FDA.reportPublic FDA data

BISAC-EVAC

Manufacturer
Cosette Pharmaceuticals, Inc.
Effective date
2019-08-20
Label type
HUMAN OTC DRUG LABEL
Version
2
Source
legacy-cache
Hydrated at
2026-08-02 00:14:57

Label at a glance#

ProductBISAC-EVAC
Active ingredientBISACODYL
Label structure10 sections

Indications and uses

For the relief of occasional constipation. Bowel movement is generally produced in 15 minutes to 1 hour.

Dosage and administration

• see chart below for dose • remove foil wrapper • insert suppository well up into the rectum as indicated, and retain it about 15 to 20 minutes adults and children 12 years and over 1 suppository once daily. children 6 years to under 12 years 1/2 suppository once daily children under 6 years ask a doctor • In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum je...

Label contents#

Full prescribing information#

ACTIVE INGREDIENT (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 10 mg

PURPOSE

OTC - PURPOSE SECTION

Laxative

USES

INDICATIONS & USAGE SECTION

For the relief of occasional constipation.
Bowel movement is generally produced in 15 minutes to 1 hour.

WARNINGS

WARNINGS SECTION

For rectal use only

Do not use laxative products for a period longer than one week unless directed by a doctor

Ask a doctor before use if you have
• abdominal pain, nausea or vomiting
• a sudden change in bowel habits that lasts longer than 2 weeks

Stop use and ask a doctor if rectal bleeding occurs or you fail to have a bowel movement after using a laxative. These may be signs of a serious condition.

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

• see chart below for dose
• remove foil wrapper
• insert suppository well up into the rectum as indicated, and retain it about 15 to 20 minutes

adults and children 12 years and over

1 suppository once daily.

children 6 years to under 12 years

1/2 suppository once daily

children under 6 years

ask a doctor

• In the presence of anal fissures or hemorrhoids, suppositories should be coated at the tip with petroleum jelly.

OTHER INFORMATION

SPL UNCLASSIFIED SECTION

Store at room temperature

INACTIVE INGREDIENT

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

NDC 0713-0109-08
G&W®
BISAC-EVAC™
Bisacodyl USP LAXATIVE
8 SUPPOSITORIES 10 mg each

Unit Carton
Unit Carton

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0713-0109-01EA - Each0713-0109a24d5b04-b98b-4320-8d58-8798644e4c6412013-02-13
0713-0109-05EA - Each0713-0109b9916a49-a99b-4e13-b96f-00267cb6cce612013-02-13
0713-0109-08EA - Each0713-0109c90b775d-b3c4-47da-9b24-25a33c01a71412013-02-13
0713-0109-10EA - Each0713-01096baa5398-e764-4939-af4e-7aea56d7450a12013-02-13
0713-0109-12EA - Each0713-01096af07ebf-ab99-4469-b0b1-e6dfaa2b405a12013-02-13
0713-0109-50EA - Each0713-01095351c6f4-b000-44da-bf60-2ce5dda6e1a912013-02-13

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BisacodylACTIVE INGREDIENT10X0709Y6I1
BisacodylACTIVE MOIETY10X0709Y6I1
Hydrogenated Palm Kernel OilINACTIVE INGREDIENTFM8D1RE2VP1

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
0713-01090713-0109-12, 0713-0109-01, 0713-0109-08, 0713-0109-50, 0713-0109-05, 0713-0109-10

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
HYDROGENATED PALM KERNEL OILFM8D1RE2VPIACT

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
8bc0e424-2449-41ef-9901-f9cb8a55be91fc6dc813-717e-5e5c-4b72-9e46e40e9c402021-06-26WarningsExact identifier
spl set id: fc6dc813-717e-5e5c-4b72-9e46e40e9c40

Reported adverse events (FAERS/openFDA)#

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