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Bisacodyl by Sunrise Pharmaceutical Inc

Dosage form: tablet, delayed release
Ingredients: BISACODYL 5mg
Labeler: Sunrise Pharmaceutical Inc
NDC Code: 11534-013

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

ACTIVE INGREDIENT

Bisacodyl USP 5mg.

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.

ASK DOCTOR BEFORE USE IF YOU HAVE

Stomach pain, nausea or vomiting

A sudden change in bowel habits that lasts for 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 serious condition.

You need to use laxative for more than 1 week

IF PREGNANT OR BREAST FEEDING

Ask a health professional before use.

DOSAGE AND ADMINISTRATION

Dosage and Administration text

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 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)

INACTIVE INGREDIENT

Calcium sulfate, carnuba wax, colloidal silicon dioxide, croscarmellose sodium, D & C yellow # 10, edible ink, FD & C yellow #6, gelatin, hydroxypropylymethyl cellulose, kaolin, lactose, magnesium stearate, methacrylic acid copolymer, microcrystalline celloluse, mineral oil, polyethylene glycol, propylene glycol, stearic acid, sucrose, sugar, talc, titanium dioxide, triethyl citrate.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
BISACODYL 
bisacodyl tablet, delayed release
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:11534-013
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM SULFATE 
CARNAUBA WAX 
SILICON DIOXIDE 
CROSCARMELLOSE SODIUM 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
HYPROMELLOSE 2910 (5 MPA.S) 
KAOLIN 
LACTOSE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
CELLULOSE, MICROCRYSTALLINE 
MINERAL OIL 
POLYETHYLENE GLYCOL 
PROPYLENE GLYCOL 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint CodeS1
Contains    
Packaging
#Item CodePackage Description
1NDC:11534-013-2525 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE
2NDC:11534-013-01100 TABLET, DELAYED RELEASE (TABLET) in 1 BOTTLE
3NDC:11534-013-031000 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

← See all Bisacodyl brands

Medically reviewed on Aug 9, 2018

Further information

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

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