Stratuscare Bisacodyl

Stratuscare Bisacodyl is an FDA-registered drug product whose active ingredient is BISACODYL. It is labelled by Stratus Pharmaceuticals taken by rectal and marketed as a human otc drug product. Identifiers on file: NDC 58980-415, application M007, label effective 20260609. 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.

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

Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 15 minutes to 1 hour

Directions Adults and children 12 years of age and older Children 6 to under 12 years Children under 6 One suppository once daily 1/2 suppository once daily Ask a doctor Detach one suppository from the strip and remove from foil Carefully insert well into rectum Do not use more than once per day

Warning for rectal use only Do not use more than once per day for a period of longer than one week unless directed by a doctor laxative products when abdominal pain, nausea or vomiting are present unless directed by a doctor Ask a doctor before use if you have noticed a sudden change in bowel habits that persist over a period of two weeks When using this product you may have abdominal discomfort, faintness, rectal burning and mild cramps Stop use and ask a doctor if you have rectal bleeding or fail to have a bowel movement after use of a laxative because this may indicate a serious condition. 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.

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.

1 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.

What is Stratuscare Bisacodyl used for?
Uses for relief of occasional constipation and irregularity this product generally produces bowel movement in 15 minutes to 1 hour

Who makes Stratuscare Bisacodyl?
Stratus Pharmaceuticals is the labeler of record for Stratuscare 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 Stratuscare Bisacodyl 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 Stratuscare 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 Stratuscare Bisacodyl been recalled?
1 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.