Floriva Plus

Name: Floriva Plus

What Is Floriva Plus?

Multivitamins provide essential vitamins and minerals that are not taken in to the body through diet.

Fluoride strengthens tooth enamel, which helps prevent dental cavities. In most major U.S. communities, fluoride is put into the water supply.

Multivitamins with fluoride are used as a supplement to the diet of infants and children who do not receive adequate fluoride through drinking water. Multivitamins with fluoride are also used to prevent tooth decay in people treated with radiation, which may cause dryness of the mouth and increased risk of tooth decay.

Multivitamins with fluoride may also be used for purposes not listed in this medication guide.

Do not use this medicine without the advice of a doctor. You should not use multivitamins with fluoride if the level of fluoride in your drinking water is adequate (0.6 parts per million or higher).Check with your local water department if you are unsure about the level of fluoride in the drinking water.

Taking in too much fluoride can cause an irreversible condition that can permanently damage teeth and possibly other cells in the body.

Seek emergency medical attention if you think you have used too much of this medicine. An overdose of certain vitamins or minerals contained in a multivitamin can cause serious or life-threatening side effects.

Do not use this medicine without the advice of a doctor. Multivitamins with fluoride should not be used if the level of fluoride in the drinking water is adequate (0.6 parts per million or higher). Check with your local water department if you are unsure about the level of fluoride in the drinking water.

Your vitamin and mineral needs may be different during pregnancy. It is not known whether fluoride will harm an unborn baby. Do not use this medicine without a doctor's advice if you are pregnant.

Your dose needs may also be different while you are nursing. Do not use this medicine without a doctor's advice if you are breast-feeding a baby.

Do not give this medicine to a child without medical advice.

Floriva Plus Interactions

Avoid taking any other multivitamin product within 2 hours before or after you take multivitamins with fluoride. Taking similar vitamin products together at the same time can result in a vitamin overdose or serious side effects.

Also avoid taking an antibiotic medicine within 2 hours before or after you take multivitamins with fluoride. This is especially important if you are taking an antibiotic.

Do not take this medicine with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may make it harder for your body to absorb certain ingredients of the multivitamin.

Other drugs may interact with multivitamins with fluoride, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell each of your health care providers about all medicines you use now and any medicine you start or stop using.

Other information

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

†BonGeo Pharmaceuticals, Inc. requires this product to be dispensed only under the order of a physician or licensed medical practitioner.

© 2016
BonGeo Pharmaceuticals, Inc.
101 Eisenhower Parkway #300, Roseland, NJ 07068
FPL02 04/16

PRINCIPAL DISPLAY PANEL - 50 mL Container Label

NDC 52796-171-50

BonGeo™
PHARMACEUTICALS

FlorivaPlus™
0.25 mg DROPS

0.25
mg*
FLUORIDE
MULTIVITAMIN
LIQUID DROPS

Fluoride Multivitamin
Liquid Drops

Quatrefolic®
Patent Ref.: U.S. Patent No. 7,947,662;
Other patents pending

Natural Berry Flavor

Rx
Dietary Supplement
1 ⅔ FL. OZ. (50 mL)

SUGAR, SACCHARIN
AND GLUTEN FREE
NO ARTIFICIAL COLORS OR FLAVORS

Dispense under a physician's order†
*contains 0.25 mg fluoride per 1 mL from 0.55 mg sodium fluoride
Quatrefolic Trademark and Patent property of Gnosis SpA.

Floriva Plus 
vitamin a acetate, ascorbic acid, cholecalciferol, .alpha.-tocopherol, thiamine hydrochloride, riboflavin 5-phosphate sodium, niacinamide, pyridoxine hydrochloride, levomefolate glucosamine, cyanocobalamin, biotin, pantothenic acid, and sodium fluoride solution/ drops
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:52796-171
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
VITAMIN A ACETATE (VITAMIN A) VITAMIN A 1150 [iU]  in 1 mL
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 32 mg  in 1 mL
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]  in 1 mL
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 5 [iU]  in 1 mL
THIAMINE HYDROCHLORIDE (THIAMINE ION) THIAMINE HYDROCHLORIDE 0.5 mg  in 1 mL
RIBOFLAVIN 5'-PHOSPHATE SODIUM (RIBOFLAVIN) RIBOFLAVIN 0.6 mg  in 1 mL
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 2 mg  in 1 mL
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 0.4 mg  in 1 mL
LEVOMEFOLATE GLUCOSAMINE (LEVOMEFOLATE GLUCOSAMINE) LEVOMEFOLATE GLUCOSAMINE 29.7 ug  in 1 mL
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 2 ug  in 1 mL
BIOTIN (BIOTIN) BIOTIN 3 ug  in 1 mL
PANTOTHENIC ACID (PANTOTHENIC ACID) PANTOTHENIC ACID 1 mg  in 1 mL
SODIUM FLUORIDE (FLUORIDE ION) FLUORIDE ION 0.25 mg  in 1 mL
Inactive Ingredients
Ingredient Name Strength
WATER  
GLYCERIN  
METHYLPARABEN  
POLYSORBATE 80  
SODIUM BENZOATE  
SODIUM HYDROXIDE  
CITRIC ACID MONOHYDRATE  
Product Characteristics
Color      Score     
Shape Size
Flavor BERRY Imprint Code
Contains     
Packaging
# Item Code Package Description
1 NDC:52796-171-50 50 mL in 1 CONTAINER
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
UNAPPROVED DRUG OTHER 06/20/2016
Labeler - BonGeo Pharmaceuticals, Inc. (964822022)
Revised: 06/2016   BonGeo Pharmaceuticals, Inc.

What are some other side effects of this drug?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your child's doctor or get medical help if any of these side effects or any other side effects bother your child or do not go away:

  • Upset stomach or throwing up.

These are not all of the side effects that may occur. If you have questions about side effects, call your child's doctor. Call your child's doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects at http://www.fda.gov/medwatch.

Some side effects of multivitamin with fluoride may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.

Liver Dose Adjustments

Data not available

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