FDA.reportPublic FDA data

Fleet

Manufacturer
C.B. Fleet Company, Inc.
Effective date
2024-06-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-06-01 00:14:13

Label at a glance#

ProductFleet
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

for temporary relief of occasional constipation and irregularity this product generally produces bowel movement in 6 to 12 hours

Dosage and administration

Take with a glass of water Adults and children 12 years of age and over 1 to 3 tablets in a single daily dose Children 6 to under 12 years of age 1 tablet in a single daily dose Children under 6 years of age ask a doctor

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 5 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Uses

INDICATIONS & USAGE SECTION

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

WARNINGS SECTION

Do not use

OTC - DO NOT USE SECTION

if you cannot swallow without chewing

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When using this product

OTC - WHEN USING SECTION

  • do not chew or crush tablet(s)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness and cramps

Stop use and ask a doctor if  

OTC - STOP USE SECTION

  • you have rectal bleeding or no bowel movement after use of a laxative 

These symptoms may indicate 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • Take with a glass of water
Adults and children 12 years of age and over1 to 3 tablets in a single daily dose
Children 6 to under 12 years of age1 tablet in a single daily dose
Children under 6 years of ageask a doctor

Other information

OTHER SAFETY INFORMATION

  • store between 68º to 77ºF (20º to 25ºC)

Tamper Evident: Do not use if blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow no. 10 aluminum lake, FD&C yellow no. 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

OTC - QUESTIONS SECTION

Call 1-866-255-6960

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fleet

Bisacodyl 5 mg Stimulant

stimulant

oral laxative

25 coated tablets

Principal Display Panel Fleet Bisacodyl 5 mg Stimulant stimulant oral laxative 25 coated tabletsPrincipal Display Panel Fleet Bisacodyl 5 mg Stimulant stimulant oral laxative 25 coated tablets

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN1
308753bisacodyl 5 MG Delayed Release Oral TabletSCD1
308753bisacodyl 5 MG Enteric Coated Oral TabletSY1

DailyMed Pharmacologic Classes#

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

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb7ab793-2c12-4079-b100-a64f73bef25aProduct name420240712
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name520200925
816b97af-edc5-4060-aff1-b814bdbcad50Product name120190415
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
419aab54-5d5a-4146-9453-026d4a9991beProduct name220170525
08ffbcbf-26df-b99c-1dab-64fc4cfae89fProduct name220160823
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
0132-0401-25Fleet25 in 1 BLISTER PACKTABLET, COATED251

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
0132-0401FLEET (BISACODYL) TABLET, COATED [C.B. FLEET COMPANY, INC.]1Current NDC, 1 package rows20240627_4e0d973f-e6dc-48d9-8df3-1d47c87840f1.zip

Products#

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

DailyMed product names page 1 of 1 · 32 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0132-04010132-0401-25

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 30 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
Polyvinyl Acetate Phthalate58QVG85GW3IACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
DIMETHICONE92RU3N3Y1OIACT

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
FleetBISACODYLC.B. Fleet Company, Inc.4e0d973f-e6dc-48d9-8df3-1d47c87840f12024-06-21WarningsExact identifier
ndc (package): 0132-0401-25
ndc (product): 0132-0401
ndc11 (package): 00132040125
spl id: 4340697d-d634-493f-8b79-cdf7a1b30fff
spl set id: 4e0d973f-e6dc-48d9-8df3-1d47c87840f1

Reported adverse events (FAERS/openFDA)#

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