Simpex Bisacodyl Laxative

Simpex Bisacodyl Laxative
SPL v7
SPL
SPL Set ID 5114ed64-4fec-401b-8a91-8df3e42b10b1
Route
ORAL
Published
Effective Date 2018-02-09
Document Type 34390-5 HUMAN OTC DRUG LABEL

Drug Facts

Composition & Product

Active Ingredients
Deacetylbisacodyl (5 mg)
Inactive Ingredients
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

Identifiers & Packaging

Pill Appearance
Imprint: ; Shape: capsule Color: white Size: 16 mm Score: 1
Marketing Status
OTC MONOGRAPH DRUG Active Since 2018-02-09
Description

Bisacodyl 5 mg

Purpose

Stimulant Laxative

Medication Information

Purpose

Stimulant Laxative

Description

Bisacodyl 5 mg

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

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
Drug Facts



Other Information
  • preserve in well-closed containers at a temperature not exceeding 30°C 
  • avoid excessive humidity
Package Labeling:

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

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.

Active Ingredient (in Each Tablet)

Bisacodyl 5 mg

Structured Label Content

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

Stimulant Laxative

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

Do Not Use (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
Drug Facts



Other Information (Other information)
  • preserve in well-closed containers at a temperature not exceeding 30°C 
  • avoid excessive humidity
Package Labeling:

Inactive Ingredients (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

When Using This Product (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 (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. (keep out of reach of children.)

In case or overdose, get medical help orcontact a poison control center right away.

Active Ingredient (in Each Tablet) (Active ingredient (in each tablet))

Bisacodyl 5 mg

Advanced Ingredient Data

Raw Label Data

All Sections (JSON)

Additional Information

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Source: dailymed · Ingested: 2026-02-15T12:02:24.534154 · Updated: 2026-03-14T23:01:57.446196