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

Floriva by

Drug Labeling and Warnings

Floriva by is a Prescription medication manufactured, distributed, or labeled by BonGeo Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

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.

SPL UNCLASSIFIED SECTION

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

INGREDIENTS AND APPEARANCE

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	Item Code (Source)	NDC: 52796-173
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1000 [iU]
BETA CAROTENE (UNII: 01YAE03M7J) (BETA CAROTENE - UNII:01YAE03M7J)	BETA CAROTENE	1000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	75 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	600 [iU]
.ALPHA.-TOCOPHEROL (UNII: H4N855PNZ1) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1)	.ALPHA.-TOCOPHEROL	20 [iU]
THIAMINE (UNII: X66NSO3N35) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE	1.3 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.5 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	15 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	1.8 mg
LEVOMEFOLATE GLUCOSAMINE (UNII: Q65PL71Q1A) (LEVOMEFOLATE GLUCOSAMINE - UNII:Q65PL71Q1A)	LEVOMEFOLATE GLUCOSAMINE	162 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	100 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	6 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	40 ug
ZINC GLUCONATE (UNII: U6WSN5SQ1Z) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLUCONATE	5 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1 mg
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SUCRALOSE (UNII: 96K6UQ3ZD4)
TALC (UNII: 7SEV7J4R1U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
XYLITOL (UNII: VCQ006KQ1E)

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	Marketing Start Date	Marketing End Date
1	NDC: 52796-173-90	90 in 1 BOTTLE; Type 0: Not a Combination Product	09/10/2015
2	NDC: 52796-173-12	12 in 1 CARTON	09/10/2015
2		1 in 1 BLISTER PACK; Type 0: Not a Combination Product

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)