Indications and uses
For the relief of occasional constipation. Helps to prevent dry, hard stools. This product generally produces a bowel movement within 12 to 72 hours.
Docusate Sodium capsule
- Manufacturer
- Precision Dose, Inc.
- Effective date
- 2024-01-12
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 2
- Source
- legacy-cache
- Hydrated at
- 2026-08-01 21:12:20
Label at a glance#
ProductDocusate Sodium
Active ingredientDOCUSATE SODIUM
Label structure13 sections
Dosage and administration
Adult and Children over 12 years of age Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. Children under 12 years of age Do not use this product for children under 12 years of age, unless directed by a doctor.
Storage and handling
Each softgel contains 13 mg of Sodium. Store at room temperature between 15°C to 25°C (59°F to 77°F).
Contacts and useful links#
Label contents#
Full prescribing information#
SPL UNCLASSIFIED SECTION
Drug Facts
Active ingredient (in each softgel)
Docusate Sodium 250 mg
Purpose
Stool Softener
Uses
- For the relief of occasional constipation.
- Helps to prevent dry, hard stools.
- This product generally produces a bowel movement within 12 to 72 hours.
WARNINGS
Do not use
- If you are currently taking mineral oil, unless directed by a doctor.
- When abdominal pain, nausea or vomiting are present.
- For longer than one week unless directed by a doctor.
OTC - ASK DOCTOR SECTION
Ask a doctor before use if you noticed a sudden change in bowel habits that persists over a period of two weeks.
Stop use and ask a doctor if
- You have rectal bleeding.
- You fail to have a bowel movement after use.
OTC - PREGNANCY OR BREAST FEEDING SECTION
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
| Adult and Children over 12 years of age | Take orally 1 softgel preferably at bedtime for 2-3 days or until bowel movements are normal, or as directed by a doctor. |
| Children under 12 years of age | Do not use this product for children under 12 years of age, unless directed by a doctor. |
Other information
- Each softgel contains 13 mg of Sodium.
- Store at room temperature between 15°C to 25°C (59°F to 77°F).
Inactive ingredients
FD&C Red #40, FD&C Yellow #6, Gelatin, Glycerin, Ink (Edible), Polyethylene Glycol, Propylene Glycol, Purified Water, Sorbitol.
How Supplied
NDC 68094-052-61
Unit Dose Packages of 100 Softgels (10×10) per Carton
SPL UNCLASSIFIED SECTION
Distributed by:
National Vitamin Company
Casa Grande, AZ 85122
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
OTC - QUESTIONS SECTION
For inquiries call Precision Dose, Inc. at 1-800-397-9228 or email druginfo@precisiondose.com
SPL UNCLASSIFIED SECTION
LI1459 Rev. 06/21
PRINCIPAL DISPLAY PANEL - 250 mg Softgel Blister Pack Carton
Precision Dose™
NDC 68094-052-61
Unit Dose
Docusate Sodium, USP
250 mg Softgels
100 Softgels
(10 x 10)
(in each softgel)
Docusate Sodium 250 mg Stool Softener
Each softgel contains 13 mg of Sodium.
USUAL DOSE: SEE ENCLOSED INSERT.
Store at room temperature between
15°C to 25°C (59°F to 77°F).
Keep out of reach of children.
Hospital Use Only.
LC1458
R0
Packaged by:
Precision Dose, Inc.
South Beloit, IL 61080
DailyMed Billing Units#
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 68094-052-59 | EA - Each | 68094-052 | 1734985c-665b-47db-b86c-4a2866b281a8 | 1 | 2022-11-07 |
| 68094-052-61 | EA - Each | 68094-052 | 127049c0-fcd4-409e-9213-e43d94322783 | 1 | 2022-11-07 |
| 54629-601-01 | EA - Each | 54629-601 | e245c595-3a46-46e1-9d19-668930bf45bd | 1 | 2013-02-13 |
| 54629-601-99 | EA - Each | 54629-601 | 097fce90-d965-4325-ad79-a72f0644601b | 1 | 2013-02-13 |
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 1000
- PROPYLENE GLYCOL
- WATER
- SORBITOL
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 68094-052 | 68094-052-59, 68094-052-61 |
| 54629-601 |
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 1000 | U076Q6Q621 | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | 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 | National Vitamin Company | 0c66642c-82cb-42cd-82bb-5f95852cc5d1 | 2024-12-12 | Warnings | 54629-601 |
| ea85388c-b67d-4934-9c5a-c8453597b3b5 | f8da3187-55d4-4e6f-a8ed-a0f76744e7ee | 2024-01-12 | Warnings | ea85388c-b67d-4934-9c5a-c8453597b3b5 f8da3187-55d4-4e6f-a8ed-a0f76744e7ee |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.