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, 2024.

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 over	take 1 to 3 tablets in a single daily dose
Children 6 to under 12 years of age	take 1 tablet in a single daily dose
Children under 6 years	ask 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 Type	HUMAN OTC DRUG	Item Code (Source)	NDC:76457-003
Route of Administration	ORAL	DEA Schedule

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (DEACETYLBISACODYL)	BISACODYL	5 mg

Inactive Ingredients
Ingredient Name	Strength
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
Color	white (Clear)	Score	no score
Shape	CAPSULE (BiConvex)	Size	16mm
Flavor		Imprint Code	;
Contains

Packaging
#	Item Code	Package Description
1	NDC:76457-003-00	100 TABLET, COATED in 1 CARTON

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part334	02/09/2018

Labeler - Simpex Pharma Pvt. Ltd (916758275)

Establishment
Name	Address	ID/FEI	Operations
Simpex Pharma Pvt. Ltd		916758275	manufacture(76457-003)

Revised: 12/2018

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

SIMPEX Bisacodyl laxative

Further information

See also:

Rybelsus

Zepbound

Ozempic

Wegovy

Victoza

Saxenda

Alli

Methamphetamine

Amphetamine

Phentermine