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 
BonGeo Pharmaceuticals, Inc.

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.

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Floriva
0.5 mg TABLETS

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 #: 1181972-37-1262 mcg 66%
Vitamin B12 (cyanocobalamin)6 mcg100%
Biotin40 mcg13%
Zinc (zinc gluconate)5 mg33%
Copper (cupric oxide)1 mg50%
Fluoride (sodium fluoride)0.5 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 "174" on one side and scored on the other.

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 20-25º 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.

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.

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 •

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:52796-174
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 ION0.5 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 Code 174
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:52796-174-9090 in 1 BOTTLE; Type 0: Not a Combination Product10/15/2014
2NDC:52796-174-011 in 1 CARTON10/15/2014
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 OTHER10/15/2014
Labeler - BonGeo Pharmaceuticals, Inc. (964822022)

Revised: 2/2024
Document Id: 6c1b33d4-bbb3-434e-b5ed-f3cc77c8d0d9
Set id: 34b2924f-d220-4344-8cdd-e7dda54061c2
Version: 4
Effective Time: 20240202
 
BonGeo Pharmaceuticals, Inc.