Drug Facts
Active ingredient (in each softgel)
Bismuth subsalicylate 262 mg
Fevia Diarrhea Control Capsule, Liquid Filled
FDA Label NDC 82706-028
Full FDA labeling including Indications, Dosage, Usage, and Precautions
Structured Product Label
The following Structured Product Label (SPL) was submitted to the FDA by Vivunt Pharma Llc for the product Fevia Diarrhea Control (NDC 82706-028). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.
This specific version of the label includes detailed information regarding drug facts, purpose, uses, warnings, do not use if you have, ask a doctor before use if you have, when using this product, stop use and ask a doctor if, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.
Label Section Quick Index
Purpose
Upset stomach reliever and antidiarrheal
Uses
Relieves:
- traveler´s diarrhea
- diarrhea
- upset stomach due to overindulgence in food and drink, including:
- heartburn
- indigestion
- nausea
- gas
- belching
- fullness
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.
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
Other Information
- store at room temperature 20°-25°C (68°-77°F)
- Protect from light, heat and moisture
Inactive Ingredients
Beeswax, Colloidal Silicon Dioxide, Gelatin, Glycerin, Medium Chain Triglycerides, Polysorb, Povidone K-30, Purified Water, Sodium Carboxymethylcellulose, Sorbitol 70%, Soy Lechitin, Titanium Dioxide.
Questions?
Visit www.fevia.live
Distributed By
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
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
* Please review the disclaimer below.
