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Gentle Laxative by Cardinal Health

Medically reviewed on Feb 1, 2018

Dosage form: tablet
Ingredients: BISACODYL 5mg
Labeler: Cardinal Health
NDC Code: 37205-128

Disclaimer: Most OTC drugs are not reviewed and approved by FDA, however they may be marketed if they comply with applicable regulations and policies. FDA has not evaluated whether this product complies.

Leader Gentle Laxative

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 overtake 1 to 3 tablets in a single daily dose
 children 6 to under 12 years of agetake 1 tablet in a single daily dose
 children under 6 years of ageask 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 TypeHUMAN OTC DRUGItem Code (Source)NDC:37205-128
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
FERROSOFERRIC OXIDE 
FERRIC OXIDE YELLOW 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
POLYETHYLENE GLYCOL 
POLYVINYL ACETATE PHTHALATE 
POVIDONE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeTCL;003
Contains    
Packaging
#Item CodePackage Description
1NDC:37205-128-631 BLISTER PACK (BLISTER PACK) in 1 CARTON
125 TABLET (TABLET) in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/14/2011
Labeler - Cardinal Health (097537435)

 
Cardinal Health

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Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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