Multivitamin, Iron and Fluoride (Poly-Vi-Flor)
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Multivitamin, Iron and Fluoride (Poly-Vi-Flor)

DRUG DESCRIPTION

DROPS POLY-VI. FLOR®
MULTIVITAMIN, IRON AND FLUORIDE SUPPLEMENT

Active Ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, ferrous sulfate, fruit flavor (artificial), glycerin, niacinamide, polysorbate 80, pyridoxine hydrochloride, riboflavin-5-phosphate sodium, thiamin hydrochloride, d-alphatocopheryl acid succinate, vitamin A palmitate, water, and other ingredients.

Nutrition Facts
Dosage Size 1 mL (Mark on Dropper)

Amount Per 1mL
% DV
Infants
%DV
Children Under
Age 4 Years

Vitamin A 1500 IU

100%
60%
Vitamin C 35 mg
100%
88%
Vitamin D 400 IU
100%
100%
Vitamin E 5 IU
100%
50%
Thiamin 0.5 mg
100%
71%
Riboflavin 0.6 mg
100%
75%
Niacin 8 mg
100%
89%
Vitamin B6 0.4 mg
100%
57%
Iron 10 mg
67%
100%
Fluoride 0.25 mg
*
*
* Daily Value (DV) not established

What are the possible side effects of multivitamin with fluoride?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause the tooth enamel to become discolored. This is a rare side effect that has occurred mainly with large doses or long-term use of multivitamin with fluoride. Stop using this medication and call your dentist or doctor at once if you notice any change in the appearance of your teeth.

Less serious side effects may include:

  • stomach upset;
  • headache;...

Read All Potential Side Effects and See Pictures of Poly-Vi-Flor »

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

INDICATIONS

Supplementation of the diet with eight essential vitamins and iron.

Supplementation of the diet with fluoride for caries prophylaxis.

The American Academy of Pediatrics recommends that children up to age 16, in areas where drinking water contains less than optimal levels of fluoride, receive daily fluoride supplementation.²

POLY- VI- FLOR 0.25 mg with Iron drops provide fluoride in drop form for infants and young children from 6 months to 3 years of age in areas where the drinking water contains less than 0.3 ppm of fluoride and for children ages 3-6 years in areas where the drinking water contains 0.3 through 0.6 ppm of fluoride.² Each 1.0 mL supplies sodium fluoride (0. 25 mg fluoride) plus eight essential vitamins and iron.

POLY-VI-FLOR (multivitamin, iron and fluoride) ® 0.25 mg with Iron drops supply significant amounts of vitamins A, C, D, E, thiamin, riboflavin, niacin, vitamin B6, and Iron to supplement the diet, and to help assure that deficiencies of these nutrients will not develop. Thus, in a single easy-to-use preparation, infants and children obtain eight essential vitamins and iron, plus fluoride.

DOSAGE AND ADMINISTRATION

1.0 mL daily or as prescribed. May be dropped directly into mouth with 'Safti- Dropper,' or mixed with cereal, fruit juice, or other food.

HOW SUPPLIED

POLY-VI-FLOR 0. 25 mg with Iron (Multivitamin, iron and fluoride supplement) drops are available on prescription only in bottles of 50 mL.

REFERENCES

1. Brudevold F, McCann HG. Fluoride and caries control - Mechanism of action. In: Nizel AE, ed. The Science of Nutrition and Its Application In Clinical Dentistry. Philadelphia: WB Saunders Co.; 1966: 331- 347.

2. American Academy of Pediatrics, Committee on Nutrition. Fluoride Supplementation for Children: Interim Policy Recommendations. Pediatrics. 1995; 95: 777.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

SIDE EFFECTS

Allergic rash and other idiosyncrasies have been rarely reported.

Read the Poly-Vi-Flor (multivitamin, iron and fluoride) Side Effects Center for a complete guide to possible side effects »

DRUG INTERACTIONS

No information provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

WARNINGS

Close tightly and keep out of reach of children. Contains Iron, which can be harmful or fatal to children in large doses. In case of accidental overdose, seek professional assistance or contact a Poison Control Center immediately.

PRECAUTIONS

The suggested dose should not be exceeded since dental fluorosis may result from continued ingestion of large amounts of fluoride.

When prescribing VI-FLOR™ products:

1. Determine the fluoride content of the drinking water from all major sources.

2. Make sure the child is not receiving significant amounts of fluoride from other sources such as medications and swallowed toothpaste.

3. Periodically check to make sure that the child does not develop significant dental fluorosis.

POLY-VI-FLOR (multivitamin, iron and fluoride) 0.25 mg with Iron drops should be dispensed in the original plastic container, since contact with glass leads to instability and precipitation. (The amount of sodium fluoride in the 50 mL size is well below the maximum to be dispensed at one time according to recommendations of the American Dental Association.)

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

OVERDOSE

No information provided.

CONTRAINDICATIONS

No information provided.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

CLINICAL PHARMACOLOGY

It is well established that fluoridation of the water supply (1 ppm fluoride) during the period of tooth development leads to a significant decrease in the incidence of dental caries.

