TopCare Gentle Laxative

Manufacturer
Topco Associates LLC | Reese Pharmaceutical Co | Biopharm
Effective date
2017-08-30
Label type
HUMAN OTC DRUG LABEL
Version
1
Source
full-release
Hydrated at
2026-05-31 22:54:49

Label at a glance#

ProductTopCare Gentle Laxative
Active ingredientBISACODYL
Label structure13 sections

Indications and uses

For 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 suppositry well into the rectum -Do not use more tha...

Storage and handling

 do not store above 30°C (86°F)

Label contents#

Full prescribing information#

Active ingredient

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP, 10 mg


Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Uses

INDICATIONS & USAGE SECTION

  • For 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.

OTC - ASK DOCTOR SECTION

  • stomach pain, nausea or vomiting
  • noticed a sudden change in bowel habits that persists over a period of two weeks

When using this product

OTC - WHEN USING SECTION

May cause abdominal discomfort, faintness, rectal burning, and mild cramps

OTC - STOP USE SECTION

Stop use and ask a doctor if

  • if you have rectal bleeding or fail to have bowel movement after using a laxative. This may indicate a serious condition
  • you need to use a laxative for more than 1 week

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

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 suppositry well into the rectum

-Do not use more than once per day

Other Information

STORAGE AND HANDLING SECTION

  •  do not store above 30°C (86°F)

Inactive Ingredients

INACTIVE INGREDIENT SECTION

hydrogenated vegetable oil

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

image of displayimage of display

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
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
36800-808-082020-01-31C16284748780-19d75b9d0-c127-f424-e053-dadaa90a57ceDRUG FACTS

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
36800-808-08TopCare Gentle Laxative40 mg in 1 BLISTER PACKSUPPOSITORY401
36800-808-08TopCare Gentle Laxative2 in 1 CARTONSUPPOSITORY21

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
36800-808TOPCARE GENTLE LAXATIVE (BISACODYL ) SUPPOSITORY [TOPCO ASSOCIATES LLC]1Legacy NDC, 2 package rows20180302_11eeb713-4f7d-4965-b12b-6798b23b96f6.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
36800-80836800-808-08

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
e64fc896-056a-4ab3-80db-e07559e2130111eeb713-4f7d-4965-b12b-6798b23b96f62017-08-30WarningsExact identifier
spl id: e64fc896-056a-4ab3-80db-e07559e21301
spl set id: 11eeb713-4f7d-4965-b12b-6798b23b96f6

Reported adverse events (FAERS/openFDA)#

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