FDA.reportPublic FDA data

Bisacodyl Laxative

Manufacturer
Good Sense
Effective date
2021-06-18
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
legacy-cache
Hydrated at
2026-08-01 22:43:16

Label at a glance#

ProductBisacodyl Laxative
Active ingredientBISACODYL
Label structure10 sections

Dosage and administration

take with a glass of water adults and children 12 years of age 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 of age:  ask a doctor

Storage and handling

store between 68º to 77ºF (20º to 25ºC)

Label contents#

Full prescribing information#

Active ingredient(s)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 5mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Use(s)

INDICATIONS & USAGE SECTION

  • for temporary 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

you cannot swallow without chewing

Ask a doctor before use if

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
  • you may have 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

Pregnancy/Breastfeeding

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 accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

DOSAGE & ADMINISTRATION SECTION

  • take with a glass of water

adults and children 12 years of age 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 of age: ask a doctor

Other information

SPL UNCLASSIFIED SECTION

do not use if blister unit is broken or torn

Storage

STORAGE AND HANDLING SECTION

store between 68º to 77ºF (20º to 25ºC)

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

OTC - QUESTIONS SECTION

Call 1-800-719-9260 Monday through Friday 9AM – 5PM

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl LaxativeBisacodyl Laxative

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
50804-40450804-404-92

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
BISACODYL10X0709Y6IACTIB
ACACIA5C5403N26OIACT
AMMONIA5138Q19F1XIACT
CALCIUM CARBONATEH0G9379FGKIACT
CARNAUBA WAXR12CBM0EIZIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
STARCH, CORNO8232NY3SJIACT
D&C YELLOW NO. 10 ALUMINUM LAKECQ3XH3DET6IACT
FD&C YELLOW NO. 6H77VEI93A8IACT
HYPROMELLOSES3NXW29V3WOIACT
FERROUS OXIDEG7036X8B5HIACT
ANHYDROUS LACTOSE3SY5LH9PMKIACT
MAGNESIUM STEARATE70097M6I30IACT
METHYLPARABENA2I8C7HI9TIACT
POLYDEXTROSEVH2XOU12IEIACT
POLYETHYLENE GLYCOL, UNSPECIFIED3WJQ0SDW1AIACT
Polyvinyl Acetate Phthalate58QVG85GW3IACT
POVIDONEFZ989GH94EIACT
PROPYLENE GLYCOL6DC9Q167V3IACT
PROPYLPARABENZ8IX2SC1OHIACT
SHELLAC46N107B71OIACT
TRIMETHYLSILANE9L70DJH2K0IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
280c9fbe-dbd6-4c51-98d1-5164a6b5ae1ad05ba873-2603-47a2-9ae6-e5773f4a64ef2021-06-18WarningsExact identifier
spl set id: d05ba873-2603-47a2-9ae6-e5773f4a64ef

Reported adverse events (FAERS/openFDA)#

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