WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.
Ferralet® 90 (iron [carbonyl iron, ferrous gluconate] 90 mg, folic acid 1 mg, vitamin B12 [cyanocobalamin] 12 mcg, vitamin C [ascorbic acid] 120 mg, docusate sodium 50 mg) is a prescription iron supplement used to treat low levels of iron in the blood caused by certain types of anemia. Your doctor may prescribe Ferralet® 90 if you have iron-deficiency anemia due to pregnancy, blood loss, or certain metabolic diseases, or if you are recovering from surgery, or do not have enough iron in your diet.
Important Safety Information
You should not use Ferralet® 90 if:
- you are allergic to any of the ingredients
- you have hemolytic anemia, or certain iron overload disorders such hemochromatosis, or hemosiderosis
The safety and effectiveness of Ferralet® 90 has not been studied in children.
Ferralet® 90 is not for everyone. Before you take Ferralet® 90, you should tell your doctor about any medical conditions that you may have, including if you have allergies to medicines, foods, or other substances. If you have certain types of anemia (pernicious anemia, or other types of anemia where your vitamin 12 levels are low), folic acid alone is not enough to treat your condition. Doses of 0.1 mg folic acid per day can hide the symptoms of these anemias, making them difficult to diagnose. Consult with your doctor if this treatment is not right for you.
Iron supplements can interfere with certain medicines, including certain antibiotics and antacids. Tell your doctor about all prescription and over-the-counter medicines, vitamins, minerals, other supplements, and herbal products you use. Do not start a new medication without telling your doctor.
Once you start taking Ferralet® 90, take it 2 hours after meals. Do not exceed the recommended dose. Your doctor will order blood tests periodically during treatment to determine whether your dose of Ferralet® 90 needs to be changed.
Ferralet® 90 contains FD&C Yellow No. 5 (tartrazine), a food coloring additive, which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons, such as those who have allergic reactions or sensitivity to aspirin. The overall rate of FD&C Yellow No. 5 (tartrazine) allergic reactions in the general population is low. Some patients taking folic acid have also experienced allergic reactions. Call your doctor and discontinue use of this product if you develop any unusual symptoms.
The most common side effects associated with iron therapy include irritation of your stomach or bowels, constipation, diarrhea, nausea, vomiting, and dark stools. These side effects are generally temporary, however, check with your doctor if any side effect persists or becomes bothersome.
Ferralet® 90 contains iron. Accidental overdose of iron is a leading cause of fatal poisoning in children under the age of 6 years. Symptoms of overdose can include: stomach pain, metabolic acidosis (when the body has high levels of acid), reduction in urine production, brain damage, coma (loss of consciousness), convulsive seizures, death, dehydration, congestion of blood vessels, liver disease, low blood pressure, drop in body temperature, tiredness, nausea, vomiting, diarrhea, black or tarry stools, vomiting blood, rapid heart rate, high blood sugar, feeling drowsy, abnormal pale or bluish skin color, lack of energy, and shock. In case of accidental overdose, call a doctor or poison control center immediately.
KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN.
To report negative side effects, contact Mission Pharmacal Company at 1-800-298-1087 or the FDA at 1-800-FDA-1088 or http://www.fda.gov/medwatch.
Please click here for full Prescribing Information.