Active ingredient(s)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Use(s)

▪: for temporary relief of occasional constipation and irregularity
▪: this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing

Ask a doctor before use if you have

▪: stomach pain, nausea or vomiting
▪: a sudden change in bowel habits that lasts more than 2 weeks

When using this product

▪: do not chew or crush tablet(s)
▪: it may cause stomach discomfort, faintness or cramps
▪: do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

▪: you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
▪: you need to use a laxative for more than 1 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 right away.

Directions

take with a glass of water

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

Other information

▪: each tablet contains: sodium less than 0.5mg
▪: store at 20°-25°C (68°-77°F)
▪: protect from excessive humidity
▪: TAMPER EVIDENT: Blister packaged for your protection. Do not use if individual seals are broken

Inactive ingredients

acacia, anhydrous calcium sulfate, anhydrous lactose, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, gelatin, iron oxide, iron oxide black, iron oxide yellow, magnesium stearate, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

Questions

Call 1-800-200-6313, weekdays, 9am-4pm EST

Principal Display Panel

The product packaging shown below represents a sample of that currently in use. Additional packaging may also be available.

TABLETS

Leader Gentle Laxative

Overnight Relief of Constipation and Irregularity

*Compare to the active ingredient of Dulcolax®

LAXATIVE

Bisacodyl USP, 5 mg

25 Coated Tablets

CIN 2281715

Distributed By:

Cardinal Health

Dublin Ohio 43017

www.myleader.com

Leader Gentle Laxative

GENTLE LAXATIVE
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:37205-128
Route of Administration	ORAL

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

Ingredient Name	Strength
Inactive Ingredients
ACACIA (UNII: 5C5403N26O)
CALCIUM SULFATE ANHYDROUS (UNII: E934B3V59H)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
CARNAUBA WAX (UNII: R12CBM0EIZ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STARCH, CORN (UNII: O8232NY3SJ)
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)
FERROSOFERRIC OXIDE (UNII: XM0M87F357)
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)
MAGNESIUM STEARATE (UNII: 70097M6I30)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)
SHELLAC (UNII: 46N107B71O)
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)
STEARIC ACID (UNII: 4ELV7Z65AP)
SUCROSE (UNII: C151H8M554)
TALC (UNII: 7SEV7J4R1U)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	TCL;003
Contains

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:37205-128-63	1 in 1 CARTON	10/14/2011
1		25 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph not final	part334	10/14/2011

Labeler - Cardinal Health (097537435)