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.
|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.
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
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.
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.
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.
BonGeo Pharmaceuticals, Inc.
Roseland, NJ 07068
Sancilio & Co., Inc.
Riviera Beach, FL 33404
PRINCIPAL DISPLAY PANEL - 50 mL Bottle Label
0.25 mg DROPS
Fluoride and Vitamin D
1 2/3 FL. OZ (50 mL)
AND GLUTEN FREE
NO ARTIFICIAL COLORS OR DYES
*contains 0.25 mg fluoride from 0.55 mg sodium fluoride
cholecalciferol and sodium fluoride liquid
|Labeler - BonGeo Pharmaceuticals, Inc. (964822022)|
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- Drug class: vitamin and mineral combinations