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Bisacodyl by Sunrise Pharmaceutical Inc

Medically reviewed on July 30, 2018

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: Sunrise Pharmaceutical Inc
NDC Code: 11534-156

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.

Bisacodyl USP 5 mg Laxative

OTC - ACTIVE INGREDIENT

Bisacodyl USP 5mg.

OTC - PURPOSE

Stimulant laxative.

INDICATIONS AND USAGE

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.

OTC - ASK DOCTOR

If you have

Stomach pain, nausea or vomiting

A sudden change in bowel habits that lasts for more than 2 weeks.

OTC - WHEN USING

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.

OTC - STOP USE

And ask a doctor if:

You have rectal bleeding or no bowel movement after using this product. These could be signs of serious condition.

You need to use laxative for more than 1 week

OTC - PREGNANCY OR BREAST FEEDING

Ask a health professional before use.

OTC - KEEP OUT OF REACH OF CHILDREN

In case of overdose, get medical help or contact a Poison Control Center right away.

DOSAGE AND ADMINISTRATION

Take with a glass of water

Adults and children 12 years and over1 to 3 tablets in a single daily dose
Children 6 to under 12 years1 tablet in a single daily dose
Children under 6 yearsAsk a doctor

OTHER INFORMATION

Store at 20(-25(C(68(-77(F). Protect from excessive humidity.

INACTIVE INGREDIENT

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 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BISACODYL 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-156
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 400 
POVIDONE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
POLYVINYL ACETATE PHTHALATE  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeTCL;003
Contains    
Packaging
#Item CodePackage Description
1NDC:11534-156-01100 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33407/08/2005
Labeler - Sunrise Pharmaceutical Inc (168522378)

 
Sunrise Pharmaceutical Inc

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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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