Iron in Baked Products

Ferralet® 90 is a prescription iron supplement approved for treating anemias that respond to oral iron therapy. Your doctor may prescribe Ferralet® 90 if you have certain anemias associated with pregnancy, blood loss, or metabolic disease, or if you are recovering from surgery or do not have enough iron in your diet.

Important Safety Information

Ferralet® 90 has not been tested in children. Dosing for elderly patients should begin at the lower end of the dosing range.

Talk to your doctor before taking Ferralet® 90 if you have a known sensitivity to any of its ingredients.

Because some medications may interact with Ferralet® 90, you should tell your doctor about any medications you are taking, including antacids and antibiotics.

Before prescribing iron therapy, your doctor will need to determine the type of anemia you have and identify its underlying causes. You should not take this product if you have been diagnosed with hemolytic anemia or an iron overload disorder such as hemochromatosis or hemosiderosis.

If you have certain forms of anemia associated with vitamin B12 deficiency (i.e. pernicious anemia), the Folic acid contained in Ferralet® 90 is not enough to treat your condition. Doses of more than 0.1 mg Folic acid per day can hide the symptoms of these anemias, so your doctor must rule them out before prescribing this product.

Once you begin iron therapy with Ferralet® 90, take the product 2 hours after meals, and do not exceed the recommended dose.

When taking Ferralet® 90, you may experience temporary side effects such as GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools.

Some patients taking Folic acid have reported allergic reactions. Additionally, Ferralet® 90 contains FD&C Yellow No. 5 (tartrazine), which may cause allergic reactions (including bronchial asthma) in certain susceptible people. Although uncommon, tartrazine sensitivity is often seen in patients who also have aspirin hypersensitivity. Contact your doctor and discontinue use if you develop any unusual symptoms.

Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six. Symptoms of overdose include abdominal pain, metabolic acidosis, decline or absence of urine production, nerve damage, coma, convulsions, death, dehydration, congestion of blood vessels, cirrhosis of the liver, low blood pressure, hypothermia, fatigue, nausea, vomiting, diarrhea, black or tarry stools, vomiting blood, rapid heart rate, high blood sugar, drowsiness, abnormal pale or bluish skin color, lack of energy, seizures, and shock. In case of accidental overdose, call a doctor or poison control center immediately.

To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.