Simpex Bisacodyl Laxative Tablet, Coated
FDA Label NDC 76457-003

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Simpex Pharma Pvt. Ltd for the product Simpex Bisacodyl Laxative (NDC 76457-003). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding drug facts, active ingredient (in each tablet), purpose, uses, do not use, when using this product, stop use and ask a doctor if, keep out of reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

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:

Label3 (Label3)

Label3 (Label3)

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