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

In each tablet: Bisacodyl 5 mg

Purpose

Stimulant laxative

Keep Out of Reach of Children

Keep out of reach of children. In case of accidental overdose, get medical help or contact a Poison Control Center right away.

Uses

Relieves occasional constipation and irregularity. This product generally produces bowel movement in 6 to 12 hours

Warnings

This package is intended for institutional use only. If pregnant or breast-feeding, ask a doctor before use.

Do not use if you cannot swallow without chewing

Ask a doctor before use if you have stomach pain, nausea or vomiting or a sudden change in bowel habits that lasts over 2 weeks.

When using this product do not chew or crush tablet, do not use within 1 hour after taking an antacid or milk. When using this product 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. These may be signs of a serious condition. Stop use and ask a doctor if you need to use a laxative for more than 1 week.

Directions

adults and children 12 years and overtake 1 to 3 tablets (usually 2) in a single daily dose
children 6 to under 12 yearstake 1 tablet daily
children under 6 yearsask a doctor

Inactive ingredients

Acacia, bees wax, calcium sulfate, carnauba wax, cellulose, corn starch, D&C yellow #10 lake, FD&C yellow #6 lake, gelatin, lactose, magnesium stearate, pharmaceutical glaze, polyvinyl acetate phthalate, silica gel, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Storage

Store at to 20-25 C (68 to 77 F); excursions permitted to 15-30 C (59-86 F). [See USP Controlled Room Temperature].

Avoid excessive humidity.

Questions?

Adverse Drug Even Call: (800) 616-2471

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By LNK, Hauppauge, NY11788

Repackaged by Cardinal Health

Zanesville, OH 43701

Principal Display Panel

Bisacodyl 5 mg

Enteric Coated Tablets

Delayed Release

10 Tablets

bag and label

BISACODYL 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-0674(NDC:0904-7927)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
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
ColorORANGEScore no score
ShapeROUNDSize5mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMultilevel Packaging
1NDC:55154-0674-010 BLISTER PACK ( BLISTER PACK) in 1 BAGcontains a BLISTER PACK
11 TABLET ( TABLET) in 1 BLISTER PACKThis package is contained within the BAG (55154-0674-0)

Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/2011

Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK

Revised: 07/2011 Cardinal Health