FDA.reportPublic FDA data

Laxative

Manufacturer
Chain Drug Marketing Association, Inc. | Acino Products, LLC
Effective date
2021-05-19
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
full-release
Hydrated at
2026-05-31 23:40:25

Label at a glance#

ProductLaxative
Active ingredientBISACODYL
Label structure12 sections

Indications and uses

For relief of occasional constipation This product generally produces bowel movement in 15 minutes to 1 hour

Dosage and administration

Detach one suppository from the strip and remove from foil Carefully insert one suppository well into the rectum Do not use more than once per day

Storage and handling

Store at room temperature: 15° - 30° C (59° - 86° F) Do not exceed 30° C (86° F) Individually sealed for your protection. Do not use if foil is torn or open.

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each Suppository)

Bisacodyl, 10 mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation
  • This product generally produces bowel movement in 15 minutes to 1 hour

Do not use

OTC - DO NOT USE SECTION

  • more than once per day
  • for a period of longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor
  • if sealed film around the suppository is torn, damaged, or open

Ask a doctor

OTC - ASK DOCTOR SECTION

  • before use if you have noticed a sudden change in bowel habits that persists over a period of two weeks
  • if you are pregnant or nursing a baby

Stop use and ask a doctor

OTC - STOP USE SECTION

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

Directions

DOSAGE & ADMINISTRATION SECTION

01b UC_Bisacodyl Suppository_12pk_DF box_Directions01b UC_Bisacodyl Suppository_12pk_DF box_Directions

  • Detach one suppository from the strip and remove from foil
  • Carefully insert one suppository well into the rectum
  • Do not use more than once per day

Other information

STORAGE AND HANDLING SECTION

  • Store at room temperature: 15° - 30° C (59° - 86° F) Do not exceed 30° C (86° F)
  • Individually sealed for your protection. Do not use if foil is torn or open.

Inactive ingredients

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

Warnings

WARNINGS SECTION

For rectal use only.


May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

01b UC_Bisacodyl Suppository_12pk_PDP01b UC_Bisacodyl Suppository_12pk_PDP

01b UC_Bisacodyl Suppository_12pk_DF box01b UC_Bisacodyl Suppository_12pk_DF box

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN3
198509bisacodyl 10 MG Rectal SuppositorySCD3

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
DEACETYLBISACODYL Pharmacologic Class Indexing2Indexing - Pharmacologic Class20181113

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
e2db08c6-133f-4f4f-afb4-e90a2418d6f6Product name120230320
11ed6f83-cdd2-4637-8379-b1a1d3ae3cdeProduct name120181101
86c45a79-b9f0-4476-a27c-6e10db098497Product name120180125
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
63868-328-082024-01-30C16284748780-19d75b9cf-e20d-f424-e053-dadaa90a57ceChain Drug Marketing Association - Bisacodyl Suppository
63868-328-082021-05-18C16284748780-19d75b9cf-e20d-f424-e053-dadaa90a57ceChain Drug Marketing Association - Bisacodyl Suppository
63868-328-082020-01-31C16284748780-19d75b9cf-e20d-f424-e053-dadaa90a57ceChain Drug Marketing Association - Bisacodyl Suppository

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
63868-328-08Laxative1 in 1 BLISTER PACKSUPPOSITORY13
63868-328-08Laxative8 in 1 BOXSUPPOSITORY83

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
63868-328LAXATIVE (BISACODYL) SUPPOSITORY [CHAIN DRUG MARKETING ASSOCIATION, INC.]3Legacy NDC, 2 package rows20210520_aa8e1cb0-cc92-47e8-8a69-f43da94bede3.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
63868-328-08EA - Each63868-328c24bf773-93de-45b3-9f10-2885ab185f4212014-10-03

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6I1
BISACODYLACTIVE MOIETY10X0709Y6I1
FAT, HARDINACTIVE INGREDIENT8334LX7S211

Products#

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

DailyMed product names page 1 of 1 · 4 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
63868-32863868-328-08

Ingredients#

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

DailyMed ingredient rows page 1 of 1 · 2 matching rows.

Name, UNII, Kind table
NameUNIIKind
FAT, HARD8334LX7S21IACT
BISACODYL10X0709Y6IACTIB

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FAT, HARDHARD FAT8334LX7S21SUPPOSITORY / RECTAL7657 mgExact identifier — unii candidate
2 equally ranked IID candidates
FAT, HARDHARD FAT8334LX7S21CAPSULE / ORAL153 mgExact identifier — unii candidate
2 equally ranked IID candidates

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
c2b0a386-1169-8bd5-e053-2995a90a2eecaa8e1cb0-cc92-47e8-8a69-f43da94bede32021-05-19WarningsExact identifier
spl id: c2b0a386-1169-8bd5-e053-2995a90a2eec
spl set id: aa8e1cb0-cc92-47e8-8a69-f43da94bede3

Reported adverse events (FAERS/openFDA)#

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