stimulant laxative enteric coated

Manufacturer
Geri-Care Pharmaceutical Corp
Effective date
2024-11-28
Label type
HUMAN OTC DRUG LABEL
Version
9
Source
full-release
Hydrated at
2026-06-01 00:39:47

Label at a glance#

Productstimulant laxative enteric coated
Active ingredientBISACODYL
Label structure9 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 do not take more than directed 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

store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF) 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
  • do not take more than directed
  • 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

  • store at controlled room temperature 20°-25°C (68°-77°F); excursions permitted between 15º-30ºC (59º-86ºF)
  • 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

Package Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN9
308753bisacodyl 5 MG Delayed Release Oral TabletSCD9
308753bisacodyl 5 MG Enteric Coated Oral TabletSY9

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#

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
57896-441-01stimulant laxative enteric coated100 in 1 BOTTLETABLET1009
57896-441-10stimulant laxative enteric coated1000 in 1 BOTTLETABLET10009
57896-441-20stimulant laxative enteric coated200 in 1 BOTTLETABLET2009
57896-441-25stimulant laxative enteric coated1 in 1 CARTONTABLET19
57896-441-25stimulant laxative enteric coated25 in 1 BLISTER PACKTABLET259
57896-441-26stimulant laxative enteric coated25 in 1 BOTTLETABLET259

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
57896-441STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [GERI-CARE PHARMACEUTICAL CORP]9Current NDC, Legacy NDC, 6 package rows20241130_c3fa1050-bb8b-449c-89e6-f5fd508278d2.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

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6I1
BISACODYLACTIVE MOIETY10X0709Y6I1
ACACIAINACTIVE INGREDIENT5C5403N26O1
AMMONIAINACTIVE INGREDIENT5138Q19F1X1
CALCIUM CARBONATEINACTIVE INGREDIENTH0G9379FGK1
CARNAUBA WAXINACTIVE INGREDIENTR12CBM0EIZ1
D&C YELLOW NO. 10INACTIVE INGREDIENT35SW5USQ3G1
DIMETHICONEINACTIVE INGREDIENT92RU3N3Y1O1
FD&C YELLOW NO. 6INACTIVE INGREDIENTH77VEI93A81
FERROSOFERRIC OXIDEINACTIVE INGREDIENTXM0M87F3571
HYPROMELLOSESINACTIVE INGREDIENT3NXW29V3WO1
LACTOSE MONOHYDRATEINACTIVE INGREDIENTEWQ57Q8I5X1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
METHYLPARABENINACTIVE INGREDIENTA2I8C7HI9T1
POLYDEXTROSEINACTIVE INGREDIENTVH2XOU12IE1
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POLYVINYL ACETATE PHTHALATEINACTIVE INGREDIENT58QVG85GW31
POVIDONESINACTIVE INGREDIENTFZ989GH94E1
PROPYLENE GLYCOLINACTIVE INGREDIENT6DC9Q167V31
PROPYLPARABENINACTIVE INGREDIENTZ8IX2SC1OH1
SHELLACINACTIVE INGREDIENT46N107B71O1
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
SODIUM ALGINATEINACTIVE INGREDIENTC269C4G2ZQ1
SODIUM BENZOATEINACTIVE INGREDIENTOJ245FE5EU1
SODIUM BICARBONATEINACTIVE INGREDIENT8MDF5V39QO1
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
STEARIC ACIDINACTIVE INGREDIENT4ELV7Z65AP1
SUCROSEINACTIVE INGREDIENTC151H8M5541
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
TRIACETININACTIVE INGREDIENTXHX3C3X6731
TRIETHYL CITRATEINACTIVE INGREDIENT8Z96QXD6UM1

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
57896-44157896-441-01, 57896-441-10, 57896-441-25, 57896-441-26, 57896-441-20

