LEADER WOMENS LAXATIVE

Manufacturer
Cardinal Health
Effective date
2021-01-22
Label type
HUMAN OTC DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 22:55:22

Label at a glance#

ProductLEADER WOMENS LAXATIVE
Active ingredientBISACODYL
Label structure9 sections

Indications and uses

▪ for relief of occasional constipation and irregularity

Dosage and administration

adults and children 12 years of age and over take 1 to 3 tablets in a single dose once daily children 6 to under 12 years of age take 1 tablet in a single dose once daily children under 6 years of age ask a doctor

Storage and handling

▪ do not use if individual blister compartments are broken or open ▪ Store at room temperature ▪ Protect from moisture ▪ Retain carton for complete information

Label contents#

Full prescribing information#

Active ingredient (in each tablet)

OTC - ACTIVE INGREDIENT SECTION

Bisacodyl USP 5 mg

Purpose

OTC - PURPOSE SECTION

Laxative

Uses

INDICATIONS & USAGE SECTION

  • for relief of occasional constipation and irregularity

Warnings

WARNINGS SECTION

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • abdominal pain
  • nausea
  • vomiting
  • a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

OTC - WHEN USING SECTION

  • you may experience stomach discomfort, faintness, and cramps may occur
  • Swallow tablets whole, do not chew or crush
  • do not use within 1 hour after taking an antacid or milk
  • expect results in 6-12 hours

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • you fail to have a bowel movement after use
  • rectal bleeding occurs
  • you need to use a laxative for more than one week

If pregnant or breast-feeding,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children.

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

In case of overdose, get medical help or contact a Poison Control Center Immediately.

Directions

DOSAGE & ADMINISTRATION SECTION

adults and children 12 years of age and over

take 1 to 3 tablets in a single dose once daily

children 6 to under 12 years of age

take 1 tablet in a single dose once daily

children under 6 years of age

ask a doctor

Other information

STORAGE AND HANDLING SECTION

  • do not use if individual blister compartments are broken or open
  • Store at room temperature
  • Protect from moisture
  • Retain carton for complete information

Inactive ingredients

INACTIVE INGREDIENT SECTION

acacia, calcium sulfate anhydrous, carnauba wax, colloidal silicon dioxide, corn starch, D&C red #7 calcium lake, hypromellose phthalate, Iron oxide, Iron oxide black, Iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin.

Questions or comments?

OTC - QUESTIONS SECTION

1-800-719-9260

Principal Display Panel

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Compare to Correctol® Tablets active ingredient

Women’s Laxative

Bisacodyl USP 5 mg

For Gentle, Dependable Overnight Relief

For Gentle, Overnight Relief from Irregularity

SATISFACTION GUARANTEED

30 COATED TABLETS

Distributed By:

Cardinal Health

Dublin, Ohio 43017

www.myleader.com

CIN 2712586

Women's Laxative Carton
Women's Laxative Carton

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
37205-298-652025-04-11C16284748780-1f386c64a-1e74-0266-e053-dadaa90a7c1aCardinal Health Women's Laxative Drug Facts
37205-298-652023-01-30C16284748780-1f386c64a-1e74-0266-e053-dadaa90a7c1aCardinal Health Women's Laxative Drug Facts

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
37205-298-65EA - Each37205-298b545d48b-07d4-402d-bb9d-2cb48a4632c112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
BISACODYLACTIVE INGREDIENT10X0709Y6I1
BISACODYLACTIVE MOIETY10X0709Y6I1

Products#

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

DailyMed product names page 1 of 1 · 25 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
37205-29837205-298-65

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 23 matching rows.

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
b2a0b5c5-23e3-4445-9923-e35030139ae470d6039d-a379-410d-984a-9ff8cfa599c52025-04-09WarningsExact identifier
spl set id: 70d6039d-a379-410d-984a-9ff8cfa599c5

Reported adverse events (FAERS/openFDA)#

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