Poly-Vi-Flor

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.

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.

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.

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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.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222, especially if a child has accidentally swallowed this medicine.

An overdose of vitamins A, D, E, or K can cause serious or life-threatening side effects. Iron and other minerals contained in a multivitamin can also cause serious overdose symptoms.

Overdose symptoms may include severe stomach pain, vomiting, bloody diarrhea, coughing up blood, constipation, loss of appetite, hair loss, peeling skin, warmth or tingly feeling, changes in menstrual periods, weight loss, severe headache, muscle or joint pain, severe back pain, blood in your urine or stools, black and tarry stools, pale skin, easy bruising or bleeding, weakness, shallow breathing, weak and rapid pulse, pale skin, blue lips, and seizure (convulsions).

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.

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.

When taken as directed, multivitamins are not expected to cause serious side effects.

Fluoride 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 multivitamins with fluoride. Stop using this medicine and call your dentist or doctor at once if you notice any change in the appearance of your teeth.

Common side effects may include:

• upset stomach;

• 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.

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 Poly-Vi-Flor may not be reported. Always consult your doctor or healthcare specialist for medical advice. You may also report side effects to the FDA.