product Linked Resources#
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | EAN-13 | 0309047609611 | GTIN-13: 0309047609611 EAN-13: 0309047609611 GTIN-12: 309047609611 UPC-A: 309047609611 GTIN storage (14 digits): 00309047609611 | 09047609-1.jpg |
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 0904-7609-61 | Docusate Sodium | 1 in 1 BLISTER PACK | CAPSULE, LIQUID FILLED | 1 | 3 | |
| 0904-7609-61 | Docusate Sodium | 100 in 1 CARTON | CAPSULE, LIQUID FILLED | 100 | 3 |
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 |
|---|---|
| 0904-7609 | 0904-7609-61 |
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 | Major Pharmaceuticals | 3e8321cf-7eda-d70c-e063-6394a90a35a5 | 2025-12-10 | Warnings | 0904-7609-61 0904-7609 00904760961 8f5fe2d1-2047-45f5-8e9f-a5440b78132b 3e8321cf-7eda-d70c-e063-6394a90a35a5 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.