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Bisacodyl

Medically reviewed by Drugs.com. Last updated on March 4, 2020.

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Major Pharmaceuticals
NDC Code: 0904-6748

Further information

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

Major 44-327

Active ingredient (in each tablet)

Bisacodyl USP, 5 mg

Purpose

Stimulant laxative

Uses
  • for 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
  • you may have stomach discomfort, faintness and cramps

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use of a laxative. 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 (1-800-222-1222) right away.

Directions
  • take with a glass of water
adults and children
12 years and over
take 1 to 3 tablets
in a single daily dose 
children 6 to under
12 years
take 1 tablet in a single
daily dose
children under 6 yearsask a doctor

Other information
  • store at 25°C (77°F); excursions permitted between 15°-30°C (59°-86°F)
  • avoid excessive humidity
  • use by expiration date on package

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C yellow #10 aluminum lake, FD&C yellow #6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polydextrose, polyethylene glycol, polyvinyl acetate phthalate, povidone, propylene glycol, propylparaben, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Questions or comments?

(800)-616-2471

Principal display panel

Major®

NDC 0904-6748-60

Bisacodyl
USP, 5 mg TABLETS

Stimulant Laxative

For Temporary Relief of
Occasional Constipation

ENTERIC COATED

Compare to the active ingredient
in DULCOLAX® Laxative Tablets*

Actual Size

100 TABLETS

TAMPER EVIDENT: DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

*This product is not manufactured pr distributed by
Sanofi-Aventis Deutschland GMBH, owner of the
registered trademark Dulcolax® Laxative Tablets.

50844    REV0119A32712

Distributed by MAJOR® PHARMACEUTICALS
17177 N Laurel Park Drive, Suite 233
Livonia, MI 48152 USA     M-17
Rev. 03/19   Re-order No. 700929

Major 44-327

BISACODYL 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:0904-6748
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA 
CALCIUM CARBONATE 
CARNAUBA WAX 
SILICON DIOXIDE 
STARCH, CORN 
D&C YELLOW NO. 10 
FD&C YELLOW NO. 6 
HYPROMELLOSE, UNSPECIFIED 
FERROSOFERRIC OXIDE 
ANHYDROUS LACTOSE 
MAGNESIUM STEARATE 
METHYLPARABEN 
POLYDEXTROSE 
POLYETHYLENE GLYCOL, UNSPECIFIED 
Polyvinyl Acetate Phthalate 
POVIDONE 
PROPYLENE GLYCOL 
PROPYLPARABEN 
SHELLAC 
DIMETHICONE 
WATER 
SODIUM ALGINATE 
SODIUM BENZOATE 
SODIUM BICARBONATE 
STEARIC ACID 
SUCROSE 
TALC 
TITANIUM DIOXIDE 
TRIACETIN 
TRIETHYL CITRATE 
AMMONIA 
Product Characteristics
ColorORANGEScoreno score
ShapeROUNDSize6mm
FlavorImprint Code5
Contains    
Packaging
#Item CodePackage Description
1NDC:0904-6748-171 BLISTER PACK in 1 CARTON
125 TABLET, COATED in 1 BLISTER PACK
2NDC:0904-6748-60100 TABLET, COATED in 1 BOTTLE, PLASTIC
3NDC:0904-6748-801000 TABLET, COATED in 1 BOTTLE, PLASTIC
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/01/2018
Labeler - Major Pharmaceuticals (191427277)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867894MANUFACTURE(0904-6748)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.832867837PACK(0904-6748)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.967626305PACK(0904-6748)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.038154464PACK(0904-6748)
Establishment
NameAddressID/FEIOperations
LNK International, Inc.868734088PACK(0904-6748)

 
Major Pharmaceuticals