FDA.reportPublic FDA data

Bisacodyl Laxative

Manufacturer
Neilmed Pharmaceuticals Inc.
Effective date
2025-07-03
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 01:06:33

Label at a glance#

ProductBisacodyl Laxative
Active ingredientBISACODYL
Label structure16 sections

Indications and uses

for relief of occasional constipation this product generally produces bowel movement in 15 to 60 minutes

Dosage and administration

Detach one suppository from the strip Remove suppository from foil as shown in illustration Insert suppository into rectum, pointed end first Adults and children 12 and over 1 suppository once daily Children 6 to under 12 years 1/2 suppository daily Children under 6 years Do not use

Storage and handling

Store at room temperature. Do not exceed 30˚ C (86˚ F) Lot No. & Exp. Date: see wrapper or box

Label contents#

Full prescribing information#

Drug Facts: Active Ingredient

OTC - ACTIVE INGREDIENT SECTION

(in each suppository)
Bisacodyl 10 mg

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation
  • this product generally produces bowel movement in 15 to 60 minutes

Warnings

WARNINGS SECTION

  • For rectal use only

Do not use

OTC - DO NOT USE SECTION

  • when abdominal pain, nausea or vomiting are present
  • for a period longer than 1 week

Ask a doctor before use

OTC - ASK DOCTOR SECTION

if you have noticed a sudden change in bowel habits that lasts over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

it may cause abdominal discomfort, faintness, rectal bleeding and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding
  • you fail to have a bowel movement after using this product. This may indicate a serious condition

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

If swallowed, get medical help or contact a Poison Control Center right away. (1-800-222-1222)

Directions

DOSAGE & ADMINISTRATION SECTION

  • Detach one suppository from the strip
  • Remove suppository from foil as shown in illustration
  • Insert suppository into rectum, pointed end first
Adults and children 12 and over1 suppository once daily
Children 6 to under 12 years1/2 suppository daily
Children under 6 yearsDo not use

Other Information

STORAGE AND HANDLING SECTION

  • Store at room temperature. Do not exceed 30˚ C (86˚ F)
  • Lot No. & Exp. Date: see wrapper or box

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hydrogenated palm kernel oil

Questions?

OTC - QUESTIONS SECTION

Adverse Drug Event Call: 1(877) 477-8633

Important:

SAFE HANDLING WARNING SECTION

Please do not discard this printed box and any enclosed printed material. The inside final product may not have all the details you require for the ongoing use of the product.

Purpose

OTC - PURPOSE SECTION

Purpose - Vasoconstrictor

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl Laxative Suppositories - 10 Aluminium Foil wrapped SuppositoriesBisacodyl Laxative Suppositories - 10 Aluminium Foil wrapped SuppositoriesBisacodyl Laxative Suppositories - 5 Aluminium Foil wrapped SuppositoriesBisacodyl Laxative Suppositories - 5 Aluminium Foil wrapped SuppositoriesBisacodyl Laxative Suppositories - 30 Aluminium Foil wrapped SuppositoriesBisacodyl Laxative Suppositories - 30 Aluminium Foil wrapped Suppositories

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN3
198509bisacodyl 10 MG Rectal SuppositorySCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
13709-328-01Bisacodyl Laxative30 in 1 CARTONSUPPOSITORY303
13709-328-01Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-02Bisacodyl Laxative5 in 1 CARTONSUPPOSITORY53
13709-328-02Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-03Bisacodyl Laxative1.8 g in 1 BLISTER PACKSUPPOSITORY1.83
13709-328-03Bisacodyl Laxative10 in 1 CARTONSUPPOSITORY103

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
13709-32813709-328-01, 13709-328-02, 13709-328-03

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
HYDROGENATED PALM KERNEL OILFM8D1RE2VPIACT

Source Document#

Source XML

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
Bisacodyl LaxativeBISACODYL LAXATIVE SUPPOSITORIESNeilmed Pharmaceuticals Inc.35cb0386-a662-6893-e063-6294a90aa71a2025-07-03WarningsExact identifier
ndc (package): 13709-328-03
ndc (package): 13709-328-01
ndc (package): 13709-328-02
ndc (product): 13709-328
ndc11 (package): 13709032801
ndc11 (package): 13709032803
ndc11 (package): 13709032802
spl id: 3908d3b4-6bfd-dc73-e063-6294a90a5088
spl set id: 35cb0386-a662-6893-e063-6294a90aa71a

Reported adverse events (FAERS/openFDA)#

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