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Dulcolax by Mechanical Servants, Inc.

Dosage form: tablet, coated
Ingredients: bisacodyl 5mg
Labeler: Mechanical Servants, Inc.
NDC Code: 29485-6741

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®

Drug Facts

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

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)
  • 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
  • store at 20-25°C (68-77°F)
  • protect from excessive humidity

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

DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:29485-6741(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 glycols 
povidone 
propylparaben 
sodium benzoate 
sorbitan monooleate 
sucrose 
talc 
titanium dioxide 
white wax 
diacetylated monoglycerides 
FERRIC OXIDE RED 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code12;BI
Contains    
Packaging
#Item CodePackage Description
1NDC:29485-6741-31 POUCH (POUCH) in 1 PACKAGE
13 TABLET, COATED (TABLET) 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/FEIOperations
Boehringer Ingelheim Promeco S.A. de C.V.812579472MANUFACTURE
Establishment
NameAddressID/FEIOperations
Mechanical Servants, Inc.005530951RELABEL

Revised: 01/2012
 
Mechanical Servants, Inc.

See Also

Disclaimer: Every effort has been made to ensure that the information provided here is accurate, up-to-date and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. This information has been compiled for use by healthcare practitioners and consumers in the United States. The absence of a warning for a given drug or combination thereof in no way should be construed to indicate that the drug or combination is safe, effective or appropriate for any given patient. If you have questions about the substances you are taking, check with your doctor, nurse or pharmacist.

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