LEADER WOMENS LAXATIVE- bisacodyl tablet, coated

LEADER WOMENS LAXATIVE by

Drug Labeling and Warnings

LEADER WOMENS LAXATIVE by is a Otc medication manufactured, distributed, or labeled by Cardinal Health. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Laxative

Uses

• ▪ for relief of occasional constipation and irregularity

Warnings

Ask a doctor before use if you have

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

When using this product

• ▪ 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

• ▪ 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,

ask a health professional before use.

Keep out of reach of children.

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

Directions

• 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

• ▪ 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

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?

1-800-719-9260

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

INGREDIENTS AND APPEARANCE

LEADER WOMENS LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 37205-298
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C RED NO. 7 (UNII: ECW0LZ41X8)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE RED (UNII: 1K09F3G675)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
KAOLIN (UNII: 24H4NWX5CO)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
RAW SUGAR (UNII: 8M707QY5GH)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	PINK (polished)	Score	no score
Shape	ROUND	Size	10mm
Flavor		Imprint Code	174
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 37205-298-65	2 in 1 CARTON	08/16/2019
1		15 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	08/16/2019

Labeler - Cardinal Health (097537435)