LAXATIVE ENTERIC COATED- bisacodyl 5mg tablet, sugar coated 
Allegiant Health

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Assured 44-327

Active ingredient (in each tablet)

Bisacodyl USP 5 mg

Purpose

Stimulant Laxative

Uses

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,

If pregnant or breast-feeding, ask a health professional before use.

Keep out of reach of children.

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

Adults and children 12 years of age and over: 1 to 3 tablets in a single daily dose

Children 6 to under 12 years of age: 1 tablet in a single daily dose

Children under 6 years of age: ask a doctor

Other information

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, propylparaben, propylene glycol, povidone, shellac glaze, simethicone, sodium alginate, sodium benzoate, sodium bicarbonate, stearic acid, sucrose, talc, titanium dioxide, triacetin, triethyl citrate

Principal display panel

Bisacodyl 5mg

Bisacodyl 5mg


LAXATIVE  ENTERIC COATED
bisacodyl 5mg tablet, sugar coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-404
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ACACIA (UNII: 5C5403N26O)  
AMMONIA (UNII: 5138Q19F1X)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C YELLOW NO. 10 (UNII: 35SW5USQ3G)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
FERROSOFERRIC OXIDE (UNII: XM0M87F357)  
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
POVIDONE (UNII: FZ989GH94E)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
SODIUM ALGINATE (UNII: C269C4G2ZQ)  
SODIUM BENZOATE (UNII: OJ245FE5EU)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SUCROSE (UNII: C151H8M554)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
DIMETHICONE (UNII: 92RU3N3Y1O)  
Product Characteristics
ColororangeScoreno score
ShapeROUNDSize6mm
FlavorImprint Code 5
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-404-921 in 1 CARTON03/25/2002
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
2NDC:69168-404-03250 in 1 BOTTLE; Type 0: Not a Combination Product03/25/2002
3NDC:69168-404-32100 in 1 BOTTLE; Type 0: Not a Combination Product05/18/2022
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00703/25/2002
Labeler - Allegiant Health (079501930)

Revised: 2/2019
Document Id: 755e478f-3c15-4175-9f32-45d2a751e282
Set id: 51f1c6c0-770c-4426-820b-bc1f42e143fd
Version: 4
Effective Time: 20190207
 
Allegiant Health