FDA.reportPublic FDA data

STIMULANT LAXATIVE

Manufacturer
CARDINAL HEALTH | TIME CAP LABORATORIES, INC | TIME CAP LABORATORIES, INC.
Effective date
2024-01-10
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:14:58

Label at a glance#

ProductSTIMULANT LAXATIVE
Active ingredientBISACODYL
Label structure8 sections

Label contents#

Full prescribing information#

OTC - ACTIVE INGREDIENT SECTION

In each tablet: Bisacodyl 5mg

INACTIVE INGREDIENT SECTION

Acacia, Anhydrous CalciumSulfate, Anhydrous Lactose, Carnauba Wax, Colloidal Silicon Dioxide, Corn Starch, D&C Yellow #10 Aluminum Lake, Gelatin, Iron Oxide, Iron Oxide Black, Iron Oxide Yellow(Iron Oxide Ochre), Magnesium Stearate, Microcrystalline Cellulose, Polyethylene Glycol (PEG) 400, Polyvinyl Acetate Phthalatic, Povidone, Shellac, Sodium Starch Glycolate,Stearic Acid, Sugar, Talc, Titanium Dioxide

OTC - PURPOSE SECTION

Stimulant Laxative

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.

INDICATIONS & USAGE SECTION

Temporarily reliefves occasional constipation and irregularity

WARNINGS SECTION

Warning:  Do not use if you cannot swallow without chewing.

Ask a doctor before use if you have:  stomach pain, nausea or vomiting; A sudden change in bowel habits that lasts more than two weeks.

When using this product:  Do not chew or crush tablet(s); Do not use within 1 hour after taking an antacid or milk; Do not use this product if you have stomack discomfort, faintness or cramps.

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years and over: take 1 to 3 tablets (usually 2A) daily, or as directed by a doctor
children 6 to under 12 years: take 1 tablet daily, or as directed by a doctor
children under 6 yearts: ask a doctor

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image descriptionimage description

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70000-0228STIMULANT LAXATIVE (BISACODYL) TABLET, DELAYED RELEASE [CARDINAL HEALTH]4Legacy NDC20240112_cbee5fd2-4533-4361-ab8f-eb4d52a35e62.zip

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
70000-022870000-0228-1

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

Name, UNII, Kind table
NameUNIIKind
ACACIA5C5403N26OIACT
CALCIUM SULFATE ANHYDROUSE934B3V59HIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 1035SW5USQ3GIACT
FD&C YELLOW NO. 6H77VEI93A8IACT
GELATIN2G86QN327LIACT
FERROSOFERRIC OXIDEXM0M87F357IACT
FERRIC OXIDE YELLOWEX438O2MRTIACT
MAGNESIUM STEARATE70097M6I30IACT
CELLULOSE, MICROCRYSTALLINEOP1R32D61UIACT
POLYETHYLENE GLYCOL 400B697894SGQIACT
POLYVINYL ACETATE PHTHALATE58QVG85GW3IACT
POVIDONEFZ989GH94EIACT
SHELLAC46N107B71OIACT
SODIUM STARCH GLYCOLATE TYPE A CORNAG9B65PV6BIACT
STEARIC ACID4ELV7Z65APIACT
SUCROSEC151H8M554IACT
TALC7SEV7J4R1UIACT
TITANIUM DIOXIDE15FIX9V2JPIACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
3a6e2839-834b-b126-e063-6394a90adcdbcbee5fd2-4533-4361-ab8f-eb4d52a35e622025-07-21WarningsExact identifier
spl set id: cbee5fd2-4533-4361-ab8f-eb4d52a35e62

Reported adverse events (FAERS/openFDA)#

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