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Floriva Drops

Generic Name: cholecalciferol and sodium fluoride
Dosage Form: liquid

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.

Floriva
0.25 mg DROPS

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.

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

FLORIVA 
cholecalciferol and sodium fluoride liquid
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52796-172
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
GLYCERIN  
WATER  
POLYSORBATE 80  
SODIUM HYDROXIDE  
PROPYLENE GLYCOL  
SUCRALOSE  
METHYLPARABEN  
PROPYLPARABEN  
Product Characteristics
Color BROWN Score     
Shape Size
Flavor FRUIT Imprint Code
Contains         
Packaging
# Item Code Package Description
1 NDC:52796-172-50 1 BOTTLE, DROPPER in 1 BOX
1 50 mL in 1 BOTTLE, DROPPER
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)
Revised: 10/2014
 
BonGeo Pharmaceuticals, Inc.



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