Floriva

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.

Use exactly as directed on the label, or as prescribed by your doctor. Do not use in larger or smaller amounts or for longer than recommended. 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.

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 multivitamins with fluoride using the dosing syringe provided, or with a special dose-measuring spoon or medicine cup. If you do not have a dose-measuring device, ask your pharmacist for one.

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

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

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.

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

Many multivitamin products also contain minerals such as calcium, magnesium, potassium, and zinc. Minerals (especially taken in large doses) can cause side effects such as tooth staining, increased urination, stomach bleeding, uneven heart rate, confusion, and muscle weakness or limp feeling. Read the label of any multivitamin product you take to make sure you are aware of what it contains.

Store in the original container at room temperature away from moisture and heat. Do not allow the liquid to freeze.

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).

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

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.

• It is used to help growth and good health.
• Fluoride may be in the vitamin to prevent tooth decay.

For all patients taking Floriva:

• Tell all of your child's health care providers that your child is taking this medicine. This includes your child's doctors, nurses, pharmacists, and dentists.
• This medicine may affect certain lab tests. Tell all of your child's health care providers and lab workers that your child takes Floriva.
• Your child's dose may depend on how old your child is. Talk with the doctor if you are not sure how much of this medicine to give to your child.
• Different brands of Floriva may not be for use in children younger than 4 years of age. The chance of choking may be raised. Talk with the doctor if you are not sure if this medicine is right for your child.
• Do not give products that have calcium like dairy products within 2 hours of Floriva.
• Do not give products that have aluminum or magnesium like some antacids within 2 hours of this medicine.
• Purified water may not have fluoride.

If your child is pregnant or breast-feeding a baby:

• Talk with the doctor if your child is pregnant, becomes pregnant, or is breast-feeding a baby. You will need to talk about the benefits and risks of using Floriva.

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your child's doctor or get medical help right away if your child has any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Change in look of teeth or gums.