FEVIA Diarrhea Control

BISMUTH SUBSALICYLATE ORAL HUMAN OTC DRUG

FEVIA Diarrhea Control is an FDA drug label for the active ingredient BISMUTH SUBSALICYLATE manufactured by VIVUNT PHARMA LLC administered by ORAL. 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 20260716.

Generic name
BISMUTH SUBSALICYLATE
Manufacturer
VIVUNT PHARMA LLC
Product type
HUMAN OTC DRUG
Route
ORAL
Dosage form
N/A
NDC
82706-028
Application
M008
Label effective
20260716

About this product

FEVIA Diarrhea Control is an FDA-registered drug product whose active ingredient is BISMUTH SUBSALICYLATE. It is labelled by VIVUNT PHARMA LLC taken by oral and marketed as a human otc drug product. Identifiers on file: NDC 82706-028, application M008, label effective 20260716. 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.

What it is used for

Across FDA labelling, products containing BISMUTH SUBSALICYLATE are most often described in connection with: relieves traveler, 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.

Active ingredients

Drug Facts Active ingredient (in each softgel) Bismuth subsalicylate 262 mg

Indications & Usage

Uses Relieves: traveler´s diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Dosage & Administration

Directions swallow with water, do not chew adults and children 12 years and over: 2 softgels every 1/2 hour or 4 softgels every hour as needed for diarrhea 2 softgels every 1/2 hour to 1 hour as needed for overindulgence (upset stomach, heartburn, indigestion, nausea) do not exceed 16 softgels in 24 hours use until diarrhea stops but no more than 2 days children under 12 years: ask a doctor drink plenty of clear fluids to help revent dehydration caused by diarrhea

Warnings

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 behaviour 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 Do not use if you have an ulcer a bleeding problem bloody or block stool Ask a doctor before use if you have fever mucus in the stool anticoagulation (thinning the blood) diabetes gout arthritis When using this product a temporary, but harmless, darkening of the stool and/or tongue may occur Stop use and ask a doctor if symptoms get worse or last more than 2 days ringing in the ears or loss of hearing occurs diarrhea lasts more than 2 days If pregnant or breast-feeding, ask a health professional before use. Keep out of reach of children Keep out of reach of children. In case of overdose, get medical help or contact a Poison Control Center (1-800-222-1222) right away.

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How products containing BISMUTH SUBSALICYLATE compare

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.

Dosage formProductsManufacturerProducts
— — AptaPharma Inc. 4
— — CVS 3
— — KROGER COMPANY 3
— — Allegiant Health 2
— — CVS PHARMACY, INC. 2

Frequently asked questions

What is FEVIA Diarrhea Control used for?
Uses Relieves: traveler´s diarrhea diarrhea upset stomach due to overindulgence in food and drink, including: heartburn indigestion nausea gas belching fullness

Who makes FEVIA Diarrhea Control?
VIVUNT PHARMA LLC is the labeler of record for FEVIA Diarrhea Control. 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 FEVIA Diarrhea Control 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 FEVIA Diarrhea Control 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 FEVIA Diarrhea Control 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.