Gentle Laxative Bisacodyl

Manufacturer
NeilMed Pharmaceuticals Inc | NeilMed Pharmaceuticals Inc.
Effective date
2025-01-17
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-06-01 00:52:56

Label at a glance#

ProductGentle Laxative Bisacodyl
Active ingredientBISACODYL
Label structure17 sections

Indications and uses

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

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

Drug facts

OTC - PURPOSE SECTION

Purpose
Bisacodyl 10 mg ................................. Stimulant Laxative

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.

DOSAGE & ADMINISTRATION SECTION

Directions

■ detach one suppository from the strip
■ remove wrapper before inserting into the rectum


adults and children 12 and over : 1 suppository once daily
children 6 to under 12 years : ½ suppository once daily
children under 6 years : do 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 ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Questions?

OTC - QUESTIONS SECTION

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

Tamper evident seal:

SAFE HANDLING WARNING SECTION

Do not use if wrapper on an individual suppository is broken or missing.

INTENDED USE OF THE DEVICE

Prompt, predictable relief from constipation

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Gentle Laxative BisacodylGentle Laxative Bisacodyl

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN2
198509bisacodyl 10 MG Rectal SuppositorySCD2

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
13709-321-01Gentle Laxative Bisacodyl6 in 1 BLISTER PACKSUPPOSITORY62
13709-321-01Gentle Laxative Bisacodyl5 in 1 CARTONSUPPOSITORY52

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
13709-321GENTLE LAXATIVE BISACODYL SUPPOSITORY [NEILMED PHARMACEUTICALS INC]2Current NDC, 2 package rows20250119_03b3733a-4d78-149f-e063-6294a90a6518.zip

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
13709-32113709-321-01

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
PALM KERNEL OILB0S90M0233IACT

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
Gentle Laxative BisacodylGENTLE LAXATIVE BISACODYLNeilMed Pharmaceuticals Inc03b3733a-4d78-149f-e063-6294a90a65182025-01-17WarningsExact identifier
ndc (package): 13709-321-01
ndc (product): 13709-321
ndc11 (package): 13709032101
spl id: 2beb19bf-3d35-ed44-e063-6294a90a7eef
spl set id: 03b3733a-4d78-149f-e063-6294a90a6518

Reported adverse events (FAERS/openFDA)#

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