FDA.reportPublic FDA data

LAXATIVE

Manufacturer
GRAXCELL PHARMACEUTICAL, LLC
Effective date
2025-12-25
Label type
HUMAN OTC DRUG LABEL
Version
6
Source
full-release
Hydrated at
2026-06-01 01:28:42

Label at a glance#

ProductLAXATIVE
Active ingredientBISACODYL
Label structure8 sections

Indications and uses

For relief of occasional constipation This product generally produces bowel movement in 15 minutes to 1 hour

Dosage and administration

Detach one suppository from the strip and remove from foil Carefully insert one supoository well into the rectum Do not use more than once per day

Storage and handling

store below 30° C (86° F)

Label contents#

Full prescribing information#

Active Ingredient (in each suppository)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl, 10  mg

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

  • For relief of occasional constipation
  • This product generally produces bowel movement in 15 minutes to 1 hour

Warnings

WARNINGS SECTION

For rectal use only. ​May cause abdominal discomfort, faintness, rectal burning, and mild cramps.

Do not use

OTC - DO NOT USE SECTION

  • more than once per day
  • for a period longer than one week unless directed by a doctor
  • laxative products when abdominal pain, nausea, or vomitting are present unless directed by a doctor
  • if sealed film around the suppository is torn, damaged, or open.

Ask a doctor

OTC - ASK DOCTOR SECTION

  • before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks
  • if you are pregnant or nursing a baby

Stop use and ask a doctor

OTC - STOP USE SECTION

if you have rectal bleeding or fail to have a bowel movement after using a laxative. This may indicate a serious condition.

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

TableTable

  • Detach one suppository from the strip and remove from foil
  • Carefully insert one supoository well into the rectum
  • Do not use more than once per day

Other information

STORAGE AND HANDLING SECTION

store below 30° C (86° F)

Inactive ingredient

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Label 1Label 1

Label 2Label 2

Label 3Label 3

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYSPL version
198509bisacodyl 10 MG Rectal SuppositoryPSN6
198509bisacodyl 10 MG Rectal SuppositorySCD6

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
70795-1010-12025-12-26C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52025-12-26C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82025-12-26C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-12024-01-30C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52024-01-30C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82024-01-30C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-12020-11-16C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52020-11-16C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82020-11-16C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-12020-01-31C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-52020-01-31C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010
70795-1010-82020-01-31C16284748780-19d75b9d0-e302-f424-e053-dadaa90a57ceLAXATIVE SUPPOSITORIES, 70795-1010

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
70795-1010-1LAXATIVE100 in 1 PACKAGESUPPOSITORY1006
70795-1010-1LAXATIVE1 in 1 BLISTER PACKSUPPOSITORY16
70795-1010-5LAXATIVE50 in 1 BOXSUPPOSITORY506
70795-1010-5LAXATIVE1 in 1 BLISTER PACKSUPPOSITORY16
70795-1010-8LAXATIVE1 in 1 BLISTER PACKSUPPOSITORY16
70795-1010-8LAXATIVE8 in 1 BOXSUPPOSITORY86

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
70795-1010-1EA - Each70795-1010feb8228f-67b4-4f76-b795-aaec965ecdda12017-10-13
70795-1010-5EA - Each70795-1010e6ba232c-9924-4530-b835-c091e95aa86512017-10-13
70795-1010-8EA - Each70795-101046df6db7-0319-43ed-97b8-5696578b525412017-10-13

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
70795-101070795-1010-8, 70795-1010-5, 70795-1010-1

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 · Source PDF

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
LAXATIVEBISACODYLGRAXCELL PHARMACEUTICAL, LLC5a65d4ab-447f-42bb-b38d-070db523b8062025-12-25WarningsExact identifier
ndc (package): 70795-1010-1
ndc (package): 70795-1010-8
ndc (package): 70795-1010-5
ndc (product): 70795-1010
ndc11 (package): 70795101001
ndc11 (package): 70795101005
ndc11 (package): 70795101008
spl id: 46d42c6c-5340-c5b9-e063-6394a90a539e
spl set id: 5a65d4ab-447f-42bb-b38d-070db523b806

Reported adverse events (FAERS/openFDA)#

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