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Gentle Laxative by Cardinal Health

Medically reviewed on January 17, 2018

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Cardinal Health
NDC Code: 70000-0221

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 44-327

Active ingredient (in each tablet)

Bisacodyl 5 mg 

Purpose

Stimulant laxative 

Uses
  • this product generally produces bowel movement in 6 to 12 hours 
  • relieves occasional constipation and irregularity

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)
  • do not use within 1 hour after taking an antacid or milk
  • you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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
  • store at 25ºC (77ºF); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • see end flap for expiration date and lot number

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate 

Questions or comments?

1-800-426-9391

Principal Display Panel

NDC 70000-0221-1

LEADER™

Delayed-Release

Gentle Laxative
Bisacodyl, 5 mg | Stimulant Laxative

Gentle, Predictable
Overnight Relief

10 ENTERIC COATED
     TABLETS

COMPARE TO DULCOLAX® active ingredient*
100% Money Back Guarantee

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF BLISTER UNIT IS TORN, BROKEN OR SHOWS ANY SIGNS OF TAMPERING

*This product is not manufactured or distributed by Boehringer Ingelheim Pharmaceuticals, Inc., owner of the registered trademark Dulcolax® Laxative Tablets.

50844 ORG031232703

DISTRIBUTED BY
CARDINAL HEALTH
DUBLIN, OHIO 43017
www.myleader.com   1-800-200-6313
Essential to Care™ since 1979

Leader 44-327



GENTLE LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:70000-0221
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSES 
LACTOSE, UNSPECIFIED FORM 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOLS 
POVIDONE 
PROPYLENE 
Polyvinyl Acetate Phthalate 
PROPYLPARABEN 
SHELLAC 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:70000-0221-11 BLISTER PACK in 1 CARTON
110 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33403/25/2002
Labeler - Cardinal Health (097537435)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(70000-0221)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(70000-0221)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(70000-0221)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(70000-0221)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(70000-0221)

 
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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