Your browser does not support JavaScript! DULCOLAX (BISACODYL) TABLET, COATED [BOEHRINGER INGELHEIM PHARMACEUTICALS INC.]
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RxNorm Names

DULCOLAX (bisacodyl) tablet, coated
[Boehringer Ingelheim Pharmaceuticals Inc.]


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

Drug Facts 
Active ingredient (in each tablet)Purpose
Bisacodyl USP 5 mg .................................................................................Stimulant laxative

Use

  • for temporary relief of occasional constipation and irregularity
  • this product generally produces 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 and 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 pregnant or breast-feeding, ask a health professional 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 years and over1 to 3 tablets in a single daily dose
children 6 to under 12 years of age1 tablet in a single daily dose
children under 6 years of ageask a doctor

Other information

  • store at controlled room temperature 15°-30°C (59°- 86°F)
  • avoid excessive humidity

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, corn starch, D&C Red # 27 aluminum lake, FD&C Blue # 2 aluminum lake, FD&C Yellow #6 aluminum lake, hypromellose, iron oxide black, lactose, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac, silica, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions?

Call toll-free 1-888-285-9159 (English/Spanish) Or visit www.DULCOLAX.com

Dulcolax For Women
Bisacodyl 5mg
NDC: 0597-0150-26

Dulcolax for Women Carton
DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0597-0150
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bisacodyl (bisacodyl) bisacodyl5 mg
Inactive Ingredients
Ingredient NameStrength
acacia 
ammonia 
calcium carbonate 
carnauba wax 
starch, corn 
D&C Red NO. 27 
aluminum oxide 
FD&C Blue NO. 2 
FD&C Yellow NO. 6 
hypromelloses 
ferrosoferric oxide 
lactose 
magnesium stearate 
methylparaben 
polydextrose 
polyethylene glycols 
polyvinyl acetate phthalate 
povidone 
propylene glycol 
propylparaben 
shellac 
silicon dioxide 
sodium alginate 
sodium benzoate 
sodium bicarbonate 
stearic acid 
sucrose 
talc 
titanium dioxide 
triacetin 
triethyl citrate 
Product Characteristics
ColorPINKScoreno score
ShapeROUND (Round) Size6mm
FlavorImprint Code DW
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0150-261 in 1 CARTON
125 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/23/2012
Labeler - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
LNK International, Inc.038154464MANUFACTURE(0597-0150)

Revised: 3/2012
 
Boehringer Ingelheim Pharmaceuticals Inc.

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