DULCOLAX- bisacodyl tablet, coated 
Boehringer Ingelheim Pharmaceuticals, Inc.

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.

----------

Dulcolax ® Tablets

Drug Facts

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

Uses

  • 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 of age 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 2 years of ageask a doctor

Other information

Inactive ingredients

acacia, acetylated monoglyceride, carnauba wax, cellulose acetate phthalate, corn starch, dibutyl phthalate, docusate sodium, gelatin, glycerin, iron oxides, kaolin, lactose, magnesium stearate, methylparaben, pharmaceutical glaze, polyethylene glycol, povidone, propylparaben, Red No. 30 lake, sodium benzoate, sorbitan monooleate, sucrose, talc, titanium dioxide, white wax, Yellow No. 10 lake

Dulcolax Tablets
DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUG LABELItem Code (Source)NDC:0597-0012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bisacodyl (bisacodyl) bisacodyl5 mg
Inactive Ingredients
Ingredient NameStrength
acacia 
carnauba wax 
cellacefate 
starch, corn 
dibutyl phthalate 
docusate sodium 
gelatin 
glycerin 
kaolin 
lactose 
magnesium stearate 
methylparaben 
shellac 
polyethylene glycol 
povidone 
propylparaben 
sodium benzoate 
sorbitan monooleate 
sucrose 
talc 
titanium dioxide 
white wax 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code 12;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0597-0012-004 in 1 CARTON
125 in 1 BLISTER PACK
2NDC:0597-0012-111 in 1 CARTON
210 in 1 BLISTER PACK
3NDC:0597-0012-261 in 1 CARTON
325 in 1 BLISTER PACK
4NDC:0597-0012-331 in 1 CARTON
43 in 1 POUCH
5NDC:0597-0012-344 in 1 BLISTER PACK
6NDC:0597-0012-373 in 1 CARTON
610 in 1 BLISTER PACK
7NDC:0597-0012-381 in 1 CARTON
78 in 1 BLISTER PACK
8NDC:0597-0012-502 in 1 CARTON
825 in 1 BLISTER PACK
9NDC:0597-0012-586 in 1 CARTON
925 in 1 BLISTER PACK
10NDC:0597-0012-598 in 1 CARTON
1025 in 1 BLISTER PACK
11NDC:0597-0012-7950 in 1 CARTON
113 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2001
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
NameAddressID/FEIBusiness Operations
Boehringer Ingelheim Promeco S.A. de C.V.812579472MANUFACTURE

Revised: 11/2010
Document Id: 8527ae95-fdfd-4b62-9f56-598c2656aeb6
Set id: 8527ae95-fdfd-4b62-9f56-598c2656aeb6
Version: 1
Effective Time: 20101101
 
Boehringer Ingelheim Pharmaceuticals, Inc.