Bismuth Subsalicylate Suspension Regular Strength

Bismuth Subsalicylate Suspension Regular Strength is an FDA-registered drug product whose active ingredient is BISMUTH SUBSALICYLATE. It is labelled by AptaPharma Inc. taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 76281-557, application M008, label effective 20260602. 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: relieves travelers, diarrhea diarrhea, upset stomach, due overindulgence, drink including, heart burn, indigestion nausea, gas belching. Wording differs between labels, and the full indications section on this page takes precedence when it is present.

Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach due to overindulgence of food and drink including: ■ heart burn ■ indigestion ■ nausea ■ gas ■ belching

Directions. ■ Shake well before use ■ use dose cup or tablespoon (TBSP) ■ adults and children 12 years and over: 1 dose (30 mL or 2 TBSP) every 1/2 to 1 hour as needed ■ do not exceed 8 doses (240 mL or 16 TBSP) in 24 hours ■ use until diarrhea stops but not more than 2 days ■ children under 12 years: ask a doctor ■ drink plenty of clear fluids to help prevent dehydration caused by diarrhea

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.

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 Bismuth Subsalicylate Suspension Regular Strength used for?
Uses relieves ■ travelers' diarrhea ■ diarrhea ■ upset stomach due to overindulgence of food and drink including: ■ heart burn ■ indigestion ■ nausea ■ gas ■ belching

Who makes Bismuth Subsalicylate Suspension Regular Strength?
AptaPharma Inc. is the labeler of record for Bismuth Subsalicylate Suspension Regular Strength. 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 Suspension Regular Strength 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 Suspension Regular Strength 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 Suspension Regular Strength 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.