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Name:Bisacodyl
Manufacturer:Sunrise Pharmaceutical Inc
Category:Over-the-counter (OTC) Marketed Drugs


Bisacodyl USP 5 mg Laxative

BISACODYL  - bisacodyl tablet, delayed release 
Sunrise Pharmaceutical 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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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 over 1 to 3 tablets in a single daily dose
Children 6 to under 12 years 1 tablet in a single daily dose
Children under 6 years Ask 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

f8e01e27-figure-01

BISACODYL 
bisacodyl tablet, delayed release
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:11534-156
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
BISACODYL (BISACODYL) BISACODYL 5 mg
Inactive Ingredients
Ingredient Name Strength
ACACIA  
CALCIUM SULFATE  
LACTOSE  
CARNAUBA WAX  
SILICON DIOXIDE  
STARCH, CORN  
CROSCARMELLOSE SODIUM  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
GELATIN  
FERROSOFERRIC OXIDE  
FERRIC OXIDE RED  
FERRIC OXIDE YELLOW  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
POLYETHYLENE GLYCOL  
POVIDONE  
POVIDONE  
SHELLAC  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
SUCROSE  
TALC  
TITANIUM DIOXIDE  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code TCL;003
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:11534-156-01 100 TABLET, DELAYED RELEASE ( TABLET) in 1 BOTTLE None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 07/08/2005

Labeler - Sunrise Pharmaceutical Inc (168522378)

Revised: 06/2010 Sunrise Pharmaceutical Inc



Source: http://dailymed.nlm.nih.gov
Reproduced with permission of U.S. National Library of Medicine


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