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Dulcolax by Boehringer Ingelheim Pharmaceuticals, Inc.

Medically reviewed on May 9, 2018

Dosage form: tablet, coated
Ingredients: bisacodyl 5mg
Labeler: Boehringer Ingelheim Pharmaceuticals, Inc.
NDC Code: 0597-0012

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 ®
Bisacodyl (USP) 5 mg Tablets/Stimulant Laxative

Drug Facts

Active ingredient (in each tablet)Purpose
Bisacodyl (USP) 5 mgStimulant 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

  • it may cause stomach discomfort, faintness and cramps
  • do not chew or crush tablet(s)
  • 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 6 years of ageask a doctor

Other information

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

Inactive ingredients acacia gum, ammonium hydroxide, beeswax, carnauba wax, D&C Yellow #10 aluminum lake, D&C Red #30 aluminum lake, glycerin, glyceryl monostearate, iron oxide, lactose monohydrate, magnesium stearate, methacrylic acid ethyl acrylate copolymer, methyl paraben, modified corn starch, polyethylene glycol 6000, polysorbate 80, povidone, propyl paraben, shellac, sodium benzoate, sucrose, talc, titanium dioxide, triethyl citrate

Questions? call 1-888-285-9159 (English/Spanish), M – F, 8:30 – 5 EST, or visit www.Dulcolax.com

Distributed by: Boehringer Ingelheim (BI) Consumer Health Care Products Division of BI Pharmaceuticals, Inc., Ridgefield, CT 06877. Product of Italy. Manufactured in Mexico. © 2016, BI Pharmaceuticals, Inc. All rights reserved.

Dulcolax® 25 Tablets Carton

Dulcolax® 8 Tablets Carton

DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0012
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bisacodyl (bisacodyl) bisacodyl5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
AMMONIA 
YELLOW WAX 
CARNAUBA WAX 
D&C YELLOW NO. 10 
D&C RED NO. 30 
GLYCERIN 
GLYCERYL MONOSTEARATE 
FERRIC OXIDE RED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHYLPARABEN 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 80 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SODIUM BENZOATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
STARCH, CORN 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint CodeBI;12
Contains    
Packaging
#Item CodePackage Description
1NDC:0597-0012-261 BLISTER PACK in 1 CARTON
125 TABLET, COATED in 1 BLISTER PACK
2NDC:0597-0012-111 BLISTER PACK in 1 CARTON
210 TABLET, COATED in 1 BLISTER PACK
3NDC:0597-0012-586 BLISTER PACK in 1 CARTON
325 TABLET, COATED in 1 BLISTER PACK
4NDC:0597-0012-598 BLISTER PACK in 1 CARTON
425 TABLET, COATED in 1 BLISTER PACK
5NDC:0597-0012-502 BLISTER PACK in 1 CARTON
525 TABLET, COATED in 1 BLISTER PACK
6NDC:0597-0012-381 BLISTER PACK in 1 CARTON
68 TABLET, COATED in 1 BLISTER PACK
7NDC:0597-0012-004 BLISTER PACK in 1 CARTON
725 TABLET, COATED in 1 BLISTER PACK
8NDC:0597-0012-372 BLISTER PACK in 1 CARTON
815 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33410/01/2001
DULCOLAX 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0597-0340
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
bisacodyl (bisacodyl) bisacodyl5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
AMMONIA 
YELLOW WAX 
CARNAUBA WAX 
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) 
D&C YELLOW NO. 10 
D&C RED NO. 30 
GLYCERIN 
GLYCERYL MONOSTEARATE 
FERRIC OXIDE RED 
LACTOSE MONOHYDRATE 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
METHYLPARABEN 
POLYETHYLENE GLYCOL 6000 
POLYSORBATE 80 
POVIDONES 
PROPYLPARABEN 
SHELLAC 
SODIUM BENZOATE 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize5mm
FlavorImprint CodeBI;12
Contains    
Packaging
#Item CodePackage Description
1NDC:0597-0340-481 BLISTER PACK in 1 CARTON
125 TABLET, COATED in 1 BLISTER PACK
2NDC:0597-0340-711 BLISTER PACK in 1 CARTON
210 TABLET, COATED in 1 BLISTER PACK
3NDC:0597-0340-646 BLISTER PACK in 1 CARTON
325 TABLET, COATED in 1 BLISTER PACK
4NDC:0597-0340-978 BLISTER PACK in 1 CARTON
425 TABLET, COATED in 1 BLISTER PACK
5NDC:0597-0340-542 BLISTER PACK in 1 CARTON
525 TABLET, COATED in 1 BLISTER PACK
6NDC:0597-0340-821 BLISTER PACK in 1 CARTON
68 TABLET, COATED in 1 BLISTER PACK
7NDC:0597-0340-704 BLISTER PACK in 1 CARTON
725 TABLET, COATED in 1 BLISTER PACK
8NDC:0597-0340-722 BLISTER PACK in 1 CARTON
815 TABLET, COATED in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33408/01/2013
Labeler - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)
Registrant - Boehringer Ingelheim Pharmaceuticals, Inc. (603175944)

 
Boehringer Ingelheim Pharmaceuticals, 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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