Bisacodyl

BISACODYL ORAL HUMAN OTC DRUG

Bisacodyl is an FDA drug label for the active ingredient BISACODYL manufactured by KROGER COMPANY 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 20260909.

Generic name
BISACODYL
Manufacturer
KROGER COMPANY
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
41226-003
Application
M007
Label effective
20260909

About this product

Bisacodyl is an FDA-registered drug product whose active ingredient is BISACODYL. It is labelled by KROGER COMPANY taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 41226-003, application M007, label effective 20260909. It is one of 38 FDA drug label records sharing the active ingredient BISACODYL. This page reproduces the FDA-approved label text so you can check what a product is, who makes it and how it is supplied before discussing it with a pharmacist or prescriber.

What it is used for

Across FDA labelling, products containing BISACODYL are most often described in connection with: relieves occasional, product generally, produces bowel, movement hours. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active ingredeint (in each tablet) Bisacodyl 5 mg

Indications & Usage

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

Dosage & Administration

Directions take with a glass of water adults and children 12 years of age and over Start with 1 tablet/day. If needed, increase to 2 or 3 tablets a day in a single daily dose children 6 to under 12 years of age 1 tablet per day children under 6 years of age ask a doctor

Warnings

Warnings

More products with the same ingredient

BISACODYL

BISACODYL

AARNA USA INC. View label

Bisacodyl Laxative

Geiss, Destin & Dunn Inc. View label

Bisacodyl Laxative

InvaDerm Corporation View label

Bisacodyl Stimulant Laxative

Raritan Pharmaceuticals Inc View label

Gentle Laxative

Walgreen Company View label

How products containing BISACODYL compare

FDA lists 38 drug label records with BISACODYL as the active ingredient. The most common dosage forms and the manufacturers with the most records are summarised below; strengths, pack sizes and inactive ingredients can still differ between apparently similar products.

Dosage formProductsManufacturerProducts
— — Chain Drug Marketing Association, Inc. 2
— — Family Dollar Services Inc 2
— — Geiss, Destin & Dunn Inc. 2
— — HHH Pharmaceuticals 2
— — Publix Super Markets Inc 2

Recall and safety notices

5 FDA recall record(s) match this product name or manufacturer. A match means the firm or product name appears in the enforcement report; confirm lot numbers and dates against the official FDA notice before acting.

RecallProductFirmClassStatusReported
D-1425-2022 QP LAXATIVE BISACODYL 5 MG TABLET 50 CT SKU 902449 QP WOMEN LAXATIVE BISCODYL TABLET 25 CT SKU 915221 distributed to specific Family Dollar Stores 04/30/2022 through 06/10/2022. Family Dollar Stores, Llc. Class II Ongoing 20220831
D-1312-2022 Bisacodyl Suppositories, Fast Acting Stimulant Laxative, 100 suppositories per box, 10 mg each, Health Star, NDC 57896-443-01. Mckesson Medical-Surgical Inc. Corporate Office Class II Terminated 20220817
D-1385-2019 Bisacodyl Suppositories, Brite Stock, Reese. Torrent Pharma Inc Class II Terminated 20190619
D-1357-2019 Biscolax Laxative (Bisacodyl, USP 10 mg), a) 12 suppositories per carton, NDC: 0904-5058-12, b) 100 suppositories per carton, NDC: 0904-5058-60, Distributed by Major Pharmaceuticals Inc., Livonia MI 48152. Torrent Pharma Inc Class II Terminated 20190619
D-1377-2019 Laxative Suppositories (Bisacodyl USP, 10 mg), a) 12 Suppositories per carton, NDC: 0536-1355-12, b) 100 Suppositories per carton, NDC: 0536-1355-01, Distributed Rugby Laboratories, Livonia, MI 48152. Torrent Pharma Inc Class II Terminated 20190619

Frequently asked questions

What is Bisacodyl used for?
Uses relieves occasional constipation and irregularity this product generally produces a bowel movement in 6 to 12 hours

Who makes Bisacodyl?
KROGER COMPANY is the labeler of record for Bisacodyl. 38 FDA label records share the active ingredient BISACODYL, so generic and branded versions may come from different companies; the manufacturer named on your pack is the one that matters for any enquiry.

What form does Bisacodyl come in?
administered by oral. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Bisacodyl prescription or over-the-counter?
The FDA label for this product is recorded as human otc drug. Marketing status can differ between strengths and countries, so check the dispensing rules where you live.

Are there other products containing BISACODYL?
Yes. 38 FDA drug label records list BISACODYL as the active ingredient. Products with the same active ingredient can usually be substituted only when a prescriber or pharmacist confirms it is appropriate.

Has Bisacodyl been recalled?
5 FDA recall record(s) match this product name or manufacturer. Review the recall and safety notices section on this page and confirm lot numbers against the official FDA enforcement report.

Where does this information come from?
All content is reproduced from FDA Structured Product Labelling data via openFDA. It is provided for identification and reference only and is not medical advice.

This page reproduces FDA Structured Product Labelling data for identification and reference. It is not medical advice, does not diagnose or treat any condition, and does not sell or price any medicine.