Floriva
Floriva 0.5 mg TABLETS
34b2924f-d220-4344-8cdd-e7dda54061c2
HUMAN PRESCRIPTION DRUG LABEL
Feb 2, 2024
BonGeo Pharmaceuticals, Inc.
DUNS: 964822022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
VITAMIN A ACETATE, .BETA.-CAROTENE, Ascorbic acid, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL, THIAMINE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE, LEVOMEFOLATE GLUCOSAMINE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, ZINC GLUCONATE, CUPRIC OXIDE, and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (21)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
0.5 mg*
FLUORIDE
TABLETS
BonGeo**™******
PHARMACEUTICALS
52796-174-90
Floriva**™******
** 0.5 mg TABLETS**
Chewable Fluoride Multivitamin
Quatrefolic®
Patent Ref.: U.S. Patent No. 7,947,662;
Other patents pending
Natural Berry Flavor
Rx Dietary Supplement
90 Chewable Tablets
*contains 0.5 mg fluoride
from 1.1 mg sodium fluoride
• SUGAR FREE AND GLUTEN FREE • NO ARTIFICIAL COLORS OR DYES •
SPL UNCLASSIFIED SECTION
Manufactured for:
BonGeo Pharmaceuticals, Inc.
Roseland, NJ 07068
Manufactured by:
Sancilio & Co., Inc.
Riviera Beach, FL 33404
LOT/EXP
Quatrefolic Trademark and Patent property of Gnosis SpA.
DESCRIPTION SECTION
Description
Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "174" on one side and scored on the other.
DOSAGE & ADMINISTRATION SECTION
Directions
USE AS DIRECTED BY YOUR PHYSICIAN.
WARNINGS SECTION
WARNING
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. IF OVERDOSAGE IS SUSPECTED, SEEK PROFESSIONAL ASSISTANCE OR CONTACT A POISON CONTROL CENTER IMMEDIATELY 1-800-222-1222. TABLET SHOULD BE CHEWED. THIS TABLET, AS WITH ALL TABLETS, IS NOT RECOMMENDED FOR CHILDREN UNDER AGE OF 4 DUE TO RISK OF CHOKING.
STORAGE AND HANDLING SECTION
OTHER INFORMATION
You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25º Celsius (68-77º Fahrenheit) away from heat and sunlight. Store in original container.
The numeric identifier on this product's labeling is an assigned product code for use with pharmacy-level, health insurance and state level reimbursement programs and is not intended to denote registration with the FDA.
The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.