Your browser does not support JavaScript! BISACODY ENTERIC COATED (BISACODYL) TABLET, COATED [TOP CARE (TOPCO ASSOCIATES LLC)]
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BISACODY ENTERIC COATED (bisacodyl) tablet, coated
[TOP CARE (Topco Associates LLC)]


Category DEA Schedule Marketing Status
HUMAN OTC DRUG LABEL OTC monograph not final
NOTE: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.
Drug Label Sections

Active ingredient (in each enteric coated tablet)

 Bisacodyl, USP 5 mg

Purpose

 Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces a bowel movement in 6 to 12 hours

Warnings

Do not use

if you cannot swallow without chewing.

Ask a doctor before use if you have

  • stomach pain, nausea or vomiting
  • a sudden change in bowel habits that lasts more than 2 weeks

When using this product

  • do not chew or crush tablet(s)
  • it may cause stomach discomfort, faintness or cramps
  • do not use within 1 hour after taking an antacid or milk

Stop use and ask a doctor if

  • you have rectal bleeding or no bowel movement after using this product. These could be signs of a serious condition.
  • you need to use a laxative for more than 1 week

If pregnancy or breast-feeding,

 ask a health professions before use.

Keep out of reach of children.

In case of overdose, get medical help or contact a Poison Control Center right away.

Directions

take with a glass of water
 adults and children 12 yers of age and over   take 1 to 3 tablets in a single daily dose 
 children 6 to under 12 years of age take 1 tablet in a single daily dose
 children under 6 years of age ask a doctor

Other information

  •  store at controlled room temperature 15º-30ºC (59º-86ºF)

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, polyethylene glycol (PEG) 400, polyvinyl acetate phthalate, povidone, shellac, sodium starch glycolate, stearic acid, sugar, talc, and titanium dioxide

Questions or comments?

 1-888-423-0139

Principal Display Panel

GENTLE, OVERNIGHT RELIEF

Laxative Tablets

Bisacodyl, USP 5 mg

  • Gentle, predictable, overnight relief from constipation

COMPARE TO DULCOLAX® active ingredient*

Enteric Coated Tablets

EACH TABLET IS INDIVIDUALLY SEALED IN A BLISTER PACK. DO NOT USE IF BLISTER FOIL IS BROKEN.

KEEP OUTER CARTON FOR COMPLETE WARNINGS AND PRODUCT INFORMATION.

*This product is not manufactured or distributed by Boehringer Ingelheim Consumer Health Care Products, owner of the registered trademark Dulcolax®

DISTRIBUTED BY TOPCO ASSOCIATES LLC

ELK GROVE VILLAGE, IL  60077

QUESTIONS? 1-888-423-0139

topcare@topco.com

Product Label

BISACODYL, USP 5 MG

TOP CARE BISACODYL LAXATIVE ORANGE ENTERIC COATED TABLET 25CT

 

BISACODY  ENTERIC COATED
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:36800-190
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (BISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM SULFATE ANHYDROUS 
ANHYDROUS LACTOSE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
GELATIN 
MAGNESIUM STEARATE 
CELLULOSE, MICROCRYSTALLINE 
SHELLAC 
SODIUM STARCH GLYCOLATE TYPE A POTATO 
STEARIC ACID 
TALC 
TITANIUM DIOXIDE 
Polyvinyl Acetate Phthalate 
SUCROSE 
POVIDONES 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
FERROSOFERRIC OXIDE 
POLYETHYLENE GLYCOLS 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code TCL003
Contains    
Packaging
#Item CodePackage Description
1NDC:36800-190-251 in 1 CARTON
125 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/10/2013
Labeler - TOP CARE (Topco Associates LLC) (006935977)
Registrant - P and L Development of New York Corporation (800014821)

Revised: 12/2012
Document Id: 9786f0da-7261-45eb-a01d-7fd51aba7a1c
Set id: ba92b18c-d8ca-42ae-b7fe-31b6df946432
Version: 1
Effective Time: 20121214
 
TOP CARE (Topco Associates LLC)

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