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.
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. | |
| Vitamin D | 400 IU | 100% |
| Fluoride (sodium fluoride) | 0.25 mg | Daily Value not established. |
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.
Other
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
* Please review the disclaimer below.