FLORIVA- cholecalciferol and sodium fluoride liquid

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]

DESCRIPTION

Supplement Facts
Serving Size: 1 mL
Servings Per Container: 50
	Amount per serving	% Daily Value*
* Percent Daily Value (%DV) based on a 2000 calorie diet. † Daily Value not established.
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.

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

Directions

Use as directed by a physician

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.

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) since these may decrease effectiveness. Prolonged daily ingestion of excessive fluoride may result in varying degrees of dental fluorosis.

OTHER INFORMATION

You may report serious side effects to 1-844-640-7607.

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

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

INGREDIENTS AND APPEARANCE

FLORIVA 
cholecalciferol and sodium fluoride liquid

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 52796-172
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]  in 1 mL
SODIUM FLUORIDE (UNII: 8ZYQ1474W7) (FLUORIDE ION - UNII:Q80VPU408O)	FLUORIDE ION	0.25 mg  in 1 mL

Inactive Ingredients
Ingredient Name	Strength
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
SODIUM HYDROXIDE (UNII: 55X04QC32I)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
SUCRALOSE (UNII: 96K6UQ3ZD4)
METHYLPARABEN (UNII: A2I8C7HI9T)
PROPYLPARABEN (UNII: Z8IX2SC1OH)

Product Characteristics
Color	BROWN	Score
Shape		Size
Flavor	FRUIT	Imprint Code
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 52796-172-50	1 in 1 BOX	10/15/2014
1		50 mL in 1 BOTTLE, DROPPER; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		10/15/2014

Labeler - BonGeo Pharmaceuticals, Inc. (964822022)