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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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
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
1	NDC:0615-0598-39	30 in 1 BLISTER PACK

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	Business Operations
NCS HealthCare of KY, Inc dba Vangard Labs		050052943	RELABEL, REPACK

Revised: 06/2011

Document Id: 99e99328-d509-481f-9715-5a42dae73529

Set id: 6d2f1549-a692-4a37-b13f-64f858232967

Version: 1

Effective Time: 20110614

NCS HealthCare of KY, Inc dba Vangard Labs