Vitamins a, c, D with fluoride and iron (By mouth)

Warnings While Using This Medicine

• Do not give more of this medicine to your child than what your child's doctor has ordered or what the label on the bottle recommends. Iron can build up in the body and may cause harm.
• The level of fluoride present in drinking water may differ from one place to another. Before giving this medicine to your child, check with your child's doctor or dentist first if this medicine is really needed. Also check with your child's doctor or dentist if you change infant feeding habits (e.g., breast-feeding to infant formula), drinking water (e.g., city water to nonfluoridated bottled water), or filtering systems (e.g., tap water to filtered tap water).
• Too much fluoride can cause white patches or yellow or brown spots on the teeth. If this happens, stop giving this medicine to your child and call your doctor.
• Your child's doctor or dentist will need to check your child's progress at regular visits. Be sure to keep all appointments.
• Some vitamin and mineral supplements can sometimes make the stool darker and the urine dark yellow. This is normal.

Possible Side Effects While Using This Medicine

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing

Introduction

Ascorbic Acid (as-KORE-bik AS-id), Fluoride (FLOOR-ide), Iron (EYE-urn), Vitamin A (VYE-ta-min A), Vitamin D (VYE-ta-min D)

Supplies your child's body with vitamins and iron when your child is not getting enough vitamins and iron from the daily diet. Fluoride helps in reducing the number of cavities in the teeth. It is also used to make up for the low level of fluoride in children that do not have enough level of fluoride in the water that they drink.

Brand Name(s)

Tri-Vit With Fluoride and Iron

When This Medicine Should Not Be Used

How to Use This Medicine

Liquid, Drop

• Your child's doctor will tell you how much of this medicine to use and how often. Do not give more medicine or give it more often than your child's doctor tells you to.
• This medicine may be dropped directly into the mouth using the specially marked dropper, or mixed with cereal, fruit juice, or other food.

If a dose is missed:

• If your child misses a dose or if you forget to give your child this medicine, give it as soon as you can. If it is almost time for your child's next dose, wait until then to give the medicine and skip the missed dose. Do not give extra medicine to make up for a missed dose.

How to Store and Dispose of This Medicine

• Store the medicine in a closed container at room temperature, away from heat, moisture, and direct light. Keep the contents of the bottle in its original plastic container.
• Ask your pharmacist, doctor, or health caregiver about the best way to dispose of any outdated medicine or medicine no longer needed.
• Keep all medicine away from children and never share your child's medicine with anyone.

Drugs and Foods to Avoid

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• Make sure your child's doctor knows if your child is receiving fluoride from other sources such as other medicines or swallowed toothpaste.

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088