Leader Gentle Laxative

Manufacturer
Major Pharmaceuticals | Unipack LLC
Effective date
2024-06-14
Label type
HUMAN OTC DRUG LABEL
Version
5
Source
legacy-cache
Hydrated at
2026-08-01 21:00:39

Label at a glance#

ProductLeader Gentle Laxative
Active ingredientBISACODYL
Label structure15 sections

Indications and uses

Uses - For temporary 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, pointed end first - Retain about 15 to 20 minutes

Storage and handling

Other information - Storage temperature: not to exceed 30 o C (86 o F) - Lot No. & Exp. Date: see wrapper or box

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 temporary 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  - laxative products when abdominal pain, nausea, or vomiting are present unless directed by a doctor- for a period of longer than one week 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. (1-800-222-1222) 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, pointed end first

- Retain about 15 to 20 minutes

Other information

STORAGE AND HANDLING SECTION

Other information - Storage temperature: not to exceed 30 oC (86 oF)

- Lot No. & Exp. Date: see wrapper or box

Inactive ingredient

INACTIVE INGREDIENT SECTION

Inactive ingredient  Hydrogenated vegetable oil

Purpose

OTC - PURPOSE SECTION

Stimulant Laxative

Qutestions?

OTC - QUESTIONS SECTION

Questions? 1-724-733-7381

Product Label

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Product LabelProduct Label

FDA-Initiated Inactive NDC Indexing#

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
0904-6981-12EA - Each0904-69812307dd76-2494-48db-8349-c31ddeaa85e912019-11-12
0904-6981-60EA - Each0904-6981a03b3982-e75d-41d0-a5e0-477482c6d7ac12019-11-12

Products#

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

DailyMed product names page 1 of 1 · 5 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
0904-69810904-6981-13, 0904-6981-12

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
1ad12b1c-e092-fd30-e063-6394a90a8f3c97a3a84f-a7cb-4db3-a40c-5932ef4e80ca2024-06-14WarningsExact identifier
spl id: 1ad12b1c-e092-fd30-e063-6394a90a8f3c
spl set id: 97a3a84f-a7cb-4db3-a40c-5932ef4e80ca

Reported adverse events (FAERS/openFDA)#

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