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.

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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 over 1 to 3 tablets in a single daily dose
children 6 to under 12 years of age 1 tablet in a single daily dose
children under 2 years of age ask 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 Type HUMAN OTC DRUG Item Code (Source) NDC:0597-0012
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl 5 mg
Inactive Ingredients
Ingredient Name Strength
acacia (UNII: 5C5403N26O)  
carnauba wax (UNII: R12CBM0EIZ)  
cellacefate (UNII: F2O5O2OI9F)  
starch, corn (UNII: O8232NY3SJ)  
dibutyl phthalate (UNII: 2286E5R2KE)  
docusate sodium (UNII: F05Q2T2JA0)  
gelatin (UNII: 2G86QN327L)  
glycerin (UNII: PDC6A3C0OX)  
kaolin (UNII: 24H4NWX5CO)  
lactose (UNII: J2B2A4N98G)  
magnesium stearate (UNII: 70097M6I30)  
methylparaben (UNII: A2I8C7HI9T)  
shellac (UNII: 46N107B71O)  
polyethylene glycol (UNII: 3WJQ0SDW1A)  
povidone (UNII: FZ989GH94E)  
propylparaben (UNII: Z8IX2SC1OH)  
sodium benzoate (UNII: OJ245FE5EU)  
sorbitan monooleate (UNII: 06XEA2VD56)  
sucrose (UNII: C151H8M554)  
talc (UNII: 7SEV7J4R1U)  
titanium dioxide (UNII: 15FIX9V2JP)  
white wax (UNII: 7G1J5DA97F)  
Product Characteristics
Color ORANGE Score no score
Shape ROUND Size 5mm
Flavor Imprint Code 12;
Contains     
Packaging
# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:0597-0012-00 4 in 1 CARTON
1 25 in 1 BLISTER PACK
2 NDC:0597-0012-11 1 in 1 CARTON
2 10 in 1 BLISTER PACK
3 NDC:0597-0012-26 1 in 1 CARTON
3 25 in 1 BLISTER PACK
4 NDC:0597-0012-33 1 in 1 CARTON
4 3 in 1 POUCH
5 NDC:0597-0012-34 4 in 1 BLISTER PACK
6 NDC:0597-0012-37 3 in 1 CARTON
6 10 in 1 BLISTER PACK
7 NDC:0597-0012-38 1 in 1 CARTON
7 8 in 1 BLISTER PACK
8 NDC:0597-0012-50 2 in 1 CARTON
8 25 in 1 BLISTER PACK
9 NDC:0597-0012-58 6 in 1 CARTON
9 25 in 1 BLISTER PACK
10 NDC:0597-0012-59 8 in 1 CARTON
10 25 in 1 BLISTER PACK
11 NDC:0597-0012-79 50 in 1 CARTON
11 3 in 1 POUCH
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
OTC monograph not final part334 10/01/2001
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Establishment
Name Address ID/FEI Business Operations
Boehringer Ingelheim Promeco S.A. de C.V. 812579472 MANUFACTURE

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.