DULCOLAX - bisacodyl tablet, coated 
Physicians Total Care, 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 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 (bisacodyl USP) laxative tablets

5 mg

NDC 54868-0016-0

image of package label

DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0016(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 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
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint Code 12;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:54868-0016-01 in 1 CARTON
110 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33405/19/2010
Labeler - Physicians Total Care, Inc. (194123980)
Establishment
NameAddressID/FEIBusiness Operations
Physicians Total Care, Inc.194123980relabel

Revised: 11/2011
Document Id: 6dee501e-2e58-4ff2-901b-8f8693c776b7
Set id: 2913bcab-0cef-4796-9726-5906f4ec63f8
Version: 1
Effective Time: 20111104
 
Physicians Total Care, Inc.