Indications and uses
relieves occasional constipation (irregularity) generally produces bowel movement in 12 to 72 hours
Docusate Sodium
- Manufacturer
- NuCare Pharmaceuticals,Inc.
- Effective date
- 2024-08-14
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 5
- Source
- full-release
- Hydrated at
- 2026-06-01 00:17:16
Label at a glance#
ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure8 sections
Dosage and administration
• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor • children under 12: consult a doctor • do not exceed recommended dose
Storage and handling
• each softgel contains: sodium 5 mg. very low sodium • store at 15°C-25°C(59° F-77° F) • keep tightly closed • product from USA or Canada • Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Label contents#
Full prescribing information#
Active ingredient (in each softgel)
Docusate Sodium 100 mg
Purpose
Stool Softener Laxative
Uses
- relieves occasional constipation (irregularity)
- generally produces bowel movement in 12 to 72 hours
Warnings
Ask a doctor before use if you
• have stomach pain, nausea or vomiting
• have a sudden change in bowel habits that persists over a period of 2 weeks
• are presently taking mineral oil
Stop use and ask a doctor if
• you need to use a laxative longer than 1 week
• you have rectal bleeding or fail to have a bowel movement. These
could be signs of a serious condition.
If pregnant or breast-feeding, ask a health professional before use.
OTC - KEEP OUT OF REACH OF CHILDREN SECTION
Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center right away.
Directions
• adults and children 12 years and older: take 1-2 softgel daily until first bowel movement; 1 softgel daily thereafter, or as directed by doctor
• children under 12: consult a doctor
• do not exceed recommended dose
Other information
• each softgel contains: sodium 5 mg. very low sodium
• store at 15°C-25°C(59° F-77° F)
• keep tightly closed
• product from USA or Canada
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken.
Inactive ingredients
FD and C red 40, gelatin, glycerin, edible ink, PEG, propylene glycol, sorbitol special, water. May also contain D and C yellow 10, FD and C yellow 6 (sunset yellow), mannitol.
Package Label
DailyMed RxNorm Mappings#
FDA-Initiated Inactive NDC Indexing#
DailyMed Package Descriptions#
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 66267-888-30 | Docusate Sodium | 30 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 30 | 5 | |
| 66267-888-60 | Docusate Sodium | 60 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 60 | 5 | |
| 66267-888-90 | Docusate Sodium | 90 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 90 | 5 | |
| 66267-888-91 | Docusate Sodium | 120 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 120 | 5 | |
| 66267-888-92 | Docusate Sodium | 180 in 1 BOTTLE | CAPSULE, LIQUID FILLED | 180 | 5 |
DailyMed Dashboard NDC Coverage#
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 57896-401-01 | EA - Each | 57896-401 | da8e6844-b6ae-4244-8bfc-f7ad99d8eaf8 | 1 | 2013-06-04 |
| 57896-401-03 | EA - Each | 57896-401 | 6762957d-d7f6-4213-a664-2c7f42fc9f36 | 1 | 2013-06-04 |
| 57896-401-10 | EA - Each | 57896-401 | 7ae1d03c-6162-4398-b8d2-1946db28e941 | 1 | 2013-06-04 |
| 57896-401-20 | EA - Each | 57896-401 | 8f701acd-94d7-43d2-9072-f8fbf72510af | 1 | 2021-02-05 |
| 57896-401-25 | EA - Each | 57896-401 | 5c82cab7-f225-43ff-b3f5-38f5ffd4b01a | 1 | 2018-11-06 |
Products#
Every source-derived product name is available through these pages.
- Docusate Sodium
- GELATIN
- GLYCERIN
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- SORBITOL
- WATER
- D&C YELLOW NO. 10
- FD&C YELLOW NO. 6
- FD&C RED NO. 40
- MANNITOL
- DOCUSATE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 66267-888 | 66267-888-30, 66267-888-60, 66267-888-90, 66267-888-91, 66267-888-92 |
| 57896-401 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| GELATIN | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| SORBITOL | 506T60A25R | IACT |
| WATER | 059QF0KO0R | IACT |
| D&C YELLOW NO. 10 | 35SW5USQ3G | IACT |
| FD&C YELLOW NO. 6 | H77VEI93A8 | IACT |
| FD&C RED NO. 40 | WZB9127XOA | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| DOCUSATE SODIUM | F05Q2T2JA0 | ACTIB |
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 | NuCare Pharmaceuticals,Inc. | 56f7966a-c95e-3ce3-e054-00144ff88e88 | 2024-08-14 | Warnings | 66267-888-60 66267-888-92 66267-888-30 66267-888-90 66267-888-91 66267-888 66267088830 66267088890 66267088891 66267088860 66267088892 1fa79a74-2612-42a5-e063-6394a90a1bbb 56f7966a-c95e-3ce3-e054-00144ff88e88 |
| Stool Softener | DOCUSATE SODIUM | Geri-Care Pharmaceutical Corp | 644d81ec-d38f-4172-a087-727b94e2fefe | 2023-10-19 | Warnings | 57896-401 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.