SIMPEX Bisacodyl laxative

SIMPEX Bisacodyl laxative is an FDA drug label for the active ingredient BISACODYL manufactured by Simpex Pharma Pvt. Ltd administered by ORAL. This page reproduces the FDA-approved indications and usage, dosage, contraindications, warnings, and adverse reactions exactly as published in the drug label. Data source: openFDA (U.S. FDA), label effective 20231129.

Generic: BISACODYL

Manufacturer: Simpex Pharma Pvt. Ltd

Product Type: HUMAN OTC DRUG

Route: ORAL

Dosage Form:

NDC: 76457-003

Application: M007

Effective: 20231129

Active Ingredients: Active ingredient (in each tablet) Bisacodyl 5 mg Purpose Stimulant Laxative

Indications & Usage

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

Dosage & Administration

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

Contraindications

Not available.

Warnings

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.

Adverse Reactions

Not available.

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