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Bisacodyl by Cardinal Health

Dosage form: tablet
Ingredients: BISACODYL 5mg
Labeler: Cardinal Health
NDC Code: 55154-6705

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.

Bisacodyl Enteric-Coated 5 mg

Active ingredient

In each enteric coated tablet: Bisacodyl 5 mg

Purpose

Stimulant Laxative

Keep Out of Reach of Children

Keep out of the reach of children. In case of 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 health professional before use.

TAMPER EVIDENT: DO NOT USE IF A BLISTER UNIT IS TORN, BROKEN OR SHOW ANY SIGNS OF TAMPERING.

Do not chew tablets, do not give to children under 6 years, do not give to persons who cannot swallow without chewing, do not take within 1 hour after taking antacid or milk.

Ask a doctor before use if you have abdominal pain, nausea, vomiting or a sudden change in bowel movements that persist over a period of 2 weeks.

When using this product: do not use for a period longer than 1 week unless directed by a doctor; you may experience abdominal discomfort, faintness and cramps.

Stop use and ask a doctor if you have rectal bleeding or failure to have a bowel movement within 12 hours.

Directions

Do not chew or crush tablets

Adults and children over 12 years of agetake 1 to 3 tablets (usually 2) in a single daily dose
Children 6 years to under 12 years of agetake 1 tablet in a single daily dose
Children under 6 years of ageconsult a physician

Inactive ingredients

Acacia, anhydrous lactose, beeswax, calcium sulfate, carnauba wax, collodial silicon dioxide, corn starch, D&C yellow #10, FD&C yellow #6, gelatin, magnesium stearate, microcrystalline cellulose, pharmaceutical glaze, polyvinyl acetate phthalate, povidone, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide

Storage

Store at 20 to 25 C (68 to 77 F) [see USP for Controlled Room Temperature]

Use by expiration date on product.

Questions

Questions? 1 800 328 5113 Serious side effects associated with use of this product may be reported to this number.

Manufactured for:

Paddock Laboratories, INc

Minneapolis, MN 55427

Principal Display Panel

Bisacodyl 5mg Tablets

Enteric-Coated

Stimulant Laxative Tablets

10 Unit-Dose Tablets

BISACODYL 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6705(NDC:0574-0004)
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
ANHYDROUS LACTOSE 
APIS MELLIFERA 
CALCIUM SULFATE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
POLYVINYL ACETATE PHTHALATE 
POVIDONE 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint CodeTLC;003
Contains    
Packaging
#Item CodePackage Description
1NDC:55154-6705-010 BLISTER PACK (BLISTER PACK) in 1 BAG
11 TABLET (TABLET) in 1 BLISTER PACK
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

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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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