Floriva
Floriva 0.25 mg DROPS
54eeeeda-9314-4b7c-9efc-0bedfffb91b6
HUMAN PRESCRIPTION DRUG LABEL
Feb 1, 2024
BonGeo Pharmaceuticals, Inc.
DUNS: 964822022
Products 1
Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.
CHOLECALCIFEROL and SODIUM FLUORIDE
Product Details
FDA regulatory identification and product classification information
FDA Identifiers
Product Classification
Product Specifications
INGREDIENTS (10)
Drug Labeling Information
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
52796-172-50
BonGeo™
PHARMACEUTICALS
Floriva™
0.25 mg DROPS
0.25 mg*
FLUORIDE
DROPS
Fluoride and Vitamin D
Liquid Drops
Fruit Flavor
Rx Dietary
Supplement
1 2/3 FL. OZ (50 mL)
SUGAR, SACCHARIN
AND GLUTEN FREE
NO ARTIFICIAL COLORS OR DYES
*contains 0.25 mg fluoride from 0.55 mg sodium fluoride
INDICATIONS & USAGE SECTION
How to Use
Fill dropper to appropriate line and dispense with a single squeeze of the dropper bulb. The full dose will be given. It is normal for a small amount to remain in the tip of the dropper.
Do not accept if tamper evident box seal is broken or missing.
The manufacturer of this product requires that it be dispensed only under the order of a physician or licensed medical practitioner.
DOSAGE & ADMINISTRATION SECTION
Directions
Use as directed by a physician
DESCRIPTION SECTION
|
Supplement Facts | ||
|---|---|---|
|
Serving Size: 1 mL | ||
|
Servings Per Container: 50 | ||
|
Amount per serving |
% Daily Value* | |
| ||
|
Vitamin D |
400 IU |
100% |
|
Fluoride (sodium fluoride) |
0.25 mg |
† |
Other Ingredients: Glycerin, water, polysorbate 80, sodium hydroxide, propylene glycol, sucralose, fruit flavor, methyl paraben, caramel color and propyl paraben.
WARNINGS SECTION
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.
SHAKE WELL BEFORE USE
SPL UNCLASSIFIED SECTION
The numeric identifer 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.
Manufactured for:
BonGeo Pharmaceuticals, Inc.
Roseland, NJ 07068
Manufactured by:
Sancilio & Co., Inc.
Riviera Beach, FL 33404
LOT/EXP