Label at a glance#

ProductLeader 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 display

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDC	Effective	Action	Document	Indexing SPL	Related label
49781-131-16	2020-02-15	C162847	48780-1	9d75b9cf-d694-f424-e053-dadaa90a57ce	DRUG FACTS
49781-131-16	2020-01-31	C162847	48780-1	9d75b9cf-d694-f424-e053-dadaa90a57ce	DRUG FACTS

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDC	Billing unit	Product NDC	DailyMed indexing SPL	SPL version	Effective
49781-131-16	EA - Each	49781-131	6ae2bf84-600e-463f-b71a-ab776be7bb03	1	2017-03-06

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
Ingredient	Type	UNII	SPL version
BISACODYL	ACTIVE INGREDIENT	10X0709Y6I	1
BISACODYL	ACTIVE MOIETY	10X0709Y6I	1
FAT, HARD	INACTIVE INGREDIENT	8334LX7S21	1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 4 matching rows.

Leader Gentle Laxative
Bisacodyl
DEACETYLBISACODYL
FAT, HARD

NDC Codes#

Product NDC, Package NDC table
Product NDC	Package NDC
49781-131	49781-131-16

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
Name	UNII	Kind
BISACODYL	10X0709Y6I	ACTIB
FAT, HARD	8334LX7S21	IACT

Source Document#

Source XML

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 1 · 2 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredient	IID ingredient	UNII	Dosage form / route	Potency	Maximum daily exposure	Match
FAT, HARD	HARD FAT	8334LX7S21	SUPPOSITORY / RECTAL		7657 mg	Exact identifier — unii candidate 2 equally ranked IID candidates
FAT, HARD	HARD FAT	8334LX7S21	CAPSULE / ORAL		153 mg	Exact identifier — unii candidate 2 equally ranked IID candidates

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
Brand	Generic	Manufacturer	SPL set ID	Effective date	Available safety fields	Join
df7b94e6-8578-428a-8fa9-00a0e96712c3			58a32988-3500-4775-afbf-761ee40fa258	2020-02-13	Warnings	Exact identifier spl id: df7b94e6-8578-428a-8fa9-00a0e96712c3 spl set id: 58a32988-3500-4775-afbf-761ee40fa258

Reported adverse events (FAERS/openFDA)#

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