FDA.reportPublic FDA data

Bisacodyl Laxative Suppositories

Manufacturer
InvaDerm Corporation
Effective date
2026-08-10
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
daily-update
Hydrated at
2026-09-03 03:04:44

Label at a glance#

ProductBisacodyl Laxative
Active ingredientBISACODYL
Label structure8 sections

Dosage and administration

detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows: hold suppository with pointed end up carefully separate tabs with fingernail slowly pull apart by pulling tabs down on both side remove suppository from wrapper (see illustration at the right) gently remove the suppository from the wrapper lie on your side and push suppository, pointed end first, high into the rectum s...

Label contents#

Full prescribing information#

Activeingredient(in eachsuppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl (USP) 10 mg

Purpose

OTC - PURPOSE SECTION

Stimulant laxative

Use

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation and irregularity
  • this product generally produces bowel movement in 1/4 to 1 hour

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

WARNINGS SECTION

laxative products

  • when abdominal pain, nausea, or vomiting are present
  • for a period longer than 1 week

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

noticed a sudden change in bowel habits that lasts more than 2 weeks

When using this product

OTC - WHEN USING SECTION

it may cause abdominal discomfort, faintness, rectal burning and mild cramps

Stop use and ask a doctor if

OTC - STOP USE SECTION

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

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

Directions

DOSAGE & ADMINISTRATION SECTION

  • detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows:
  • hold suppository with pointed end up
  • carefully separate tabs with fingernail
  • slowly pull apart by pulling tabs down on both side
  • remove suppository from wrapper (see illustration at the right)
  • gently remove the suppository from the wrapper
  • lie on your side and push suppository, pointed end first, high into the rectum so it will not slip out
  • retain it for 15 to 20 minutes
  • Do not exceed recommended dose
  • if suppository seems soft, place in refrigerator for short time before use

directionsdirections

Adults and children 12 years and over1 suppository once daily
Children under 12 yearsAsk a doctor

Other information

SPL UNCLASSIFIED SECTION

  • store at temperature below 30°(86°F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PRINCIPAL DISPLAY PANEL

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Bisacodyl USP 10 mg
12 SUPPOSITORIES 12ct12ct

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
71457-50171457-501-12, 71457-501-24, 71457-501-50, 71457-501-01

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
BISACODYL10X0709Y6IACTIB
FAT, HARD8334LX7S21IACT

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 LaxativeBISACODYLInvaDerm Corporation58ba9a9f-98d8-c380-e063-6294a90a774c2026-08-10WarningsExact identifier
ndc (package): 71457-501-50
ndc (package): 71457-501-12
ndc (package): 71457-501-01
ndc (package): 71457-501-24
ndc (product): 71457-501
ndc11 (package): 71457050112
ndc11 (package): 71457050124
ndc11 (package): 71457050150
ndc11 (package): 71457050101
spl id: 58ba9aae-1643-b2d1-e063-6394a90acbc0
spl set id: 58ba9a9f-98d8-c380-e063-6294a90a774c

Reported adverse events (FAERS/openFDA)#

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