BISACODYL - bisacodyl tablet, delayed release 
Pharbest Pharmaceuticals Inc.

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.

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Drug facts

Active ingredient (in each tablet)

Bisacodyl 5 mg

Stimulant laxative

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

Other information

Inactive ingredients: acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, colloidal silicon dioxide, corn starch, D&C yellow #10 lake, edible ink, FD&C yellow #6 lake, gelatin, iron oxide black, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sugar, titanium dioxide


Questions?

Adverse drug event call: (866) 562-2756

Image of Package Label
BISACODYL 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-367
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (BISACODYL - UNII:10X0709Y6I) BISACODYL 5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
CALCIUM SULFATE (UNII: WAT0DDB505)  
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 (UNII: 2G86QN327L)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE K30 (UNII: U725QWY32X)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code S1
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:16103-367-1725 in 1 BOTTLE, PLASTIC
2NDC:16103-367-08100 in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33401/25/2006
Labeler - Pharbest Pharmaceuticals Inc. (557054835)
Establishment
NameAddressID/FEIBusiness Operations
Pharbest Pharmaceuticals Inc.557054835repack, relabel

Revised: 6/2012
Document Id: a86fbc38-1f71-4abc-aade-e98304763076
Set id: 29156c82-bb48-4356-860c-ca0e9001882e
Version: 1
Effective Time: 20120609
 
Pharbest Pharmaceuticals Inc.