FDA.reportPublic FDA data

stimulant laxative enteric coated

Manufacturer
Bryant Ranch Prepack
Effective date
2024-01-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-06-01 00:07:36

Label at a glance#

Productstimulant laxative enteric coated
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

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

Storage and handling

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken • store at room temperature 15°-30°C (59°-86°F) • avoid excessive humidity • package not child resistant

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl 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 if you cannot swallow without chewing
Ask a doctor before use if you have
• stomach pain, nausea, vomiting
• noticed a sudden change in bowel habits that lasts more than 2 weeks
When using this product • 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 • 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, ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 and older: take 1 to 3 tablets in a single daily dose
  • children 12 and under: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• store at room temperature 15°-30°C (59°-86°F)
• avoid excessive humidity • package not child resistant

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide,
calcium carbonate, corn starch, D&C yellow #10 lake,
FD&C yellow #6 lake, hypromellose, iron oxide black, lactose,
magnesium stearate, methylparaben, PEG, polydextrose,
polyvinyl acetate phthalate, propylparaben, propylene glycol,
povidone, shellac, simethicone, silica, sodium alginate,
sodium benzoate, sodium bicarbonate, stearic acid, sucrose,
talc, titanium dioxide, triacetin, triethyl citrate, wax.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-540-3765

HOW SUPPLIED

How Supplied Section

NDC: 71335-1531-0: 25 Tablets in a BOTTLE

NDC: 71335-1531-1: 30 Tablets in a BOTTLE

NDC: 71335-1531-2: 2 Tablets in a BOTTLE

NDC: 71335-1531-3: 3 Tablets in a BOTTLE

NDC: 71335-1531-4: 4 Tablets in a BOTTLE

NDC: 71335-1531-5: 10 Tablets in a BOTTLE

NDC: 71335-1531-6: 90 Tablets in a BOTTLE

NDC: 71335-1531-7: 8 Tablets in a BOTTLE

NDC: 71335-1531-8: 100 Tablets in a BOTTLE

NDC: 71335-1531-9: 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 TabletPSN3
308753bisacodyl 5 MG Delayed Release Oral TabletSCD3
308753bisacodyl 5 MG Enteric Coated Oral TabletSY3

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
594e2c86-3079-4e6e-96c9-48f7a8afc78dProduct name120230718
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
c6f86816-7da6-43ea-8c25-ac9758311cc5Product name120220118
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
252e11b6-1a9a-4283-a242-df2c129c496dProduct name320170717
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
71335-1531-0stimulant laxative enteric coated25 in 1 BOTTLETABLET253
71335-1531-1stimulant laxative enteric coated30 in 1 BOTTLETABLET303
71335-1531-2stimulant laxative enteric coated2 in 1 BOTTLETABLET23
71335-1531-3stimulant laxative enteric coated3 in 1 BOTTLETABLET33
71335-1531-4stimulant laxative enteric coated4 in 1 BOTTLETABLET43
71335-1531-5stimulant laxative enteric coated10 in 1 BOTTLETABLET103
71335-1531-6stimulant laxative enteric coated90 in 1 BOTTLETABLET903
71335-1531-7stimulant laxative enteric coated8 in 1 BOTTLETABLET83
71335-1531-8stimulant laxative enteric coated100 in 1 BOTTLETABLET1003
71335-1531-9stimulant laxative enteric coated20 in 1 BOTTLETABLET203

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71335-1531STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [BRYANT RANCH PREPACK]3Current NDC, Legacy NDC, 10 package rows20240120_06940a9d-02bb-4b8e-b1cf-d69d94a30b67.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-441-01EA - Each57896-441e7ebc5d2-1ce7-40e7-bf38-32cc9686493512014-07-02
57896-441-10EA - Each57896-441cda9764f-626f-4803-b355-616daef112c912018-01-12
57896-441-20EA - Each57896-441eb20457a-3154-4cfd-93c7-c4b3f8ff684e12022-03-09
57896-441-25EA - Each57896-44103c2adbe-8c24-470a-b5d5-c3ac0904395212018-01-12
57896-441-26EA - Each57896-44132af55fc-6077-46f2-853e-fbf166be9eb712018-11-06

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
71335-153171335-1531-0, 71335-1531-1, 71335-1531-2, 71335-1531-3, 71335-1531-4, 71335-1531-5, 71335-1531-6, 71335-1531-7, 71335-1531-8, 71335-1531-9
57896-441

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 31 matching rows.

Name, UNII, Kind table
NameUNIIKind
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSE, UNSPECIFIED3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONE, UNSPECIFIEDFZ989GH94EIACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT

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
stimulant laxative enteric coatedBISACODYLGeri-Care Pharmaceutical Corpc3fa1050-bb8b-449c-89e6-f5fd508278d22024-11-28WarningsExact identifier
ndc (product): 57896-441
stimulant laxative enteric coatedBISACODYLBryant Ranch Prepack06940a9d-02bb-4b8e-b1cf-d69d94a30b672024-01-19WarningsExact identifier
ndc (package): 71335-1531-7
ndc (package): 71335-1531-0
ndc (package): 71335-1531-5
ndc (package): 71335-1531-3
ndc (package): 71335-1531-2
ndc (package): 71335-1531-9
ndc (package): 71335-1531-4
ndc (package): 71335-1531-8
ndc (package): 71335-1531-1
ndc (package): 71335-1531-6
ndc (product): 71335-1531
ndc11 (package): 71335153107
ndc11 (package): 71335153103
ndc11 (package): 71335153100
ndc11 (package): 71335153106
ndc11 (package): 71335153109
ndc11 (package): 71335153104
ndc11 (package): 71335153105
ndc11 (package): 71335153108
ndc11 (package): 71335153101
ndc11 (package): 71335153102
spl id: 28debe6e-1735-4f92-a4f2-96d6b3e690bf
spl set id: 06940a9d-02bb-4b8e-b1cf-d69d94a30b67

Reported adverse events (FAERS/openFDA)#

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