Dulcolax
- Manufacturer
- Boehringer Ingelheim Pharmaceuticals, Inc.
- Effective date
- 2018-12-19
- Label type
- HUMAN OTC DRUG LABEL
- Version
- 3
- Source
- legacy-cache
- Hydrated at
- 2026-08-02 00:40:28
Label at a glance#
Contacts and useful links#
Label contents#
Full prescribing information#
DESCRIPTION SECTION
Drug Facts
OTC - ACTIVE INGREDIENT SECTION
| Active ingredient (in each suppository) | Purpose |
| Bisacodyl (USP) 10 mg | Stimulant laxative |
OTC - PURPOSE SECTION
INDICATIONS & USAGE SECTION
Use
- for temporary relief of occasional constipation and irregularity
- this product generally produces bowel movement in 15 minutes to 1 hour
WARNINGS SECTION
Warnings
For rectal use only
OTC - ASK DOCTOR SECTION
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 - WHEN USING SECTION
When using this product it may cause stomach discomfort, faintness, rectal burning and mild cramps
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. If swallowed, get medical help or contact a Poison Control Center right away.
DOSAGE & ADMINISTRATION SECTION
Directions
| adults and children 12 years of age and over | 1 suppository in a single daily dose. See consumer leaflet for proper, safe use of the applicator. |
| children 6 to under 12 years of age | Ask a doctor. Applicator not for use in children under 12 years of age. |
| children under 6 years of age |
SPL UNCLASSIFIED SECTION
Other information
- store at 20°-25°C (68°-77°F)
INACTIVE INGREDIENT SECTION
Inactive ingredient hard fat
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. Product of Italy. Manufactured in Italy. © 2015, Boehringer Ingelheim Pharmaceuticals, Inc. All rights reserved.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
DailyMed Socrata Ingredients#
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| bisacodyl | ACTIVE INGREDIENT | 10X0709Y6I | 1 | |
| bisacodyl | ACTIVE MOIETY | 10X0709Y6I | 1 | |
| FAT, HARD | INACTIVE INGREDIENT | 8334LX7S21 | 1 |
Products#
Every source-derived product name is available through these pages.
- Dulcolax
- Bisacodyl
- DEACETYLBISACODYL
- FAT, HARD
NDC Codes#
| Product NDC | Package NDC |
|---|---|
| 0597-0162 | 0597-0162-03 |
Ingredients#
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| BISACODYL | 10X0709Y6I | ACTIB |
| FAT, HARD | 8334LX7S21 | IACT |
Source Document#
Inactive ingredient matches#
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| FAT, HARD | HARD FAT | 8334LX7S21 | CAPSULE / ORAL | 153 mg | ||
| FAT, HARD | HARD FAT | 8334LX7S21 | SUPPOSITORY / RECTAL | 7657 mg |
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 |
|---|---|---|---|---|---|---|
| b0528a9d-1356-4d07-8331-4750c0ef1f23 | 8459ee71-64eb-daba-d73d-b6ee37b945d1 | 2021-10-29 | Warnings | 8459ee71-64eb-daba-d73d-b6ee37b945d1 |
Reported adverse events (FAERS/openFDA)#
Adverse event summaries are temporarily unavailable. Other product information remains available.
