FDA.reportPublic FDA data

Bisacodyl

Manufacturer
Bryant Ranch Prepack
Effective date
2025-03-31
Label type
HUMAN OTC DRUG LABEL
Version
104
Source
full-release
Hydrated at
2026-06-01 00:58:18

Label at a glance#

ProductBisacodyl
Active ingredientBISACODYL
Label structure10 sections

Indications and uses

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

Dosage and administration

do not take more than directed 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

Storage and handling

TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity see end flap for expiration date and lot number

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 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

  • stomach 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
  • it may cause stomach discomfort, faintness, and cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • do not take more than directed
  • take with a glass of water
adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 yearstake 1 tablet in a single daily dose
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • TAMPER EVIDENT: DO NOT USE IF OUTER PACKAGE IS OPENED OR BLISTER IS TORN OR BROKEN
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see end flap for expiration date and lot number

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #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 or comments?

OTC - QUESTIONS SECTION

1-800-426-9391

HOW SUPPLIED

How Supplied Section

Bisacodyl USP, 5 mg

NDC: 71335-2010-0: 25 Tablets in a BOTTLE

NDC: 71335-2010-1: 30 Tablets in a BOTTLE

NDC: 71335-2010-2: 2 Tablets in a BOTTLE

NDC: 71335-2010-3: 3 Tablets in a BOTTLE

NDC: 71335-2010-4: 4 Tablets in a BOTTLE

NDC: 71335-2010-5: 10 Tablets in a BOTTLE

NDC: 71335-2010-6: 90 Tablets in a BOTTLE

NDC: 71335-2010-7: 8 Tablets in a BOTTLE

NDC: 71335-2010-8: 100 Tablets in a BOTTLE

NDC: 71335-2010-9: 20 Tablets in a BOTTLE

Repackaged/Relabeled by:
Bryant Ranch Prepack, Inc.
Burbank, CA 91504

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl 5mg Tablet

Label
Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN104
308753bisacodyl 5 MG Delayed Release Oral TabletSCD104
308753bisacodyl 5 MG Enteric Coated Oral TabletSY104

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
71335-2010-0Bisacodyl25 in 1 BOTTLETABLET, DELAYED RELEASE25104
71335-2010-1Bisacodyl30 in 1 BOTTLETABLET, DELAYED RELEASE30104
71335-2010-2Bisacodyl2 in 1 BOTTLETABLET, DELAYED RELEASE2104
71335-2010-3Bisacodyl3 in 1 BOTTLETABLET, DELAYED RELEASE3104
71335-2010-4Bisacodyl4 in 1 BOTTLETABLET, DELAYED RELEASE4104
71335-2010-5Bisacodyl10 in 1 BOTTLETABLET, DELAYED RELEASE10104
71335-2010-6Bisacodyl90 in 1 BOTTLETABLET, DELAYED RELEASE90104
71335-2010-7Bisacodyl8 in 1 BOTTLETABLET, DELAYED RELEASE8104
71335-2010-8Bisacodyl100 in 1 BOTTLETABLET, DELAYED RELEASE100104
71335-2010-9Bisacodyl20 in 1 BOTTLETABLET, DELAYED RELEASE20104

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-2010BISACODYL TABLET, DELAYED RELEASE [BRYANT RANCH PREPACK]104Current NDC, Legacy NDC, 10 package rows20250402_71dea737-3fde-461f-958d-3a39ebdbf1ae.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71335-2010-4EA - Each71335-2010709a79ed-f4d2-4e5c-ae3e-0fcf2a20a8b012025-08-11
0904-6748-17EA - Each0904-67484ad50450-99a7-40b2-99ea-4f1812c5b8c712019-02-13
0904-6748-60EA - Each0904-67485fe1e51f-a913-40d6-87f6-860c57fcac9612018-12-13
0904-6748-80EA - Each0904-674880e9234e-96db-4f38-8270-ce64e0dce73612018-12-13

Products#

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

DailyMed product names page 1 of 1 · 33 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
71335-201071335-2010-0, 71335-2010-1, 71335-2010-2, 71335-2010-3, 71335-2010-4, 71335-2010-5, 71335-2010-6, 71335-2010-7, 71335-2010-8, 71335-2010-9
0904-6748

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

Name, UNII, Kind table
NameUNIIKind
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OIACT
WATER059QF0KO0RIACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT

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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
BisacodylBISACODYLMajor Pharmaceuticals6b85af55-35db-4630-8bc0-9ff4fbf5990a2025-11-19WarningsExact identifier
ndc (product): 0904-6748
BisacodylBISACODYLBryant Ranch Prepack71dea737-3fde-461f-958d-3a39ebdbf1ae2025-03-31WarningsExact identifier
ndc (package): 71335-2010-9
ndc (package): 71335-2010-2
ndc (package): 71335-2010-0
ndc (package): 71335-2010-6
ndc (package): 71335-2010-7
ndc (package): 71335-2010-4
ndc (package): 71335-2010-5
ndc (package): 71335-2010-3
ndc (package): 71335-2010-1
ndc (package): 71335-2010-8
ndc (product): 71335-2010
ndc11 (package): 71335201004
ndc11 (package): 71335201005
ndc11 (package): 71335201003
ndc11 (package): 71335201006
ndc11 (package): 71335201009
ndc11 (package): 71335201000
ndc11 (package): 71335201007
ndc11 (package): 71335201002
ndc11 (package): 71335201008
ndc11 (package): 71335201001
spl id: 42ebd7ff-4d1b-4c81-9374-43cbef0dad3a
spl set id: 71dea737-3fde-461f-958d-3a39ebdbf1ae

Reported adverse events (FAERS/openFDA)#

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