FDA Label for Floriva
View Indications, Usage & Precautions
Floriva Product Label
The following document was submitted to the FDA by the labeler of this product Bongeo Pharmaceuticals, Inc.. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
| 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. | |
| 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 Daily Value not established. , 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) | 0.5 mg |
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.
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 20-25° 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.
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 •
* Please review the disclaimer below.