Hydroxyapatite is the principal crystal for all calcified tissue in the human body. The fluoride ion reacts with the hydroxyapatite in the tooth as it is formed to produce the more caries-resistant crystal, fluorapatite. The reaction may be expressed by the equation:¹

Ca10(PO4)6(OH)2+2F ¯ > Ca10(PO4)6F2+2OH ¯
(Hydroxyapatite)   (Fluorapatite)

Three stages of fluoride deposition in tooth enamel can be distinguished:¹

1. Small amounts (reflecting the low levels of fluoride in tissue fluids) are incorporated into the enamel crystals while they are being formed.

2. After enamel has been laid down, fluoride deposition continues in the surface enamel. Diffusion of fluoride from the surface inward is apparently restricted.

3. After eruption, the surface enamel acquires fluoride from water, food, supplementary fluoride, and smaller amounts from saliva.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

PATIENT INFORMATION

See WARNINGS and PRECAUTIONS.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

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PATIENT INFORMATION

See WARNINGS and PRECAUTIONS.

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

DROPS POLY-VI. FLOR®
MULTIVITAMIN, IRON AND FLUORIDE SUPPLEMENT

Active Ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, ferrous sulfate, fruit flavor (artificial), glycerin, niacinamide, polysorbate 80, pyridoxine hydrochloride, riboflavin-5-phosphate sodium, thiamin hydrochloride, d-alphatocopheryl acid succinate, vitamin A palmitate, water, and other ingredients.

Nutrition Facts
Dosage Size 1 mL (Mark on Dropper)

Amount Per 1mL
% DV
Infants
%DV
Children Under
Age 4 Years

Vitamin A 1500 IU

100%
60%
Vitamin C 35 mg
100%
88%
Vitamin D 400 IU
100%
100%
Vitamin E 5 IU
100%
50%
Thiamin 0.5 mg
100%
71%
Riboflavin 0.6 mg
100%
75%
Niacin 8 mg
100%
89%
Vitamin B6 0.4 mg
100%
57%
Iron 10 mg
67%
100%
Fluoride 0.25 mg
*
*
* Daily Value (DV) not established

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

DROPS POLY-VI. FLOR®
MULTIVITAMIN, IRON AND FLUORIDE SUPPLEMENT

Active Ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, ferrous sulfate, fruit flavor (artificial), glycerin, niacinamide, polysorbate 80, pyridoxine hydrochloride, riboflavin-5-phosphate sodium, thiamin hydrochloride, d-alphatocopheryl acid succinate, vitamin A palmitate, water, and other ingredients.

Nutrition Facts
Dosage Size 1 mL (Mark on Dropper)

Amount Per 1mL
% DV
Infants
%DV
Children Under
Age 4 Years

Vitamin A 1500 IU

100%
60%
Vitamin C 35 mg
100%
88%
Vitamin D 400 IU
100%
100%
Vitamin E 5 IU
100%
50%
Thiamin 0.5 mg
100%
71%
Riboflavin 0.6 mg
100%
75%
Niacin 8 mg
100%
89%
Vitamin B6 0.4 mg
100%
57%
Iron 10 mg
67%
100%
Fluoride 0.25 mg
*
*
* Daily Value (DV) not established

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

DRUG DESCRIPTION

DROPS POLY-VI. FLOR®
MULTIVITAMIN, IRON AND FLUORIDE SUPPLEMENT

Active Ingredient for caries prophylaxis: Fluoride as sodium fluoride.

Other Ingredients: Ascorbic acid, caramel color, cholecalciferol, ferrous sulfate, fruit flavor (artificial), glycerin, niacinamide, polysorbate 80, pyridoxine hydrochloride, riboflavin-5-phosphate sodium, thiamin hydrochloride, d-alphatocopheryl acid succinate, vitamin A palmitate, water, and other ingredients.

Nutrition Facts
Dosage Size 1 mL (Mark on Dropper)

Amount Per 1mL
% DV
Infants
%DV
Children Under
Age 4 Years

Vitamin A 1500 IU

100%
60%
Vitamin C 35 mg
100%
88%
Vitamin D 400 IU
100%
100%
Vitamin E 5 IU
100%
50%
Thiamin 0.5 mg
100%
71%
Riboflavin 0.6 mg
100%
75%
Niacin 8 mg
100%
89%
Vitamin B6 0.4 mg
100%
57%
Iron 10 mg
67%
100%
Fluoride 0.25 mg
*
*
* Daily Value (DV) not established

Last reviewed on RxList: 12/8/2004
This monograph has been modified to include the generic and brand name in many instances.

Poly-Vi-Flor Patient Information Including Side Effects

Brand Names: Multi Vita Bets and Fluoride, Poly Vitamin with Fluoride, Poly-Vi-Flor, Soluvite F, Tri-Vi-Flor, Tri-Vitamin with Fluoride

Generic Name: multivitamin with fluoride (Pronunciation: MUL tee VYE ta min with FLOOR ide)

What is multivitamin with fluoride (Poly-Vi-Flor)?

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.

