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Bisacodyl

Dosage form: tablet
Ingredients: BISACODYL 5mg
Labeler: Cardinal Health
NDC Code: 55154-3388

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.

Bisacodyl Enteric Coated 5 mg

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(s), 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 of a laxative. 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.

If pregnant or breast-feeding, ask a health professional before use.

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

take 1 tablet in a single daily dose

children under 6 years

ask a doctor

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 oxide ochre), magnesium stearate, microcrystalline cellulose, ployethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Storage

Store at 25 C (77 F); excursions permitted to 15-30 C (59-86 F).

Protect from excessive humidity.

Questions?

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

Distributed by

MAJOR PHARMACEUTICALS

31778 Enterprise Drive

Livonia, MI 48150 USA

MFGD By LNK, Hauppauge, NY11788

Cardinal Health

Zanesville, OH 43701

IT48468120313

Rev. 9/10

Principal Display Panel

Bisacodyl Tablets, USP

5 mg

Principal Display Panel

Bisacodyl Tablets, USP

5 mg

QTY 30

BISACODYL 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3388(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
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint CodeTCL;003
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-3388-930 TABLET in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/02/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIOperations
Cardinal Health188557102REPACK(55154-3388)

Revised: 03/2015
 
Cardinal Health

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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