Bisacodyl

Manufacturer
REMEDYREPACK INC.
Effective date
2022-03-15
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
legacy-cache
Hydrated at
2026-08-01 22:06:07

Label at a glance#

ProductBisacodyl
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 adults and children 12 years 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 ask a doctor

Storage and handling

store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F) avoid excessive humidity use by expiration date on package

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 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

OTC - DO NOT USE SECTION

if you cannot swallow without chewing.

Ask a doctor before use if you have

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

If pregnant or breast-feeding,

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 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 overtake 1 to 3 tablets in a single daily dose
children 6 to under 12 yearstake 1 tablet in a single daily dose
children under 6 yearsask a doctor

Other information

STORAGE AND HANDLING SECTION

  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • use by expiration date on package

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 or comments?

OTC - QUESTIONS SECTION

(800)-616-2471

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

DRUG: Bisacodyl

GENERIC: Bisacodyl

DOSAGE: TABLET, COATED

ADMINSTRATION: ORAL

NDC: 70518-1864-0

NDC: 70518-1864-1

COLOR: orange

SHAPE: ROUND

SCORE: No score

SIZE: 6 mm

IMPRINT: 5

PACKAGING: 30 in 1 BLISTER PACK

PACKAGING: 30 in 1 BLISTER PACK

ACTIVE INGREDIENT(S):

  • BISACODYL 5mg in 1

INACTIVE INGREDIENT(S):

  • POVIDONE, UNSPECIFIED
  • TRIACETIN
  • TITANIUM DIOXIDE
  • TALC
  • SUCROSE
  • STEARIC ACID
  • SODIUM BICARBONATE
  • SODIUM BENZOATE
  • SODIUM ALGINATE
  • WATER
  • DIMETHICONE
  • SHELLAC
  • PROPYLPARABEN
  • PROPYLENE GLYCOL
  • TRIETHYL CITRATE
  • AMMONIA
  • POLYETHYLENE GLYCOL, UNSPECIFIED
  • POLYDEXTROSE
  • METHYLPARABEN
  • MAGNESIUM STEARATE
  • ANHYDROUS LACTOSE
  • FERROSOFERRIC OXIDE
  • HYPROMELLOSE, UNSPECIFIED
  • FD&C YELLOW NO. 6
  • D&C YELLOW NO. 10 ALUMINUM LAKE
  • STARCH, CORN
  • SILICON DIOXIDE
  • CARNAUBA WAX
  • CALCIUM CARBONATE
  • Polyvinyl Acetate Phthalate
  • ACACIA

Remedy_LabelRemedy_Label

MM2MM2

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
70518-1864-02025-07-31C16284748780-11030e365-3e91-111a-e063-dadaa90a10e2Major 44-327
70518-1864-12025-07-31C16284748780-11030e365-3e91-111a-e063-dadaa90a10e2Major 44-327
70518-1864-02024-01-30C16284748780-11030e365-3e91-111a-e063-dadaa90a10e2Major 44-327
70518-1864-12024-01-30C16284748780-11030e365-3e91-111a-e063-dadaa90a10e2Major 44-327

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
70518-1864BISACODYL TABLET, COATED [REMEDYREPACK INC.]6Legacy NDC20220316_f8e9ff6d-9627-41ca-b8ee-c3f3705e6bb9.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6748-17EA - Each0904-67484ad50450-99a7-40b2-99ea-4f1812c5b8c712019-02-13
0904-6748-60EA - Each0904-67485fe1e51f-a913-40d6-87f6-860c57fcac9612018-12-13
0904-6748-80EA - Each0904-674880e9234e-96db-4f38-8270-ce64e0dce73612018-12-13

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
70518-186470518-1864-0, 70518-1864-1
0904-6748

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 32 matching rows.

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
BisacodylBISACODYLMajor Pharmaceuticals6b85af55-35db-4630-8bc0-9ff4fbf5990a2025-11-19WarningsExact identifier
ndc (product): 0904-6748
079a8e12-0aed-096d-e063-6294a90afc0bf8e9ff6d-9627-41ca-b8ee-c3f3705e6bb92023-10-13WarningsExact identifier
spl set id: f8e9ff6d-9627-41ca-b8ee-c3f3705e6bb9

Reported adverse events (FAERS/openFDA)#

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