Indications and uses
for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours
for the prevention of dry, hard stools for relief of occasional constipation this product generally produces a bowel movement within 12 to 72 hours
adults and children 12 years of age and over: take 1 softgel daily or as directed by a doctor children under 12 years of age: ask a doctor
each softgel contains: sodium 20 mg Phenylketonurics: Contains phenylalanine 4 mg per softgel store at 15°- 25°C (59°- 77°F)
DOCUSATE SODIUM 250 MG
Stool softener laxative
Do not use if you are presently taking mineral oil, unless directed by a doctor.
Ask a doctor before use if you have
Stop use and ask a doctor if
If pregnant or breast-feeding, ask a health professional before use.
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
FD&C red #40, FD&C yellow #6, gelatin, glycerin, ink (edible), polyethylene glycol, propylene glycol, purified water, sorbitol.
call 1-800-630-8895
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 80513-101 | 80513-101-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| GELATIN TYPE B BOVINE (160 BLOOM) | 1T8387508X | IACT |
| POLYETHYLENE GLYCOL, UNSPECIFIED | 3WJQ0SDW1A | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL SOLUTION | 8KW3E207O2 | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 2 | 2024-09-13 | full-release | 2026-06-01 00:19:41 |
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, EXTRA STRENGTH 250 MG | DOCUSATE SODIUM | Advanced Rx LLC | fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 | 2026-07-06 | Warnings | 80513-101-01 80513-101 80513010101 55fe1154-f793-7cb6-e063-6294a90aad06 fc8cf24e-8ca1-b3fb-e053-6294a90a7a50 |
Adverse event summaries are temporarily unavailable. Other product information remains available.