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Name:Bisacodyl Enteric Coated
Manufacturer:Ncs Healthcare Of Ky, Inc Dba Vangard Labs
Category:Over-the-counter (OTC) Marketed Drugs


Bisacodyl Enteric Coated Tablet

BISACODYL ENTERIC COATED - bisacodyl tablet, coated 
NCS HealthCare of KY, Inc dba Vangard Labs

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 Enteric Coated Tablet

Active ingredient(s)

 Bisacodyl 5mg

Purpose

 Stimulant laxative

Use(s)

 -relieves occasional constipation and irregularity

 -this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use

 Do not use if you cannot swallow without chewing

Ask a doctor before use if

 -you have a sudden change in bowel habits that lasts more than 2 weeks

-stomach pain, nausea or vomiting

When using this product

 -do not use within 1 hour after taking an antacid or milk

-do not chew or crush tablet(s)

-you may have stomach discomfort, faintness or cramps

Stop use and ask a doctor if

 -you have rectal bleeding or fail to have a bowel movement after use of a laxative. These could be signs of a serious condition.

-you need to use a laxative for more than 1 week

Pregnancy/Breastfeeding

 ask a health professions before use.

Keep out of reach of children

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 over- take 1 to 3 tablets in a single daily dose

children 6 to under 12 years of age - take 1 tablet in a single daily dose

children under 6 years of age - ask a doctor

Other information

 -store at 25 degrees C (77 degrees F) excursions permitted between 15 degrees-30 degrees C (59 degrees-86 degrees F)

-use by expiration date on package

-protect from excessive humidity

Storage

Inactive ingredients

 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 (iron oxice ochre), magnesium stearat, microcrystalline cellulose, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate povidone, shellac, sodium starch glycolate stearic acie, sugar, talc, titanium dioxide.

Questions

 To Report Adverse Drug Event call: (800) 616-2471

Principal Display Panel

 Bisacodyl Enteric Coated Tabs, USP 5mg

Bisacodyl Enteric Coated Tabs, USP 5mg


BISACODYL ENTERIC COATED 
bisacodyl enteric coated tablet, coated
Product Information
Product Type HUMAN OTC DRUG Item Code (Source) NDC:0615-0598(NDC:0904-7927)
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 ANHYDROUS  
ANHYDROUS LACTOSE  
CARNAUBA WAX  
COLLOIDAL SILICON DIOXIDE  
STARCH, CORN  
D&C YELLOW NO. 10  
FD&C YELLOW NO. 6  
GELATIN  
MAGNESIUM STEARATE  
CELLULOSE, MICROCRYSTALLINE  
AMMONIUM NONOXYNOL-4 SULFATE  
Polyvinyl Acetate Phthalate  
POVIDONE  
SHELLAC  
SODIUM STARCH GLYCOLATE TYPE A POTATO  
STEARIC ACID  
TALC  
TITANIUM DIOXIDE  
FERRIC OXIDE  
FERRIC OXIDE BLACK  
FERRIC OXIDE YELLOW  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 6mm
Flavor Imprint Code LNK;M
Contains     
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:0615-0598-39 30 TABLET, COATED (30 TABLET) in 1 BLISTER PACK None

Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC MONOGRAPH NOT FINAL part334 09/02/1993

Labeler - NCS HealthCare of KY, Inc dba Vangard Labs (050052943)
Establishment
Name Address ID/FEI Operations
NCS HealthCare of KY, Inc dba Vangard Labs 050052943 RELABEL, REPACK

Revised: 06/2011 NCS HealthCare of KY, Inc dba Vangard Labs



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


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