Avedana Gentle Laxative

Manufacturer
Unipack LLC
Effective date
2024-11-26
Label type
HUMAN OTC DRUG LABEL
Version
8
Source
full-release
Hydrated at
2026-06-01 00:39:37

Label at a glance#

ProductAvedana Gentle Laxative
Active ingredientBISACODYL
Label structure14 sections

Indications and uses

Uses - For temporarily relief of occasional constipation and irregularity -This product generally produces bowel movement in 15 minutes to 1 hour

Dosage and administration

Adults and children 12 years of age and older              Children 6 to under 12 years                 Children under 6 One suppository once daily                                         1/2 suppository once daily                    Ask doctor. -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

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

Label contents#

Full prescribing information#

Active Ingredient (in each Suppository)

OTC - ACTIVE INGREDIENT SECTION

                                                                   Purpose

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

Uses

INDICATIONS & USAGE SECTION

Uses - For temporarily relief of occasional constipation and irregularity

-This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

WARNINGS SECTION

For rectal use only.

Do not use

OTC - DO NOT USE SECTION

Do not use - 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

Ask a doctor

OTC - ASK DOCTOR SECTION

Ask a doctor before use if you have - noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

OTC - WHEN USING SECTION

When using this product - 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 you have rectal bleeding or 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              Children 6 to under 12 years                 Children under 6

One suppository once daily                                         1/2 suppository once daily                    Ask doctor.

-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

Other information - Store at room temperature: 15 o - 30 oC (59 o - 86 oF). Do not exceed 30 oC (86 oF) - Individually sealed for your protection.  Do not use if foil is torn or open

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredient  Hydrogenated vegetable oil

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Avedana ® Bisacodyl Suppositories

Product LabelProduct Label

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN8
198509bisacodyl 10 MG Rectal SuppositorySCD8

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

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
43749-460-16Avedana Gentle Laxative4 in 1 CARTONSUPPOSITORY48
43749-460-17Avedana Gentle Laxative4 in 1 BLISTER PACKSUPPOSITORY48

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
43749-460AVEDANA GENTLE LAXATIVE (BISACODYL) SUPPOSITORY [UNIPACK LLC]8Legacy NDC, 2 package rows20241128_e2824884-515a-4a87-bffe-c9d0e97c6c8b.zip

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
43749-46043749-460-17, 43749-460-16

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
PALM KERNEL OILB0S90M0233IACT
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 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
27dda4fc-fa62-60aa-e063-6394a90a4a99e2824884-515a-4a87-bffe-c9d0e97c6c8b2024-11-26WarningsExact identifier
spl id: 27dda4fc-fa62-60aa-e063-6394a90a4a99
spl set id: e2824884-515a-4a87-bffe-c9d0e97c6c8b

Reported adverse events (FAERS/openFDA)#

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