ProFe is a form of the mineral iron. Iron is important for many functions in the body, especially for the transport of oxygen in the blood.

ProFe is used to prevent and to treat iron deficiencies and iron deficiency anemia.

ProFe is not for use as a general dietary supplement in people with normal iron levels.

ProFe may also be used for purposes not listed in this medication guide.

You should not take ProFe if you have hemochromatosis, hemosiderosis, or hemolytic anemia.

Keep ProFe out of the reach of children. An accidental overdose of iron by a child can be fatal.

Use exactly as directed on the label, or as prescribed by your doctor.

Take ProFe on an empty stomach for best results. If stomach upset occurs, take the medicine with food or after a meal.

Measure liquid medicine carefully. Use the dosing syringe provided, or use a medicine dose-measuring device (not a kitchen spoon).

Read and carefully follow any Instructions for Use provided with your medicine. Ask your doctor or pharmacist if you do not understand these instructions.

You will need frequent medical tests.

Do not use ProFe to treat iron deficiency anemia without your doctor's advice. Every person with anemia should remain under the care of a doctor.

Store at room temperature away from moisture and heat.

Keep this medicine out of the reach of children. An accidental overdose of iron can be fatal to a child.

You should not take ProFe if you have:

• hemochromatosis;

• hemosiderosis; or

• hemolytic anemia.

Do not give this medicine to a child without medical advice.

Tell your doctor if you are pregnant or breastfeeding. Your dose needs may be different during pregnancy or while you are nursing.

Take the medicine as soon as you can, but skip the missed dose if it is almost time for your next dose. Do not take two doses at one time.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222. An overdose of ProFe can be fatal, especially to a child.

Overdose symptoms may include decreased energy, fever, vomiting, stomach pain, tarry stools, weak pulse, fast heart rate, or seizure (convulsions).

For at least 2 hours before or 2 hours after you take ProFe, avoid:

• milk or other dairy products;

• high-fiber foods (such as whole grains, raw vegetables, or bran);

• coffee, tea;

• cola, chocolate; or

• energy drinks, or other sources of caffeine.

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

ProFe may cause serious side effects. Call your doctor at once if you have:

• bloody or tarry stools; or

• severe stomach pain or cramps.

Common side effects of ProFe may include:

• constipation, diarrhea;

• nausea, upset stomach;

• black or dark colored stools; or

• temporary staining of the teeth.

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.

Some medicines can make ProFe much less effective when taken at the same time. If you take any of the following medicines, take your this medicine dose 2 hours before or 2 hours after you take the other medicine:

• an antacid;

• an antibiotic;

• medicine to treat Parkinson's disease; or

• thyroid medication.

This list is not complete. Other drugs may affect ProFe, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.