Ferrous Sulfate Tablets

GENERIC NAME: FERROUS SULFATE (FER-us SUL-fate)

COMMON USES: This medicine is a mineral used to prevent and treat iron deficiency. It may also be used to treat other conditions as determined by your doctor.

HOW TO USE THIS MEDICINE: Use this medicine exactly as directed on the package, unless instructed differently by your doctor. THIS MEDICINE IS ABSORBED BETTER ON AN EMPTY STOMACH BUT MAY BE TAKEN WITH FOOD if it upsets your stomach. IF YOU ARE ALSO TAKING antacids, a bisphosphonate (eg, alendronate), cephalosporin (eg, cephalexin), methyldopa, penicillamine, quinolone (eg, ciprofloxacin), or tetracycline (eg, minocycline) along with this medicine, you may need to space the doses several hours apart. Ask your doctor or pharmacist how much time is needed between doses of this medicine and your other medicines. CERTAIN FOODS AND DRINKS may decrease the amount of this medicine that works in your body. Ask your doctor or pharmacist how you should take this medicine if you consume whole grain breads or cereal, dairy products, coffee, or tea. TAKE THIS MEDICINE WITH A FULL GLASS OF WATER (8 oz/240 mL). DO NOT LIE DOWN for 30 minutes after taking this medicine. STORE THIS MEDICINE at room temperature, between 59 and 86 degrees F (15 and 30 degrees C), in a tightly-closed container, away from heat and light. IF YOU MISS A DOSE OF THIS MEDICINE, skip the missed dose and go back to your regular dosing schedule. Do not take 2 doses at once.

CAUTIONS: ACCIDENTAL OVERDOSE of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this medicine out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. DO NOT TAKE THIS MEDICINE if you have had an allergic reaction to it or are allergic to any ingredient in this product. Do not take large doses of vitamins (megadoses or megavitamin therapy) unless otherwise directed by your doctor. IT MAY TAKE SEVERAL WEEKS for this medicine to work. Do not stop using this medicine without checking with your doctor. DO NOT EXCEED THE RECOMMENDED DOSE or take this medicine for longer than prescribed without checking with your doctor. BEFORE YOU BEGIN TAKING ANY NEW MEDICINE, either prescription or over-the-counter, check with your doctor or pharmacist. This includes antacid products and calcium supplements. Laboratory and/or medical tests (such as blood tests) may be done while you are taking this medicine to monitor your progress or to check for side effects. KEEP ALL DOCTOR AND LABORATORY APPOINTMENTS while you are taking this medicine. THIS MEDICINE MAY CAUSE FALSE TEST RESULTS with kits used to check for blood in the stool. Check with your doctor if you are using this kind of test kit. FOR WOMEN: IF YOU PLAN ON BECOMING PREGNANT, discuss with your doctor the benefits and risks of using this medicine during pregnancy. This medicine is excreted in breastmilk. IF YOU ARE OR WILL BE BREAST-FEEDING while you are using this medicine, check with your doctor or pharmacist to discuss the risks to your baby.

POSSIBLE SIDE EFFECTS: SIDE EFFECTS that may occur while taking this medicine include nausea, constipation, diarrhea, green stools, stomach discomfort, or loss of appetite. If they continue or are bothersome, check with your doctor. WHILE YOU ARE TAKING THIS MEDICINE, you may notice darkening of bowel movements. This is normal. CHECK WITH YOUR DOCTOR AS SOON AS POSSIBLE if you experience fever, vomiting with continuing sharp stomach pain; black, tarry stools; or blood or streaks of blood in the stool. AN ALLERGIC REACTION to this medicine is unlikely, but seek immediate medical attention if it occurs. Symptoms of an allergic reaction include rash, itching, swelling, dizziness, or trouble breathing. If you notice other effects not listed above, contact your doctor, nurse, or pharmacist. This is not a complete list of all side effects that may occur. If you have questions about side effects, contact your healthcare provider. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

BEFORE USING THIS MEDICINE: ACCIDENTAL OVERDOSE of iron-containing products is a leading cause of fatal poisoning in children under 6 years of age. Keep this medicine out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Some medicines or medical conditions may interact with this medicine. INFORM YOUR DOCTOR OR PHARMACIST of all prescription and over-the-counter medicine that you are taking. ADDITIONAL MONITORING OF YOUR DOSE OR CONDITION may be needed if you are taking tetracycline antibiotics (such as doxycycline), quinolone antibiotics (such as ciprofloxacin or levofloxacin), chloramphenicols, levodopa, methyldopa, mycophenolate, penicillamine, or thyroid hormones. Inform your doctor of any other medical conditions including alcohol abuse, stomach ulcers, colitis or other problems with your intestine, kidney infection or other kidney problems, liver problems, certain blood problems (such as porphyria, hemolytic anemia, or thalassemia), multiple blood transfusions, allergies, pregnancy, or breast-feeding. DO NOT USE THIS MEDICINE if you already have excess levels of iron in your blood. Contact your doctor or pharmacist if you have any questions or concerns about using this medicine.

OVERDOSE: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. If overdose is suspected, contact your local poison control center or emergency room immediately. Symptoms of overdose may include unusual drowsiness or tiredness; blue or unusually pale skin; severe or persistent nausea and/or vomiting; severe or persistent stomach pain; tarry stools; weak, fast heartbeat; seizures and loss of consciousness.

ADDITIONAL INFORMATION: Follow the dietary plan provided by your doctor. DO NOT SHARE THIS MEDICINE with others for whom it was not prescribed. DO NOT USE THIS MEDICINE for other health conditions. KEEP THIS MEDICINE out of the reach of children and pets. IF USING THIS MEDICINE FOR AN EXTENDED PERIOD OF TIME, obtain refills before your supply runs out.

The information in this monograph is not intended to cover all possible uses, directions, precautions, drug interactions, or adverse effects. This information is generalized and is not intended as specific medical advice. If you have questions about the medicines you are taking or would like more information, check with your doctor, pharmacist, or nurse.