BISACODYL 5MG- bisacodyl 5mg tablet, coated 
Allegiant Health

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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232 - Health A2Z Womans Laxative

Active Ingredient (in each tablet)

Bisacodyl USP 5mg

Purpose

Stimulant Laxative

Uses

Warnings

Do not use

  • if you are unable to swallow without chewing
  • within 1 hour after taking an antacid or milk

Ask a doctor before use if you have

  • abdominal pain
  • nausea
  • vomiting
  • noticed a sudden change in bowel habits that persists over a period of 2 weeks

When using this product

  • do not chew or crush tablets
  • abdominal discomfort, faintness, and cramps may occur

Stop use and ask a doctor if

  • you need to use more than 1 week
  • rectal bleeding or failure to have a bowel movement after use of a laxative.

These may be signs of a serious condition.

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 accidental overdose, get medical help or contact a doctor or Poison Control Center (1-800-222-1222) right away.

Directions

Adults and children 12 years of age and older: take 1 to 3 tablets in a single dose, once daily

Children 6 to 12 years of age: take 1 tablet once a day

Children under 6 years of age: consult a doctor

Other information

Inactive ingredients

acacia, ammonium hydroxide, calcium carbonate, carnauba wax, colloidal anhydrous silica, corn starch, D&C red #27 aluminum lake, FD&C blue #2 aluminum lake, FD&C yellow # 6 aluminum lake, hypromellose, iron oxide black, lactose anhydrous, magnesium stearate, methylparaben, polyvinyl acetate pthalate, polydextrose, polyethylene glycol, 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 Pink

Bisacodyl 5mg Pink


BISACODYL 5MG 
bisacodyl 5mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-398
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)  
CALCIUM CARBONATE (UNII: H0G9379FGK)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STARCH, CORN (UNII: O8232NY3SJ)  
D&C RED NO. 27 (UNII: 2LRS185U6K)  
FD&C BLUE NO. 2--ALUMINUM LAKE (UNII: 4AQJ3LG584)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHYLPARABEN (UNII: A2I8C7HI9T)  
Polyvinyl Acetate Phthalate (UNII: 58QVG85GW3)  
POLYDEXTROSE (UNII: VH2XOU12IE)  
POLYETHYLENE GLYCOL 1000 (UNII: U076Q6Q621)  
PROPYLPARABEN (UNII: Z8IX2SC1OH)  
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
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)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize5mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-398-921 in 1 CARTON12/23/2014
125 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC MONOGRAPH NOT FINALpart33412/23/2014
Labeler - Allegiant Health (079501930)

Revised: 3/2019
Document Id: 05de2267-93b3-4b31-99ee-e7b7b9445f4e
Set id: 46a377f5-822b-496f-a73b-66d8f902680a
Version: 1
Effective Time: 20190326
 
Allegiant Health