Ingredients#

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

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

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 4 · 186 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
AMMONIAAMMONIA SOLUTION5138Q19F1XTABLET / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CALCIUM CARBONATECALCIUM CARBONATEH0G9379FGKTABLET / ORAL793 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, EXTENDED RELEASE / ORAL110 mgExact identifier — unii+route
24 equally ranked IID candidates
AMMONIAAMMONIA SOLUTION5138Q19F1XTABLET / ORALNAExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
CARNAUBA WAXCARNAUBA WAXR12CBM0EIZTABLET / ORAL167.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3CAPSULE / ORAL48 mgExact identifier — unii+route
24 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3CAPSULE, EXTENDED RELEASE / ORAL32 mgExact identifier — unii+route
24 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM BICARBONATESODIUM BICARBONATE8MDF5V39QOTABLET / ORAL1300 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, EXTENDED RELEASE / ORAL110 mgExact identifier — unii+route
24 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FERROSOFERRIC OXIDEFERROSOFERRIC OXIDEXM0M87F357TABLET / ORAL2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SUCROSESUCROSEC151H8M554TABLET / ORAL4249 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIETHYL CITRATETRIETHYL CITRATE8Z96QXD6UMTABLET / ORAL52 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3CAPSULE, EXTENDED RELEASE / ORAL32 mgExact identifier — unii+route
24 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYDEXTROSEPOLYDEXTROSEVH2XOU12IETABLET / ORAL20 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQTABLET / ORAL480 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQTABLET / ORAL480 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SODIUM ALGINATESODIUM ALGINATEC269C4G2ZQTABLET / ORAL480 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STEARIC ACIDSTEARIC ACID4ELV7Z65APTABLET / ORAL336 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET / ORAL980 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / ORAL1000 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POVIDONESPOVIDONEFZ989GH94ETABLET / ORAL216 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
FD&C YELLOW NO. 6FD&C YELLOW NO. 6H77VEI93A8TABLET / ORAL60.02 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
TRIACETINTRIACETINXHX3C3X673TABLET / ORAL208 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
ACACIAACACIA5C5403N26OTABLET / ORAL70 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
SHELLACSHELLAC46N107B71OTABLET / ORAL112 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
HYPROMELLOSESHYPROMELLOSE3NXW29V3WOTABLET / ORAL1127 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
METHYLPARABENMETHYLPARABENA2I8C7HI9TTABLET / ORAL1.8 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
PROPYLPARABENPROPYLPARABENZ8IX2SC1OHTABLET / ORAL0.2 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, EXTENDED RELEASE / ORAL110 mgExact identifier — unii+route
24 equally ranked IID candidates
PROPYLENE GLYCOLPROPYLENE GLYCOL6DC9Q167V3TABLET / ORAL64 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3TABLET, DELAYED RELEASE / ORALNAExact identifier — unii+route
24 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3CAPSULE, EXTENDED RELEASE / ORAL32 mgExact identifier — unii+route
24 equally ranked IID candidates
LACTOSE MONOHYDRATELACTOSE MONOHYDRATEEWQ57Q8I5XTABLET / ORAL4384 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
D&C YELLOW NO. 10D&C YELLOW NO. 1035SW5USQ3GTABLET / ORAL80 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET / ORAL1116 mgExact identifier — unii+route+dosage form
6 equally ranked IID candidates
POLYVINYL ACETATE PHTHALATEPOLYVINYL ACETATE PHTHALATE58QVG85GW3CAPSULE / ORAL48 mgExact identifier — unii+route
24 equally ranked IID candidates

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
stimulant laxative enteric coatedBISACODYLGeri-Care Pharmaceutical Corpc3fa1050-bb8b-449c-89e6-f5fd508278d22024-11-28WarningsExact identifier
ndc (package): 57896-441-01
ndc (package): 57896-441-20
ndc (package): 57896-441-25
ndc (package): 57896-441-10
ndc (package): 57896-441-26
ndc (product): 57896-441
ndc11 (package): 57896044126
ndc11 (package): 57896044120
ndc11 (package): 57896044125
ndc11 (package): 57896044110
ndc11 (package): 57896044101
spl id: 27fe61ed-8510-c07b-e063-6394a90a582e
spl set id: c3fa1050-bb8b-449c-89e6-f5fd508278d2

Reported adverse events (FAERS/openFDA)#

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