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Floriva Tablets Prescribing Information

Package insert / product label
Generic name: sodium fluoride, multivitamins
Dosage form: chewable tablets
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Feb 4, 2024.

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 IU40%
Vitamin C (ascorbic acid)75 mg125%
Vitamin D3 (cholecalciferol)600 IU150%
Vitamin E (dl alpha tocopherol acetate)20 IU67%
Vitamin B1 (thiamine)1.3 mg87%
Vitamin B2 (riboflavin)1.5 mg88%
Niacin (nicotinamide)15 mg75%
Vitamin B6 (pyridoxine)1.8 mg90%
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 mcg66%
Vitamin B12 (cyanocobalamin)6 mcg100%
Biotin40 mcg13%
Zinc (zinc gluconate)5 mg33%
Copper (cupric oxide)1 mg50%
Fluoride (sodium fluoride)0.25 mg

Other Ingredients

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

Floriva Tablets 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.

Warnings

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.

Precautions

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.

Storage and Handling

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

PRINCIPAL DISPLAY PANEL - 90 Tablet Bottle Label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:52796-173
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1000 [iU]
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J) BETA CAROTENE1000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID75 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL600 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL20 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.5 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE15 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE1.8 mg
LEVOMEFOLATE GLUCOSAMINE (UNII: Q65PL71Q1A) (LEVOMEFOLATE GLUCOSAMINE - UNII:Q65PL71Q1A) LEVOMEFOLATE GLUCOSAMINE162 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID100 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN40 ug
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37) ZINC GLUCONATE5 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION1 mg
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O) FLUORIDE ION0.25 mg
Inactive Ingredients
Ingredient NameStrength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
XYLITOL (UNII: VCQ006KQ1E)
Product Characteristics
ColorWHITE (Off white, speckled) Score2 pieces
ShapeHEXAGON (6 SIDED)Size13mm
FlavorBERRYImprint Code173
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52796-173-9090 in 1 BOTTLE; Type 0: Not a Combination Product09/10/2015
2NDC:52796-173-1212 in 1 CARTON09/10/2015
21 in 1 BLISTER PACK; Type 0: Not a Combination Product
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER09/10/2015
Labeler - BonGeo Pharmaceuticals, Inc. (964822022)