Pepto Bismol CHEWABLES

Pepto Bismol CHEWABLES is an FDA-registered drug product whose active ingredient is BISMUTH SUBSALICYLATE. It is labelled by Select Consumer Group taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 85237-1903, application M008, label effective 20260707. 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, heartburn indigestion, nausea gas, belching fullness. 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 in food and drink, including: heartburn indigestion nausea gas belching fullness

Directions • chew or dissolve in mouth • adults and children 12 years and over: 2 tablets (1 dose) every 1/2 hour or 4 tablets (2 doses) every hour as needed for diarrhea 2 tablets (1 dose) every 1/2 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) • do not exceed 8 doses (16 tablets) 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. Allergy alert: Contains salicylate. Do not take if you are allergic to salicylates (including aspirin) taking other salicylate products

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 Pepto Bismol CHEWABLES used for?
Uses relieves travelers' diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Who makes Pepto Bismol CHEWABLES?
Select Consumer Group is the labeler of record for Pepto Bismol CHEWABLES. 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 Pepto Bismol CHEWABLES 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 Pepto Bismol CHEWABLES 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 Pepto Bismol CHEWABLES 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.