BISACODYL- bisacodyl tablet, coated 
Cardinal Health

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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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

card label

Principal Display Panel

Bisacodyl Tablets, USP

5 mg

QTY 30

lidding label
BISACODYL 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-3388(NDC:0904-7927)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
APIS MELLIFERA (UNII: 7S82P3R43Z)  
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
LACTOSE, UNSPECIFIED FORM (UNII: J2B2A4N98G)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
SHELLAC (UNII: 46N107B71O)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
SODIUM STARCH GLYCOLATE TYPE A POTATO (UNII: 5856J3G2A2)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-3388-930 in 1 BLISTER PACK; Type 0: Not a Combination Product06/02/201110/31/2013
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33406/02/201110/31/2013
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-3388)

Revised: 4/2018
 
Cardinal Health