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Floriva Tablets

Generic Name: sodium fluoride, multivitamins
Dosage Form: chewable tablets

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Supplement Facts
Serving Size: 1 tablet
Servings Per Container: 90
Amount per tablet % Daily Value*
*
Percent Daily Value (%DV) for Adults and Children 4 or more years of age based on a 2000 calorie diet.
Daily Value not established.
Vitamin A (50% beta carotene/50% acetate) 2000 IU 40%
Vitamin C (ascorbic acid) 75 mg 125%
Vitamin D3 (cholecalciferol) 600 IU 150%
Vitamin E (dl alpha tocopherol acetate) 20 IU 67%
Vitamin B1 (thiamine) 1.3 mg 87%
Vitamin B2 (riboflavin) 1.5 mg 88%
Niacin (nicotinamide) 15 mg 75%
Vitamin B6 (pyridoxine) 1.8 mg 90%
Folate (as 300 mcg Quatrefolic R ((6S-5-methyltetrahydrofolic acid, glucosamine salt, molar equivalent to 162 mcg of folic acid) and 100 mcg of folic acid)
Quatrefolic CAS #: 1181972-37-1
262 mcg 66%
Vitamin B12 (cyanocobalamin) 6 mcg 100%
Biotin 40 mcg 13%
Zinc (zinc gluconate) 5 mg 33%
Copper (cupric oxide) 1 mg 50%
Fluoride (sodium fluoride) 0.25 mg

Other Ingredients

Natural berry flavor, bitterness masking agent, MCC, sucralose, talc, magnesium stearate, xylitol (DC and regular grade).

Description

Off-white to pale yellow, speckled, berry flavored, hexagon shaped chewable tablet. Debossed "173" on one side and scored on the other.

Quatrefolic Trademark and Patent property of Gnosis SpA.

Directions

USE AS DIRECTED BY YOUR PHYSICIAN.

Tamper Evident Feature

Do not use if inner-seal beneath cap is missing or broken.

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.

CAUTION

Do not use this product if you are allergic to any of the ingredients. Take this product at least 2 hours before or after taking any products containing calcium (including milk, yogurt, other dairy products) or aluminum/magnesium hydroxide (e.g., certain antacids/laxatives). Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis. Account for all daily sources of fluoride intake.

OTHER INFORMATION

You may report serious side effects to 1-844-640-7607. Store in a cool, dry place at room temperature 20-25° Celsius (68-77° 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.

Manufactured for:
BonGeo Pharmaceuticals, Inc.
Roseland, NJ 07068

Manufactured by:
Sancilio & Co., Inc.
Riviera Beach, FL 33404

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label

0.25 mg* FLUORIDE
MULTIVITAMIN TABLETS

BonGeo
PHARMACEUTICALS

52796-173-90

Floriva

.25 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 0.25 mg fluoride
from .55 mg sodium fluoride

SUGAR FREE AND GLUTEN FREE
NO ARTIFICIAL COLORS OR DYES

FLORIVA 
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 tablet, chewable
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52796-173
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1000 [iU]
.BETA.-CAROTENE (.BETA.-CAROTENE) .BETA.-CAROTENE 1000 [iU]
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 75 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 600 [iU]
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 20 [iU]
THIAMINE (THIAMINE ION) THIAMINE 1.3 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.5 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 15 mg
PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 1.8 mg
LEVOMEFOLATE GLUCOSAMINE (LEVOMEFOLATE GLUCOSAMINE) LEVOMEFOLATE GLUCOSAMINE 162 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 100 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6 ug
BIOTIN (BIOTIN) BIOTIN 40 ug
ZINC GLUCONATE (ZINC CATION) ZINC GLUCONATE 5 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 1 mg
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
SUCRALOSE  
TALC  
MAGNESIUM STEARATE  
XYLITOL  
Product Characteristics
Color WHITE (Off white, speckled) Score 2 pieces
Shape HEXAGON (6 SIDED) Size 13mm
Flavor BERRY Imprint Code 173
Contains         
Packaging
# Item Code Package Description
1 NDC:52796-173-90 90 TABLET, CHEWABLE in 1 BOTTLE
2 NDC:52796-173-12 12 BLISTER PACK in 1 CARTON
2 1 TABLET, CHEWABLE in 1 BLISTER PACK
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 09/10/2015
Labeler - BonGeo Pharmaceuticals, Inc. (964822022)
Revised: 09/2015
 
BonGeo Pharmaceuticals, Inc.



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