DulcoEase
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Effective date
- 2017-12-18
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 01:06:01
Label at a glance#
ProductDulcoEase
Active ingredientDOCUSATE SODIUM
Label structure12 sections
Contacts and useful links#
Websitewww.dulcolax.com
www.Dulcolax.com
www.Dulcolax.comLabel contents#
Full prescribing information#
OTC - ACTIVE INGREDIENT SECTION
Drug Facts
| Active ingredient (in each capsule) | Purpose |
| Docusate sodium (USP) 100 mg | Stool softener laxative |
OTC - WHEN USING SECTION
Use
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 12 to 72 hours
OTC - ASK DOCTOR SECTION
Warnings
Ask a doctor before use if you have
- stomach pain, nausea or vomiting
- a sudden change in bowel habits that lasts more than 2 weeks
OTC - ASK DOCTOR/PHARMACIST SECTION
Ask a doctor or pharmacist before use if you are presently taking mineral oil
OTC - STOP USE SECTION
Stop use and ask a doctor if
- you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
- you need to use a laxative for more than 1 week
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.
OTC - PURPOSE SECTION
Directions take with a glass of water
| adults and children 12 years of age and over | 1 to 3 capsules daily. This dose may be taken as a single daily dose or in divided doses. |
| children 2 to under 12 years of age | 1 capsule daily |
| children under 2 years of age | ask a doctor |
DOSAGE FORMS & STRENGTHS SECTION
Other information
- each capsule contains: sodium 6 mg
- store at 20-25°C (68-77°F)
- protect from excessive humidity
- do not use this product if the safety seal under the cap is torn or missing
INACTIVE INGREDIENT SECTION
Inactive ingredients
FD&C Red #40, FD&C Yellow #6, gelatin, glycerin, hypromellose, isopropyl alcohol, mannitol, polyethylene glycol 400, propylene glycol, sorbitan, sorbitol, titanium dioxide, water
OTC - QUESTIONS SECTION
Questions? Call 1-888-285-9159 (English/Spanish) M – F,
8:30 – 5 EST, or visit www.Dulcolax.com
Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. © 2016, BI Pharmaceuticals, Inc. All rights reserved.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DulcoEase®
25 Capsules
NDC: 0597-0330-28
Products#
Every source-derived product name is available through these pages.
- DulcoEase
- Docusate sodium
- DOCUSATE
- FD&C RED NO. 40
- FD&C YELLOW NO. 6
- GELATIN
- GLYCERIN
- HYPROMELLOSES
- ISOPROPYL ALCOHOL
- POLYETHYLENE GLYCOL 400
- PROPYLENE GLYCOL
- WATER
- SORBITOL
- MANNITOL
- SORBITAN
- TITANIUM DIOXIDE
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0597-0330 | 0597-0330-28, 0597-0330-83, 0597-0330-01, 0597-0330-89, 0597-0330-57 |
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 | 2G86QN327L | IACT |
| GLYCERIN | PDC6A3C0OX | IACT |
| HYPROMELLOSES | 3NXW29V3WO | IACT |
| ISOPROPYL ALCOHOL | ND2M416302 | IACT |
| POLYETHYLENE GLYCOL 400 | B697894SGQ | IACT |
| PROPYLENE GLYCOL | 6DC9Q167V3 | IACT |
| WATER | 059QF0KO0R | IACT |
| SORBITOL | 506T60A25R | IACT |
| MANNITOL | 3OWL53L36A | IACT |
| SORBITAN | 6O92ICV9RU | IACT |
| TITANIUM DIOXIDE | 15FIX9V2JP | 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 |
|---|---|---|---|---|---|---|
| cec8c155-b504-4f70-8247-fb0b61dd5161 | b1782087-d411-5cc9-3fe9-7e88c4b7eff8 | 2021-11-01 | b1782087-d411-5cc9-3fe9-7e88c4b7eff8 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.