Ferrex 150

Dosage and Administration Usual adult dosage is one or two capsules daily, or as directed by a physician or health-care provider. Do not exceed recommended dosage.

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

All substitutions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product.

To report a serious adverse event contact: 1-800-367-3395.

Do not use this product if the inner safety seal under the cap is torn, broken or missing Warning: Reproductive Harm - www.P65Warnings.ca.gov.

Dietary Supplement

Contains FD&C Yellow No. 5 Lake (Tartrazine) as a color additive. (see precautions)

If pregnant, or planning to become pregnant or are currently breast-feeding please contact your physician, or health-care provider before using or continuing use.

These statements have not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent any disease.

Ferrex 150 Polysaccharide-Iron Complex Capsules are a product of ferric iron complexed to a low molecular weight polysaccharide.

INDICATIONS AND USAGE Ferrex 150 may be used for the dietary management of iron deficiencies.

CONTRAINDICATIONS Ferrex 150 is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications in the use of this dietary supplement.

PRECAUTIONS This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

The type of anemia and the underlying cause or causes should be determined before initiating supplementation with Ferrex 150. Since the anemia may be a result of a systematic disturbance, such as a recurrent blood loss, the underlying cause or causes should be corrected if possible.

As with all oral iron preparations, Ferrex 150 should be stored out of the reach of children to protect against accidental iron poisoning.

Patients should not exceed the recommended dosage unless directed by a physician. Patients should be informed that iron products can cause dark or black stools. Since oral iron products interfere with absorption of certain antibiotics, these products should not be taken within two hours of each other. ADVERSE REACTIONS Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stool and abdominal pain. Adverse reactions with iron therapy are usually transient. OVERDOSAGE The clinical cause of acute iron overdose can be variable. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

HOW SUPPLIED Ferrex™ 150 Capsules are supplied as orange/brown capsules, imprinted “B203”. Supplied in bottles of 100 capsules, 51991-203-01.

WARNING: Keep this and all medications out of the reach of children.

Store at 25 degrees C (77 degrees F); excursions permitted to 15 degrees - 30 degrees C (59 degrees - 86 degrees F). See USP Controlled Room Temperature. Protect from light and moisture.