Bisacodyl 5mg

Manufacturer
Allegiant Health
Effective date
2019-03-26
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
full-release
Hydrated at
2026-06-01 00:56:51

Label at a glance#

ProductBisacodyl 5mg
Active ingredientBISACODYL
Label structure8 sections

Indications and uses

for relief of occasional constipation (irregularity) this product generally produces bowel movement in 6 to 12 hours

Dosage and administration

take with water  Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily Children 6 to 12 years of age: take 1 tablet once a day Children under 6 years of age: consult a doctor

Label contents#

Full prescribing information#

Active Ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 5mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation (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 are unable to swallow without chewing
  • within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

  • do not chew or crush tablets
  • abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you need to use more than 1 week
  • rectal bleeding or failure to have a bowel movement after use of a laxative.

These may be signs of a serious condition.

If pregnant or breast-feeding

OTC - PREGNANCY OR BREAST FEEDING SECTION

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children. 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 water 

Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily

Children 6 to 12 years of age: take 1 tablet once a day

Children under 6 years of age: consult a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store between 68º to 77ºF (20º to 25ºC)
  • do not use blister unit is broken or torn

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl acetate pthalate, polydextrose, polyethylene glycol, propylparaben, propylene glycol, povidone, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl 5mg PinkBisacodyl 5mg Pink

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
b0cbf770-6cc3-4aa4-9158-755110c2b9f7Product name220230717
dc7c5daa-021f-40dd-b00d-63982cb2067aProduct name120230426
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
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
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
69168-398-02Bisacodyl 5mg150 in 1 BOTTLETABLET, COATED1504
69168-398-03Bisacodyl 5mg250 in 1 BOTTLETABLET, COATED2504
69168-398-92Bisacodyl 5mg25 in 1 BLISTER PACKTABLET, COATED254
69168-398-92Bisacodyl 5mg1 in 1 CARTONTABLET, COATED14

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
69168-398BISACODYL 5MG TABLET, COATED [ALLEGIANT HEALTH]4Current NDC, Legacy NDC, 4 package rows20250309_46a377f5-822b-496f-a73b-66d8f902680a.zip

Products#

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

DailyMed product names page 1 of 1 · 30 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
69168-39869168-398-92, 69168-398-02, 69168-398-03

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 28 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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
Bisacodyl 5mgBISACODYL 5MGAllegiant Health46a377f5-822b-496f-a73b-66d8f902680a2019-03-26WarningsExact identifier
ndc (package): 69168-398-03
ndc (package): 69168-398-02
ndc (package): 69168-398-92
ndc (product): 69168-398
ndc11 (package): 69168039803
ndc11 (package): 69168039802
ndc11 (package): 69168039892
spl id: f9cf5e5e-55b8-4786-b5d8-c39319823011
spl set id: 46a377f5-822b-496f-a73b-66d8f902680a

Reported adverse events (FAERS/openFDA)#

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