DULCOLAX- bisacodyl tablet, coated 
Mechanical Servants, 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®

Drug Facts

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant laxative

Use

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)
  • do not use within 1 hour after taking an antacid or milk
  • it may cause stomach discomfort, faintness and cramps

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

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

Questions

1-888-285-9159 (English/Spanish)

Or visit www.DULCOLAX.com

Repackaged and distributed by Convenience Valet® Melrose Park, IL 60160

PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package

CONVENIENCE
CV
VALET®

DRINKING CUP
INCLUDED

Dulcolax®
LAXATIVE

(bisacodyl USP 5 mg)
C6A

3 TABLETS

PRINCIPAL DISPLAY PANEL - 5 mg Pouch Package
DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6741(NDC:0597-0012)
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bisacodyl (UNII: 10X0709Y6I) (bisacodyl - UNII:10X0709Y6I) bisacodyl5 mg
Inactive Ingredients
Ingredient NameStrength
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 glycols (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)  
diacetylated monoglycerides (UNII: 5Z17386USF)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code 12;BI
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:29485-6741-31 in 1 PACKAGE
13 in 1 POUCH
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33401/01/2010
Labeler - Mechanical Servants, Inc. (005530951)
Establishment
NameAddressID/FEIBusiness Operations
Boehringer Ingelheim Promeco S.A. de C.V.812579472MANUFACTURE
Establishment
NameAddressID/FEIBusiness Operations
Mechanical Servants, Inc.005530951RELABEL

Revised: 1/2012
Document Id: 92448d56-6df2-40f1-9d69-2f42999ae3c0
Set id: eac116c1-d109-4c01-8cd4-ba27ddd2ce40
Version: 1
Effective Time: 20120106
 
Mechanical Servants, Inc.