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

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

Multi Vita Bets with 0.5 mg Fl Chew-ACT

square, purple, imprinted with A 031

Multi Vita Bets with Fluoride 0.25 mg Chew-ACT

round, imprinted with A 150

Poly-Vi-Flor 1 mg

diamond, imprinted with M, 474

What are the possible side effects of multivitamin with fluoride?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

This medication may cause the tooth enamel to become discolored. This is a rare side effect that has occurred mainly with large doses or long-term use of multivitamin with fluoride. Stop using this medication and call your dentist or doctor at once if you notice any change in the appearance of your teeth.

Less serious side effects may include:

  • stomach upset;
  • headache; or
  • weakness.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Read the Poly-Vi-Flor (multivitamin, iron and fluoride) Side Effects Center for a complete guide to possible side effects »

What is the most important information I should know about multivitamin with fluoride?

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

Do not use this medicine without the advice of a doctor. Multivitamin 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.

Be sure that a child using this medicine is not taking in extra amounts of fluoride by swallowing toothpaste, or drinking water from sources that contain adequate levels of fluoride.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may cause your body to absorb less of the multivitamin with fluoride.

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

Side Effects Centers

Poly-Vi-Flor Patient Information including How Should I Take

What should I discuss with my healthcare provider before taking multivitamin with fluoride?

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

Do not use this medicine without the advice of a doctor. Multivitamin 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.

FDA pregnancy category C. It is not know if multivitamin with fluoride it harmful to an unborn baby. Before taking this medication, tell your doctor if you are pregnant or plan to become pregnant during treatment.

Multivitamin with fluoride can pass into breast milk and may harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

How should I take multivitamin with fluoride?

Use this medication as directed on the label, or as your doctor has prescribed. Do not use the medication in larger amounts or for longer than recommended.

Take each dose of this medicine with a full glass of water.

The chewable tablet must be chewed or allowed to dissolve in the mouth before swallowing it. You may also allow the tablet to dissolve in drinking water, fruit juice, or infant formula (but not milk or other dairy products).

Do not give a chewable tablet to a child younger than 4 years old. The child may choke on the tablet. Use only liquid forms of this medicine in young children.

Measure the liquid form of multivitamin with fluoride using a special dose-measuring spoon or cup, not a regular table spoon. If you do not have a dose-measuring device, ask your pharmacist where you can get one.

The liquid may also be mixed with water, fruit juice, or infant formula.

It is important to take multivitamin with fluoride regularly to get the most benefit.

Brush teeth regularly, at least two times each day or after meals. This will help prevent tooth discoloration.

Store this medication at room temperature away from moisture and heat. Do not allow the liquid to freeze.

Keep multivitamin with fluoride in the original contain it came in. Storing multivitamin with fluoride in a glass container can ruin the medication.

Side Effects Centers

Poly-Vi-Flor Patient Information including If I Miss a Dose

What happens if I miss a dose?

Take the missed dose as soon as you remember. If it is almost time for your next dose, skip the missed dose and take the medicine at the next regularly scheduled time. Do not take extra medicine to make up the missed dose.

What happens if I overdose?

Seek emergency medical attention if you think you have used too much of this medicine.

Overdose symptoms may include nausea, vomiting, stomach pain, diarrhea, drooling, numbness or tingling, muscle stiffness, or seizures (convulsions).

What should I avoid while taking multivitamin with fluoride?

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

Be sure that a child using this medicine is not taking in extra amounts of fluoride by swallowing toothpaste, or drinking water from sources that contain adequate levels of fluoride.

Do not take this medication with milk, other dairy products, calcium supplements, or antacids that contain calcium. Calcium may cause your body to absorb less of the multivitamin with fluoride.

What other drugs will affect multivitamin with fluoride?

There may be other drugs that can affect multivitamin with fluoride. Tell your doctor about all the prescription and over-the-counter medications you use. This includes vitamins, minerals, herbal products, and drugs prescribed by other doctors. Do not start using a new medication without telling your doctor.

Where can I get more information?

Your pharmacist can provide more information about multivitamin with fluoride.


Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.

Every effort has been made to ensure that the information provided by Cerner Multum, Inc. ('Multum') is accurate, up-to-date, and complete, but no guarantee is made to that effect. Drug information contained herein may be time sensitive. Multum information has been compiled for use by healthcare practitioners and consumers in the United States and therefore Multum does not warrant that uses outside of the United States are appropriate, unless specifically indicated otherwise. Multum's drug information does not endorse drugs, diagnose patients or recommend therapy. Multum's drug information is an informational resource designed to assist licensed healthcare practitioners in caring for their patients and/or to serve consumers viewing this service as a supplement to, and not a substitute for, the expertise, skill, knowledge and judgment of healthcare practitioners. The absence of a warning for a given drug or drug combination in no way should be construed to indicate that the drug or drug combination is safe, effective or appropriate for any given patient. Multum does not assume any responsibility for any aspect of healthcare administered with the aid of information Multum provides. The information contained herein is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. If you have questions about the drugs you are taking, check with your doctor, nurse or pharmacist.

Copyright 1996-2012 Cerner Multum, Inc. Version: 5.02. Revision date: 12/15/2010.

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