FDA.reportPublic FDA data

Premier Value Bisacodyl Laxative

Manufacturer
Chain Drug Consortium | Unipack, Inc.
Effective date
2015-03-25
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:42:04

Label at a glance#

ProductPremier Value Bisacodyl Laxative
Active ingredientBISACODYL
Label structure14 sections

Indications and uses

Uses - For relief of occasional constipation -this product generally produces bowel movement in 1/4 hour to 1 hour 

Dosage and administration

-adults and children 12 years of age and older - detach one suppository from the strip -remove from wrapper before inserting into the rectum - the rectal suppository dose is one suppository per day or as directed by a doctor - children under 12 years of age consult a doctor.

Storage and handling

Other information store below 30 o C (86 o F)

Label contents#

Full prescribing information#

Active Ingredient (in each Suppository)

OTC - ACTIVE INGREDIENT SECTION

Active Ingredient (in each Suppository)        Purpose

Bisacodyl USP, 10 mg.................................Laxative

Uses

INDICATIONS & USAGE SECTION

Uses - For relief of occasional constipation -this product generally produces bowel movement in 1/4 hour to 1 hour 

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

Do not use 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

Ask a doctor before use if you have noticed a sudden change in bowel movement

burning and mild cramps

When using this product

OTC - WHEN USING SECTION

When using this product it may cause abdominal discomfort, faintness, rectal burning, and mild cramps

Stop use and ask a doctor

OTC - STOP USE SECTION

Stop use and ask a doctor if rectal bleeding occurs, or you fail to have bowel movement after using a laxative.  This may indicate 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.  If swallowed, get medical help or contact a Poison Control Center right away.

Directions

DOSAGE & ADMINISTRATION SECTION

-adults and children 12 years of age and older - detach one suppository from the strip

-remove from wrapper before inserting into the rectum - the rectal suppository dose is one suppository per day or as directed by a doctor - children under 12 years of age consult a doctor.

Other information

STORAGE AND HANDLING SECTION

Other information

store below 30oC (86oF)

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredient  

hydrogenated vegetable oil

Purpose

OTC - PURPOSE SECTION

Active Ingredient (in each Suppository)         Purpose
Bisacodyl USP, 10 mg.................................Laxative

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

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
BISACODYL Pharmacologic Class Indexing1Indexing - Pharmacologic Class20101101

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
89dac932-b90a-4410-9ab1-84c53e57de25Product name120150316

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
68016-306-092020-01-31C16284748780-19d75b9d0-de22-f424-e053-dadaa90a57ceb98997b8-1158-4d88-b3ad-da767f203bbf

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
68016-306-08Premier Value Bisacodyl Laxative40 mg in 1 BLISTER PACKSUPPOSITORY401
68016-306-09Premier Value Bisacodyl Laxative2 in 1 PACKAGESUPPOSITORY21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
68016-306PREMIER VALUE BISACODYL LAXATIVE (BISACODYL SUPPOSITORY) SUPPOSITORY [CHAIN DRUG CONSORTIUM]1Legacy NDC, 2 package rows20150326_b98997b8-1158-4d88-b3ad-da767f203bbf.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
68016-306-08EA - Each68016-306abd458fa-36af-4ed7-8c59-6e92f0dba2c612022-06-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6I1
BISACODYLACTIVE MOIETY10X0709Y6I1
PALM KERNEL OILINACTIVE INGREDIENTB0S90M02331

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
68016-30668016-306-08, 68016-306-09

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
PALM KERNEL OILB0S90M0233IACT

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
86386976-d5c5-4d5e-bab6-28825037e677b98997b8-1158-4d88-b3ad-da767f203bbf2015-03-25WarningsExact identifier
spl id: 86386976-d5c5-4d5e-bab6-28825037e677
spl set id: b98997b8-1158-4d88-b3ad-da767f203bbf

Reported adverse events (FAERS/openFDA)#

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