Dulcolax

Manufacturer
Boehringer Ingelheim Pharmaceuticals, Inc.
Effective date
2018-12-18
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-02 00:40:33

Label at a glance#

ProductDulcolax
Active ingredientBISACODYL
Label structure7 sections

Storage and handling

Other information store at 20-25°C (68-77°F)

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Drug Facts

Active ingredient (in each suppository)Purpose
Bisacodyl (USP) 10 mg .................................... Stimulant laxative

INDICATIONS & USAGE SECTION

Use

OTC - PURPOSE SECTION

  • 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

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 over1 suppository in a single daily dose. Peel open plastic. Insert suppository well into rectum, pointed end first. Retain about 15 to 20 minutes.
children 6 to under 12 years of age1/2 suppository in a single daily dose
children under 6 years of ageask a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at 20-25°C (68-77°F)

INACTIVE INGREDIENT SECTION

Inactive ingredient hard fat

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. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Dulcolax® 10 mg Suppository Carton
NDC: 0597-0052-28

dulcolax-suppositories-carton
dulcolax-suppositories-carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bisacodylACTIVE INGREDIENT10X0709Y6I2
bisacodylACTIVE MOIETY10X0709Y6I2
HYDROGENATED COCONUT OILINACTIVE INGREDIENTJY81OXM1OM2
HYDROGENATED PALM KERNEL OILINACTIVE INGREDIENTFM8D1RE2VP2

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0597-00520597-0052-16, 0597-0052-28, 0597-0052-34, 0597-0052-38, 0597-0052-44

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
FAT, HARD8334LX7S21IACT

Source Document#

Source XML

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.

Inactive ingredient links page 1 of 1 · 1 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
HYDROGENATED COCONUT OILHYDROGENATED COCONUT OILJY81OXM1OMSUPPOSITORY / RECTALNAExact identifier — unii candidate

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.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
fbab0415-cc0c-48cf-b3da-21b5b9be665fb9959929-204f-496e-8cb6-493eee2d57772021-10-29WarningsExact identifier
spl set id: b9959929-204f-496e-8cb6-493eee2d5777

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.