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#

ProductDulcolax
Active ingredientBISACODYL
Label structure2 sections

Label contents#

Full prescribing information#

DESCRIPTION SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)Purpose
Bisacodyl (USP) 10 mgStimulant 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 over1 suppository in a single daily dose. See consumer leaflet for proper, safe use of the applicator.
children 6 to under 12 years of ageAsk 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

Carton - Dulcolax Suppositories with DulcoGlide Applicators

dulcoease-suppository-carton
dulcoease-suppository-carton

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
bisacodylACTIVE INGREDIENT10X0709Y6I1
bisacodylACTIVE MOIETY10X0709Y6I1
FAT, HARDINACTIVE INGREDIENT8334LX7S211

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
0597-01620597-0162-03

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 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FAT, HARDHARD FAT8334LX7S21CAPSULE / ORAL153 mgExact identifier — unii candidate
2 equally ranked IID candidates
FAT, HARDHARD FAT8334LX7S21SUPPOSITORY / RECTAL7657 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
b0528a9d-1356-4d07-8331-4750c0ef1f238459ee71-64eb-daba-d73d-b6ee37b945d12021-10-29WarningsExact identifier
spl set id: 8459ee71-64eb-daba-d73d-b6ee37b945d1

Reported adverse events (FAERS/openFDA)#

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