Fluoride; Vitamin D Liquid (Drops)

What is this medication?

FLUORIDE; VITAMIN D (FLOOR ide; VAHY tuh min D) prevents and treats low fluoride and vitamin D levels in your body. It may also be used to prevent tooth decay or cavities. Fluoride works by making your teeth stronger. Vitamin D works by increasing the amount of calcium absorbed by your body. Fluoride and vitamin D are minerals that play an important role in the health of your teeth and bones.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Floriva

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Chronic diseases
• Drinking water that has fluoride
• Kidney disease
• Liver disease
• An unusual or allergic reaction to fluoride, vitamin D, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

Take this medication by mouth. Take it as directed on the prescription label at the same time every day. Shake well before using. Use a specially marked oral syringe, spoon, or dropper to measure each dose. Ask your pharmacist if you do not have one. Household spoons are not accurate. You can mix the drops with cereal, fruit juice, or other food prior to taking. Do not mix them in milk or formula. Keep taking unless your care team tells you to stop.

Take products with aluminum, magnesium, or calcium in them at a different time of day than this medication. Take this medication at least 2 hours before or after these products.

Talk to your care team about the use of this medication in children. While this medication may be prescribed for children as young as 6 months for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

If you miss a dose, take it as soon as you can. If it is almost time for your next dose, take only that dose. Do not take double or extra doses.

What may interact with this medication?

• Antacids, vitamins, or other products that contain aluminum, calcium, or magnesium

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Visit your care team for regular checks on your progress.

Do not take this supplement unless you are sure you need extra fluoride. Ask your care team for advice, especially if you move to a new area where the amount of fluoride may be different.

Dietary supplements are not regulated like medications. Rigid quality control standards are not required. The purity and strength of the product can vary. This product is not meant to diagnose, treat, cure, or prevent any disease.

The Food and Drug Administration suggests the following to help you protect yourself:

• Read the product labels. Follow the directions on the label.
• Natural does not mean it is safe for humans.
• Use products that include "USP" after the ingredient name. This means that the standards of the US Pharmacopoeia were followed.
• Products made or sold by a nationally known food or drug company are more likely to be made under tight controls. You can write to the company about how the product was made.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Change in tooth color
• Fluoride toxicity—severe stomach pain, nausea, vomiting, unusual weakness or fatigue
• High calcium level—increased thirst or amount of urine, nausea, vomiting, confusion, unusual weakness or fatigue, bone pain

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Constipation
• Loss of appetite
• Nausea

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

Keep out of the reach of children and pets.

Store at room temperature between 15 and 30 degrees C (59 and 86 degrees F). Get rid of any unused medication after the expiration date.

To get rid of medications that are no longer needed or have expired:

• Take the medication to a medication take-back program. Check with your pharmacy or law enforcement to find a location.
• If you cannot return the medication, check the label or package insert to see if the medication should be thrown out in the garbage or flushed down the toilet. If you are not sure, ask your care team. If it is safe to put it in the trash, pour the medication out of the container. Mix the medication with cat litter, dirt, coffee grounds, or other unwanted substance. Seal the mixture in the bag or container. Put in the trash.

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.