SIMPEX BISACODYL LAXATIVE- bisacodyl tablet, coated

SIMPEX Bisacodyl laxative by

Drug Labeling and Warnings

SIMPEX Bisacodyl laxative by is a Otc medication manufactured, distributed, or labeled by Simpex Pharma Pvt. Ltd. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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:

INGREDIENTS AND APPEARANCE

SIMPEX BISACODYL LAXATIVE 
bisacodyl tablet, coated

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 76457-003
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
BISACODYL (UNII: 10X0709Y6I) (DEACETYLBISACODYL - UNII:R09078E41Y)	BISACODYL	5 mg

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

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 76457-003-00	100 in 1 CARTON; Type 0: Not a Combination Product	02/09/2018

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	Business Operations
Simpex Pharma Pvt. Ltd		916758275	manufacture(76457-003)