FDA.reportPublic FDA data

FEVIA Diarrhea control 48

Manufacturer
VIVUNT PHARMA LLC | MEDGEL PRIVATE LIMITED
Effective date
2026-07-16
Label type
HUMAN OTC DRUG LABEL
Version
3
Source
daily-update
Hydrated at
2026-07-21 05:10:22

Label at a glance#

ProductFEVIA Diarrhea Control
Active ingredientBISMUTH SUBSALICYLATE
Label structure10 sections

Indications and uses

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

Dosage and administration

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 he...

Label contents#

Full prescribing information#

Drug Facts

OTC - ACTIVE INGREDIENT SECTION

Active ingredient (in each softgel)

Bismuth subsalicylate 262 mg

Purpose

OTC - PURPOSE SECTION

Upset stomach reliever and antidiarrheal

Uses

INDICATIONS & USAGE SECTION

Relieves:

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

Warnings

WARNINGS SECTION

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

OTC - DO NOT USE SECTION

  • an ulcer
  • a bleeding problem
  • bloody or block stool

Ask a doctor before use if you have

OTC - ASK DOCTOR SECTION

  • fever
  • mucus in the stool
  • anticoagulation (thinning the blood)
  • diabetes
  • gout
  • arthritis

When using this product

OTC - WHEN USING SECTION

a temporary, but harmless, darkening of the stool and/or tongue may occur

Stop use and ask a doctor if

OTC - STOP USE SECTION

  • 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,

OTC - PREGNANCY OR BREAST FEEDING SECTION

ask a health professional before use.

Keep out of reach of children

OTC - KEEP OUT OF REACH OF CHILDREN SECTION

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.

Directions

DOSAGE & ADMINISTRATION SECTION

  • 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

Other information

OTHER SAFETY INFORMATION

  • store at room temperature 20°-25°C (68°-77°F)
  • Protect from light, heat and moisture

Inactive ingredients

INACTIVE INGREDIENT SECTION

Beeswax, Colloidal Silicon Dioxide, Gelatin, Glycerin, Medium Chain Triglycerides, Polysorb, Povidone K-30, Purified Water, Sodium Carboxymethylcellulose, Sorbitol 70%, Soy Lechitin, Titanium Dioxide.

Distributed by

SPL UNCLASSIFIED SECTION

VIVUNT

Distributed by: VIVUNT PHARMA LLC

8950 SW 74th Court, Suite 1901

Miami, FL 33156-3178, USA.

Product from India.

www.vivunt.live

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

Fevia™

Diarrhea Control

Antidiarrheal

Fast relief for upset stomach

Bismuth Subsalicylate 262 mg

48 SOFTGELS

TAMPER EVIDENT: DO NOT USE IF CARTON IS OPENED OR IF SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

Sugar Free

Actual size

PDPPDP

PDP interiorPDP interior

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
0be8e4ae-4d57-49f3-b3a9-e4728b4e8d15Product name120240313
dea2eded-d1e7-46bb-9a3d-f8dc20de6277Product name120190408

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 14 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
82706-02882706-028-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 12 matching rows.

Name, UNII, Kind table
NameUNIIKind
GLYCERINPDC6A3C0OXIACT
SOYBEAN LECITHIN1DI56QDM62IACT
BISMUTH SUBSALICYLATE62TEY51RR1ACTIB
TITANIUM DIOXIDE15FIX9V2JPIACT
SILICON DIOXIDEETJ7Z6XBU4IACT
POVIDONE K30U725QWY32XIACT
BEESWAX2ZA36H0S2VIACT
GELATIN2G86QN327LIACT
CARBOXYMETHYLCELLULOSE SODIUMK679OBS311IACT
SORBITOL SOLUTION 70%8KW3E207O2IACT
MEDIUM-CHAIN TRIGLYCERIDESC9H2L21V7UIACT
WATER059QF0KO0RIACT

Source Document#

Source XML

Older Hydrated Versions#

Version, Effective date, Source table
VersionEffective dateSourceHydrated
22026-02-26full-release2026-06-01 01:47:44
12026-02-18monthly-update2026-06-03 17:56:43

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 2 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4b20f189-e979-8198-e063-6294a90a71692026-07-16WarningsExact identifier
ndc (package): 82706-028-01
ndc (product): 82706-028
ndc11 (package): 82706002801
spl id: 56bc3b3b-c706-00ac-e063-6294a90aaffe
spl set id: 4b20f189-e979-8198-e063-6294a90a7169
FEVIA Diarrhea ControlBISMUTH SUBSALICYLATEVIVUNT PHARMA LLC4bd5aa23-37aa-b818-e063-6394a90ae06c2026-07-15WarningsExact identifier
ndc (product): 82706-028

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.