FDA.reportPublic FDA data

STIMULANT LAXATIVE

Manufacturer
RETAIL BUSINESS SERVICES, LLC
Effective date
2024-12-20
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
full-release
Hydrated at
2026-06-01 00:47:27

Label at a glance#

ProductSTIMULANT LAXATIVE
Active ingredientBISACODYL
Label structure11 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

Active ingredient                 

(In each tablet)

  Bisacodyl 5mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use if you cannot swallow without chewing
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
■ do not chew or crush tablet(s)
■ it may cause stomach discomfort, faintness and
cramps
■ do not use within 1 hour after taking an antacid
or milk

Stop use and ask a doctor if

OTC - STOP USE SECTION


■ 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

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

 In case of overdose, get medical help or contact a Poison Control Center right away 1(800) 222-1222.

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water
  • adults and children 12 years and over: take 1 to 3 tablets in a single daily dose
  • children 6 to under 12 years: take 1 tablet in a single daily dose
  • children under 6 years: ask a doctor

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acadia, Anhydrous Calcium Sulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, FD&C yellow #6 aluminum lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalates, Povidone, Shellac, Sodium Starch Glycolate, Stearic Acid, Sugar, Talc, Titanium Dioxide

Questions or comments?

OTC - QUESTIONS SECTION

1-888-333-9792

DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

GENTLE LAXATIVE

BISACODYL 5 mg


GENTLE YET EFFECTIVE STIMULANT LAXATIVE


25 TABLETS


ENTERIC COATED

CartonCarton

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN5
308753bisacodyl 5 MG Delayed Release Oral TabletSCD5
308753bisacodyl 5 MG Enteric Coated Oral TabletSY5

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

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
72476-845-252024-01-30C16284748780-11030e365-6c00-111a-e063-dadaa90a10e2CARE ONE GENTLE LAXATIVE

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
72476-845-25STIMULANT LAXATIVE25 in 1 BLISTER PACKTABLET, DELAYED RELEASE255
72476-845-25STIMULANT LAXATIVE1 in 1 PACKAGETABLET, DELAYED RELEASE15

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
72476-845STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [RETAIL BUSINESS SERVICES, LLC]5Legacy NDC, 2 package rows20241222_4bb375a0-8ec3-4769-9802-832b8a280e7d.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
72476-84572476-845-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ACACIA5C5403N26OIACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
BISACODYL10X0709Y6IACTIB

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
29bb0975-f9df-8753-e063-6394a90a2be24bb375a0-8ec3-4769-9802-832b8a280e7d2024-12-20WarningsExact identifier
spl id: 29bb0975-f9df-8753-e063-6394a90a2be2
spl set id: 4bb375a0-8ec3-4769-9802-832b8a280e7d

Reported adverse events (FAERS/openFDA)#

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