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Dulcolax by Physicians Total Care, Inc.

Medically reviewed on November 6, 2017

Dosage form: tablet, coated
Ingredients: bisacodyl 5mg
Labeler: Physicians Total Care, Inc.
NDC Code: 54868-0016

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
  • 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

Dulcolax (bisacodyl USP) laxative tablets

5 mg

NDC 54868-0016-0


DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:54868-0016(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 Code12;
Contains    
Packaging
#Item CodePackage Description
1NDC:54868-0016-01 BLISTER PACK (BLISTER PACK) in 1 CARTON
110 TABLET, COATED (TABLET) 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/FEIOperations
Physicians Total Care, Inc.194123980relabel

 
Physicians Total Care, Inc.

See Also

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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