Bisacodyl Laxative

BISACODYL RECTAL HUMAN OTC DRUG

Bisacodyl Laxative is an FDA drug label for the active ingredient BISACODYL manufactured by InvaDerm Corporation administered by RECTAL. 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 20260810.

Generic name
BISACODYL
Manufacturer
InvaDerm Corporation
Product type
HUMAN OTC DRUG
Route
RECTAL
Dosage form
N/A
NDC
71457-501
Application
M007
Label effective
20260810

About this product

Bisacodyl Laxative is an FDA-registered drug product whose active ingredient is BISACODYL. It is labelled by InvaDerm Corporation taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 71457-501, application M007, label effective 20260810. 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: relief occasional, product generally, produces bowel, movement hour. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Active ingredients

Active i ngredient (in each suppository) Bisacodyl (USP) 10 mg

Indications & Usage

Use for relief of occasional constipation and irregularity this product generally produces bowel movement in 1/4 to 1 hour

Dosage & Administration

Directions detach 1 suppository from the strip; remove wrapper before inserting into the rectum as follows: hold suppository with pointed end up carefully separate tabs with fingernail slowly pull apart by pulling tabs down on both side remove suppository from wrapper (see illustration at the right) gently remove the suppository from the wrapper lie on your side and push suppository, pointed end first, high into the rectum so it will not slip out retain it for 15 to 20 minutes Do not exceed recommended dose if suppository seems soft, place in refrigerator for short time before use Adults and children 12 years and over 1 suppository once daily Children under 12 years Ask a doctor directions

Warnings

Warnings For rectal use only. Do not use laxative products when abdominal pain, nausea, or vomiting are present for a period longer than 1 week Ask a doctor before use if you have noticed a sudden change in bowel habits that lasts more than 2 weeks When using this product it may cause abdominal discomfort, faintness, rectal burning and mild cramps Stop use and ask a doctor if you have rectal bleeding or fail you fail to have a bowel movement after using a laxative. These could be signs of a serious condition. you need to use a laxative for more than one week If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children. If swallowed, get medical help or contact a Poison Control Center right away.

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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

Frequently asked questions

What is Bisacodyl Laxative used for?
Use for relief of occasional constipation and irregularity this product generally produces bowel movement in 1/4 to 1 hour

Who makes Bisacodyl Laxative?
InvaDerm Corporation is the labeler of record for Bisacodyl Laxative. 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 Laxative come in?
administered by rectal. Strengths and pack sizes vary by label, so compare the NDC on your pack with the identifier listed on this page.

Is Bisacodyl Laxative 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 Laxative been recalled?
No FDA recall record in our database matches this product name or manufacturer. Recall data is updated periodically, so a very recent notice may not appear here yet.

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.