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Bisacodyl by Pharbest Pharmaceuticals Inc.

Medically reviewed on June 11, 2018

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: Pharbest Pharmaceuticals Inc.
NDC Code: 16103-367

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.

Drug facts

Active ingredient (in each tablet)Bisacodyl 5 mg

Stimulant laxative

  • For temporary relief of occasional constipation and irregularity
  • This product generally produces bowel movement in 6 to 12 hours

Warnings

Do not useif 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.

DirectionsTake 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
  • Store at 20 - 250C (68-770F)
  • Protect from excessive humidity

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

BISACODYL 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:16103-367
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL ) BISACODYL 5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
ANHYDROUS LACTOSE 
YELLOW WAX 
CALCIUM SULFATE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
FERROSOFERRIC OXIDE 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
POLYVINYL ACETATE PHTHALATE 
POVIDONE K30 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeS1
Contains    
Packaging
#Item CodePackage Description
1NDC:16103-367-1725 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE, PLASTIC
2NDC:16103-367-08100 TABLET, DELAYED RELEASE (TABLET) 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/FEIOperations
Pharbest Pharmaceuticals Inc.557054835repack, relabel

 
Pharbest Pharmaceuticals Inc.

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Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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