FDA.reportPublic FDA data

stimulant laxative enteric coated

Manufacturer
Aphena Pharma Solutions - Tennessee, LLC
Effective date
2025-01-09
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:51:43

Label at a glance#

Productstimulant laxative enteric coated
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

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

Dosage and administration

• do not take more than directed • swallow whole, do not chew or crush • take recommended dose in a single daily dose • take with water • adults and children 12 years and older: take 1-3 (usually 2) tablets daily • children 12 and under: ask a doctor

Storage and handling

• store at room temperature • avoid excessive humidity • Tamper Evident: Do not use if imprinted seal under cap is missing or broken • package not child resistant • for institutional use only

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

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

Warnings

WARNINGS SECTION

Do not use

• for more than one week unless directed by a doctor

• if you cannot swallow without chewing

• within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

• abdominal pain

• nausea

• vomiting

• a sudden change in bowel habits that lasts longer than 2 weeks

When using this product• abdominal discomfort, faintness, or cramps may occur

Stop use and ask a doctor

• if you have no bowel movement within 12 hours

• if you have rectal bleeding

• these could be signs of a serious condition

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

• do not take more than directed
• swallow whole, do not chew or crush
• take recommended dose in a single daily dose
• take with water
• adults and children 12 years and older: take 1-3 (usually 2) tablets daily
• children 12 and under: ask a doctor

Other information

STORAGE AND HANDLING SECTION

• store at room temperature
• avoid excessive humidity
• Tamper Evident: Do not use if imprinted seal under cap is missing or broken
• package not child resistant
• for institutional use only

Inactive ingredients

INACTIVE INGREDIENT SECTION

Acacia, Ammonium Hydroxide, Calcium Carbonate, Corn Starch, D and C Yellow NO. 10 Lake, FD and C Yellow NO. 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. May also contain: Calcium Sulfate, Gelatin, Sodium Starch Glycolate.

Repackaging Information

SPL UNCLASSIFIED SECTION

Please reference the How Suppliedsection listed above for a description of individual tablets. This drug product has been received by Aphena Pharma - TN in a manufacturer or distributor packaged configuration and repackaged in full compliance with all applicable cGMP regulations. The package configurations available from Aphena are listed below:

Count5 mg
271610-453-02
471610-453-04
2071610-453-20

Store between 20°-25°C (68°-77°F). See USP Controlled Room Temperature. Dispense in a tight light-resistant container as defined by USP. Keep this and all drugs out of the reach of children.

Repackaged by:
Aphena Pharma Solutions - TNAphena Pharma Solutions - TN
Cookeville, TN 38506

20200805JH

PRINCIPAL DISPLAY PANEL - 5 mg

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 71610-453 - Bisacodyl 5 mg Tablets
Bottle Label 5 mgBottle Label 5 mg

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
308753bisacodyl 5 MG Delayed Release Oral TabletPSN4
308753bisacodyl 5 MG Delayed Release Oral TabletSCD4
308753bisacodyl 5 MG Enteric Coated Oral TabletSY4

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
71610-453-02stimulant laxative enteric coated2 in 1 BOTTLETABLET24
71610-453-04stimulant laxative enteric coated4 in 1 BOTTLETABLET44
71610-453-20stimulant laxative enteric coated20 in 1 BOTTLETABLET204

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
71610-453STIMULANT LAXATIVE ENTERIC COATED (BISACODYL) TABLET [APHENA PHARMA SOLUTIONS - TENNESSEE, LLC]4Current NDC, Legacy NDC, 3 package rows20250112_0331c762-d318-48d6-97ed-86499c6c8b30.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
71610-453-20EA - Each71610-4538e114329-7737-412c-92aa-432d3135030212021-11-09
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
71610-45371610-453-02, 71610-453-04, 71610-453-20
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
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
LACTOSE MONOHYDRATEEWQ57Q8I5XIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
PROPYLPARABENZ8IX2SC1OHIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
DIMETHICONE92RU3N3Y1OIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
SODIUM ALGINATEC269C4G2ZQIACT
SODIUM BENZOATEOJ245FE5EUIACT
SODIUM BICARBONATE8MDF5V39QOIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
TRIACETINXHX3C3X673IACT
TRIETHYL CITRATE8Z96QXD6UMIACT
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 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
stimulant laxative enteric coatedBISACODYLAphena Pharma Solutions - Tennessee, LLC0331c762-d318-48d6-97ed-86499c6c8b302025-01-09WarningsExact identifier
ndc (package): 71610-453-04
ndc (package): 71610-453-02
ndc (package): 71610-453-20
ndc (product): 71610-453
ndc11 (package): 71610045302
ndc11 (package): 71610045320
ndc11 (package): 71610045304
spl id: 2b4c7710-ccef-da92-e063-6394a90a5416
spl set id: 0331c762-d318-48d6-97ed-86499c6c8b30
stimulant laxative enteric coatedBISACODYLGeri-Care Pharmaceutical Corpc3fa1050-bb8b-449c-89e6-f5fd508278d22024-11-28WarningsExact identifier
ndc (product): 57896-441

Reported adverse events (FAERS/openFDA)#

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