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, calcium sulfate anhydrous, carnauba wax, corn starch, D&C red #7 calcium lake, hypromellose phthalate, iron oxide black, iron oxide red, iron oxide yellow, kaolin, magnesium stearate, microcrystalline cellulose, polyethylene glycol 400, povidone, shellac, silicon dioxide, sodium starch glycolate, stearic acid, sugar, talc, titanium dioxide, triacetin

Principal Display Panel

HealthA2Z®

Compare to Correctol® active ingredient*

Woman's Gentle 

Laxative

BISACODYL STIMULANT LAXATIVE 5mg

For Gentle, Reliable 

Overnight Relief

(double pill image)

Tablets

Woman's Laxative 30ct. Tablets

Woman's Laxative 30ct. Tablets

BISACODYL 5MG 
bisacodyl 5mg tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:69168-232
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 SULFATE ANHYDROUS (UNII: E934B3V59H)  
CARNAUBA WAX (UNII: R12CBM0EIZ)  
STARCH, CORN (UNII: O8232NY3SJ)  
KAOLIN (UNII: 24H4NWX5CO)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POVIDONE (UNII: FZ989GH94E)  
SHELLAC (UNII: 46N107B71O)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIACETIN (UNII: XHX3C3X673)  
Product Characteristics
ColorPINKScoreno score
ShapeROUNDSize5mm
FlavorImprint Code TCL;057
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:69168-232-852 in 1 CARTON12/23/2014
115 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: 11/2017
Document Id: 860edd21-09bd-494f-a3bb-58fad750c9e5
Set id: 2d8defb6-280a-4e63-a54a-19fd90fe5498
Version: 3
Effective Time: 20171116
 
Allegiant Health