SIMPEX BISACODYL LAXATIVE- bisacodyl tablet, coated 
Simpex Pharma Pvt. Ltd

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SIMPEX Bisacodyl laxative

Drug Facts


Active ingredient (in each tablet)

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Uses

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

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

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:

Label3

SIMPEX BISACODYL LAXATIVE 
bisacodyl tablet, coated
Product Information
Product TypeHUMAN OTC DRUGItem Code (Source)NDC:76457-003
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y) BISACODYL5 mg
Inactive Ingredients
Ingredient NameStrength
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
HYPROMELLOSE 2208 (15000 MPA.S) (UNII: Z78RG6M2N2)  
FERRIC OXIDE RED (UNII: 1K09F3G675)  
FERRIC OXIDE YELLOW (UNII: EX438O2MRT)  
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
METHACRYLIC ACID - ETHYL ACRYLATE COPOLYMER (1:1) TYPE A (UNII: NX76LV5T8J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
POLYETHYLENE GLYCOL 400 (UNII: B697894SGQ)  
POLYETHYLENE GLYCOL 600 (UNII: NL4J9F21N9)  
POVIDONE (UNII: FZ989GH94E)  
SODIUM BICARBONATE (UNII: 8MDF5V39QO)  
SODIUM LAURYL SULFATE (UNII: 368GB5141J)  
TALC (UNII: 7SEV7J4R1U)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
TRIETHYL CITRATE (UNII: 8Z96QXD6UM)  
Product Characteristics
Colorwhite (Clear) Scoreno score
ShapeCAPSULE (BiConvex) Size16mm
FlavorImprint Code ;
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:76457-003-00100 in 1 CARTON; Type 0: Not a Combination Product02/09/2018
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
OTC Monograph DrugM00702/09/2018
Labeler - Simpex Pharma Pvt. Ltd (916758275)
Establishment
NameAddressID/FEIBusiness Operations
Simpex Pharma Pvt. Ltd916758275manufacture(76457-003)

Revised: 11/2023
Document Id: 0b586450-2c14-70e7-e063-6394a90a5f33
Set id: 5114ed64-4fec-401b-8a91-8df3e42b10b1
Version: 7
Effective Time: 20231129
 
Simpex Pharma Pvt. Ltd