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SIMPEX Bisacodyl laxative

Dosage form: tablet, coated
Ingredients: BISACODYL 5mg
Labeler: Simpex Pharma Pvt. Ltd
NDC code: 76457-003

Medically reviewed by Drugs.com. Last updated on Dec 11, 2023.

SIMPEX Bisacodyl laxative

Drug Facts


Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses
  • relives occasional constipation and irregularity
  • this product generally produces bowel movement in 6 to 12 hours

Warnings

Do not use
  • if you can not 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 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 or cramps

Stop use and ask a doctor if
  • you have rectal bleeding or fail to have a bowel movement after use 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 or overdose, get medical help orcontact a poison control center right away.

Directions
  • take with a glass of water.
Adults and children 12 years and overtake 1 to 3 tablets in a single daily dose
Children 6 to under 12 years of agetake 1 tablet in a single daily dose
Children under 6 yearsask a doctor

Other information
  • preserve in well-closed containers at a temperature not exceeding 30°C 
  • avoid excessive humidity

Inactive ingredients

anhydrous lactose, colloidal anhydrous silica, hypermellose, iron oxide red, iron oxide yellow, macrogol, magnesium stearate, methacrylic acid copolymer type C, microcrystalline cellulose, polyethylene glycol 400, polyethylene glycol 6000, povidone, sodium bicarbonate, sodiumlauryl sulfate, sodium starch glycolate type A, talc, titanium dioxide,triethyle citrate

Package Labeling:

SIMPEX BISACODYL LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-003
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (DEACETYLBISACODYL) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE 
SILICON DIOXIDE 
HYPROMELLOSE 2208 (15000 MPA.S) 
FERRIC OXIDE RED 
FERRIC OXIDE YELLOW 
POLYETHYLENE GLYCOL, UNSPECIFIED 
MAGNESIUM STEARATE 
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A 
MICROCRYSTALLINE CELLULOSE 
POLYETHYLENE GLYCOL 400 
POLYETHYLENE GLYCOL 600 
POVIDONE 
SODIUM BICARBONATE 
SODIUM LAURYL SULFATE 
TALC 
TITANIUM DIOXIDE 
TRIETHYL CITRATE 
Product Characteristics
Colorwhite (Clear) Scoreno score
ShapeCAPSULE (BiConvex) Size16mm
FlavorImprint Code;
Contains    
Packaging
#Item CodePackage Description
1NDC:76457-003-00100 TABLET, COATED in 1 CARTON
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC monograph not finalpart33402/09/2018
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIOperations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-003)

Document Id: 7d86fea4-e6fd-fa26-e053-2a91aa0a4e5f
Set id: 5114ed64-4fec-401b-8a91-8df3e42b10b1
Version: 6
Effective Time: 20181221
 
Simpex Pharma Pvt. Ltd

Further information

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

Medical Disclaimer