Bisacodyl

Manufacturer
A-S Medication Solutions
Effective date
2020-12-21
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 23:35:40

Label at a glance#

ProductBisacodyl
Active ingredientBISACODYL
Label structure16 sections

Storage and handling

Other information store at temperatures below 25 C (77F) Made in India

Label contents#

Full prescribing information#

SPL UNCLASSIFIED SECTION

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each suppository)

Bisacodyl USP, 10 mg

OTC - PURPOSE SECTION

Purpose

Stimulant Laxative

INDICATIONS & USAGE SECTION

Uses

  • relieves occasional constipation
  • this product generally produces a bowel movement in 15 minutes to 1 hour

WARNINGS SECTION

Warnings

For rectal use only

OTC - DO NOT USE SECTION

Do not use

when abdominal pain, nausea, or vomiting are present.

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have a sudden change in bowel habits that lasts over a period 2 weeks.

OTC - WHEN USING SECTION

When using this product you may experience

  • rectal burning
  • mild cramps
  • abdominal discomfort
  • faintness

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • you have rectal bleeding or you fail to have bowel movement after using a laxative. These may be signs of a serious condition.
  • you need to use a laxative product for more than one week

OTC - PREGNANCY OR BREAST FEEDING SECTION

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

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.

DOSAGE & ADMINISTRATION SECTION

Directions

  • tear off one suppository from the strip
  • peel apart the wrapper
  • continue peeling apart to almost the full length of the suppository (see illustration at the right)
  • gently remove the suppository from the wrapper
  • lie on your side and push suppository, with pointed end first, high into the rectum so it will not slip out
  • retain it for about 15 to 20 minutes.
  • Do not exceed recommended dose
  • if suppository seems soft, place in refrigerator for a short time before use

adults and children 12 years and over

1 suppository once daily

children under 12 yearsAsk a doctor

STORAGE AND HANDLING SECTION

Other information

  • store at temperatures below 25 C (77F)
  • Made in India

INACTIVE INGREDIENT SECTION

Inactive ingredient hard fat

OTC - QUESTIONS SECTION

Questions or Comments? 1-800-540-3765

HOW SUPPLIED

HOW SUPPLIED SECTION

Product: 50090-5385

NDC: 50090-5385-0 6 SUPPOSITORY in a BLISTER PACK

BISACODYL SUPPOSITORY

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label Image
Label Image

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN1
198509bisacodyl 10 MG Rectal SuppositorySCD1

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
50090-5385-02023-01-30C16284748780-1f386c64a-1997-0266-e053-dadaa90a7c1aBisacodyl Suppositories

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
50090-5385-0Bisacodyl6 in 1 BLISTER PACKSUPPOSITORY61

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
50090-5385BISACODYL SUPPOSITORY [A-S MEDICATION SOLUTIONS]1Legacy NDC, 1 package rows20201222_a199ea53-20b3-4aae-a3f4-265b50c96de5.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
57896-443-05EA - Each57896-44341c7bf1c-6922-4f95-9b3a-d556aaef79c412020-07-13

Products#

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

DailyMed product names page 1 of 1 · 3 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
50090-538550090-5385-0
57896-443

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

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
BisacodylBISACODYLGERI-CARE PHARMACEUTICAL CORPa747a57a-028e-70ea-e053-2a95a90ac1842025-10-23WarningsExact identifier
ndc (product): 57896-443
0b151d02-d09d-473d-b144-63d31239ba3ba199ea53-20b3-4aae-a3f4-265b50c96de52020-12-21WarningsExact identifier
spl id: 0b151d02-d09d-473d-b144-63d31239ba3b
spl set id: a199ea53-20b3-4aae-a3f4-265b50c96de5

Reported adverse events (FAERS/openFDA)#

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