BISACODYL- bisacodyl tablet
Cardinal Health

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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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, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C Yellow No. 10 lake, FD&C Yellow No. 6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearinc acid, sugar, talc, titanium dioxide.

Questions

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

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Bisacodyl Enteric Coated Tabs, USP 5mg

Enteric Coated Tablets

Delayed Release

10 Tablets

BISACODYL
bisacodyl tablet

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC:55154-0674(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
APIS MELLIFERA
CALCIUM SULFATE
CARNAUBA WAX
CELLULOSE, MICROCRYSTALLINE
STARCH, CORN
D&C YELLOW NO. 10
FD&C YELLOW NO. 6
GELATIN
LACTOSE
MAGNESIUM STEARATE
SHELLAC
POLYVINYL ACETATE PHTHALATE
SILICON DIOXIDE
SODIUM STARCH GLYCOLATE TYPE A POTATO
STEARIC ACID
SUCROSE
TALC
TITANIUM DIOXIDE

Product Characteristics
Color	ORANGE	Score	no score
Shape	ROUND	Size	5mm
Flavor		Imprint Code	5
Contains

Packaging
#	Item Code	Package Description
1	NDC:55154-0674-0	10 in 1 BAG
1		1 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		06/02/2011

Labeler - Cardinal Health (188557102)

Establishment
Name	Address	ID/FEI	Business Operations
Cardinal Health		188557102	REPACK(55154-0674)

Revised: 08/2012

Document Id: 9dbb680c-ec3c-4ec9-9a44-728363054c25

Set id: 0e55f510-8c43-4b3a-a6d3-c44d8169cb37

Version: 2

Effective Time: 20120809

Cardinal Health