Niferex contains a combination of ascorbic acid and iron polysaccharide. Ascorbic acid is important for the skin and connective tissues, for normal chemical and hormonal production, and for the immune system. Iron polysaccharide 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.

Niferex is a dietary iron supplement, and is used to prevent and to treat iron deficiencies and iron deficiency anemia.

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

Do not take more Niferex than is prescribed for you or than is directed on the package.

Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Niferex may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking this medicine if you take any other prescription or over-the-counter medicines.

Before taking this medicine

If you do not have an iron deficiency, talk to your doctor about the use of Niferex. Generally, ascorbic acid and iron polysaccharide should not be taken chronically by individuals with a normal iron balance.

To make sure you can safely take Niferex, tell your doctor if you have any of these other conditions:

• diabetes;

• hemosiderosis;

• hemolytic anemia;

• hemochromatosis;

• kidney disease or an increased risk of kidney stones;

• if you are on a sodium restricted diet; or

• if you are allergic to sulfites or tartrazine.

It is not known whether Niferex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ascorbic acid and iron polysaccharide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Take Niferex exactly as directed by your doctor, or as directed on the package. Do not take in larger or smaller amounts or for longer than recommended. Follow the directions on your prescription label.

Keep this product out of reach of children. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. In case of accidental overdose, call a doctor or poison control center immediately.

Take this medicine with a full glass of water.

Niferex may decrease the absorption of other medicines. Talk to your doctor and pharmacist before taking this medicine if you take any other prescription or over-the-counter medicines.

This medication can cause unusual results with certain medical tests. Tell any doctor who treats you that you are using Niferex.

Store at room temperature, away from moisture and heat.

If you do not have an iron deficiency, talk to your doctor about the use of Niferex. Generally, ascorbic acid and iron polysaccharide should not be taken chronically by individuals with a normal iron balance.

To make sure you can safely take Niferex, tell your doctor if you have any of these other conditions:

• diabetes;

• hemosiderosis;

• hemolytic anemia;

• hemochromatosis;

• kidney disease or an increased risk of kidney stones;

• if you are on a sodium restricted diet; or

• if you are allergic to sulfites or tartrazine.

It is not known whether Niferex will harm an unborn baby. Tell your doctor if you are pregnant or plan to become pregnant while using this medication.

It is not known whether ascorbic acid and iron polysaccharide passes into breast milk or if it could harm a nursing baby. Do not use this medication without telling your doctor if you are breast-feeding a baby.

Take the missed dose as soon as you remember. Skip the missed dose if it is almost time for your next scheduled dose. Do not take extra medicine to make up the missed dose.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose can cause decreased energy, nausea, vomiting, abdominal pain, tarry stools, weak or rapid pulse, fever, or seizure (convulsions).

Do not take Niferex within 2 hours before or after you take any of the following medicines

• levodopa (Larodopa, Dopar, Sinemet);

• levothyroxine (Synthroid, Levoxyl, others);

• methyldopa (Aldomet);

• penicillamine (Cuprimine);

• antacids (Amphojel, Maalox, Mylanta, Rolaids, Rulox, Tums, and others);

• a tetracycline antibiotic such as demeclocycline (Declomycin), doxycycline (Adoxa, Doryx, Oracea, Vibramycin), minocycline (Dynacin, Minocin, Solodyn, Vectrin), or tetracycline (Brodspec, Panmycin, Sumycin, Tetracap); or

• an antibiotic such as ciprofloxacin (Cipro), ofloxacin (Floxin), norfloxacin (Noroxin), levofloxacin (Levaquin), lomefloxacin (Maxaquin), and others.

Niferex may decrease the absorption of the drugs listed above.

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

Stop using this medication and call your doctor at once if you have a serious side effect such as:

• fever;

• severe lower back pain;

• painful or difficult urination;

• blood in your urine; or

• black or dark stools.

Less serious Niferex side effects may include:

• stomach upset;

• nausea or vomiting;

• diarrhea;

• constipation; 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.

Tell your doctor about all other medicines you use, especially:

• a blood thinner such as warfarin (Coumadin).

• an estrogen such as Premarin, Ogen, Estratest, Vivelle, Climara, Estring, Estrace, and others; or

• an oral birth control pill such as Alesse, Levlen, Ovral, Triphasil, Tri-Levlen, Lo-Ovral, and others.

This list is not complete and other drugs may interact with ascorbic acid and iron polysaccharide. Tell your doctor about all medications you use. This includes prescription, over-the-counter, vitamin, and herbal products. Do not start a new medication without telling your doctor.