Bismuth Subsalicylate 262 mg

Bismuth Subsalicylate 262 mg is an FDA-registered drug product whose active ingredient is BISMUTH SUBSALICYLATE. It is labelled by Preferred Pharmaceuticals Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 68788-4116, application M008, label effective 20260608. It is one of 62 FDA drug label records sharing the active ingredient BISMUTH SUBSALICYLATE. 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 BISMUTH SUBSALICYLATE are most often described in connection with: controls diarrhea, relieves upset, stomach due, overindulgence food. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses • controls diarrhea • relieves upset stomach due to overindulgence in food or drink

Directions • drink plenty of clear fluids to help prevent dehydration caused by diarrhea • repeat dosage every 1/2 to 1 hour as needed • do not take more than 8 doses in 24 hours • use until diarrhea stops but not more than 2 days • adults and children 12 years and over: 2 tablets • children under 12 years: ask a doctor

Warnings Reye's syndrome: Children and teenagers who have or are recovering from chicken pox or flu-like symptoms should not use this product. When using this product, if changes in behavior with nausea and vomiting occur, consult a doctor because these symptoms could be an early sign of Reye's syndrome, a rare but serious illness.

FDA lists 62 drug label records with BISMUTH SUBSALICYLATE 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.

What is Bismuth Subsalicylate 262 mg used for?
Uses • controls diarrhea • relieves upset stomach due to overindulgence in food or drink

Who makes Bismuth Subsalicylate 262 mg?
Preferred Pharmaceuticals Inc. is the labeler of record for Bismuth Subsalicylate 262 mg. 62 FDA label records share the active ingredient BISMUTH SUBSALICYLATE, 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 Bismuth Subsalicylate 262 mg 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 Bismuth Subsalicylate 262 mg 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 BISMUTH SUBSALICYLATE?
Yes. 62 FDA drug label records list BISMUTH SUBSALICYLATE 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 Bismuth Subsalicylate 262 mg 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.