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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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 age

take 1 to 3 tablets (usually 2) in a single daily dose

Children 6 years to under 12 years of age

take 1 tablet in a single daily dose

Children under 6 years of age

consult 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

bag label
BISACODYL 
bisacodyl tablet
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:55154-6705(NDC:0574-0004)
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)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
APIS MELLIFERA (UNII: 7S82P3R43Z)  
CALCIUM SULFATE, UNSPECIFIED FORM (UNII: WAT0DDB505)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
SHELLAC (UNII: 46N107B71O)  
POLYVINYL ACETATE PHTHALATE (UNII: 58QVG85GW3)  
POVIDONE, UNSPECIFIED (UNII: FZ989GH94E)  
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
ShapeROUNDSize5mm
FlavorImprint Code TLC;003
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:55154-6705-010 in 1 BAG06/02/201110/31/2011
11 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/02/201110/31/2011
Labeler - Cardinal Health (188557102)
Establishment
NameAddressID/FEIBusiness Operations
Cardinal Health188557102REPACK(55154-6705)

Revised: 4/2018
 
Cardinal Health