GENERAL PRECAUTIONS SECTION.


General. Folic acid in doses above 0.1 mg 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

GERIATRIC USE SECTION.


GERIATRIC USE. No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly persons may have decreased hepatic, renal, or cardiac function.

HOW SUPPLIED SECTION.


HOW SUPPLIED. Centratex is supplied as natural gelatin capsule with tan speckled powder. Centratex is available in bottles of 100 (NDC 23359-100-10) and bottles of 30 (NDC 23359-100-30) Dispense in tight, light resistant container as defined in the USP/NF with child resistant closure. Store at room temperature between 15-30 degrees (59-86 degrees F) Keep in cool, dry place.

INDICATIONS & USAGE SECTION.


INDICATIONS. For the treatment of anemia due to lack of iron and low folate as in menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for treatment of conditions where iron and vitamin deficiency occur together, along with poor intake or increased need for B-complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in periods of extended recovery.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. Centratex is contraindicated in patients with known hypersensitivity to any of its ingredients. Iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, and hemolytic anemias. Folic acid may obscure signs and symptoms of pernicious anemia and is therefore contraindication as well.

DESCRIPTION SECTION.


DESCRIPTION. Active Ingredients (Each capsule). Ferrous Fumerate106 mg(Iron)Vitamin (Sodium Ascorbate)200 mgVitamin B1 (Thiamine Mononitrate)10 mgVitamin B2 (Riboflavin)6 mgVitamin B6 (Pyridoxine HCL)5 mgFolic Acid1 mgVitamin B1215 mcgNiacinamide30 mgPantothenic Acid10 mgZinc (Zinc Sulfate)18.2 mgMagnesium (Magnesium Sulfate)6.9 mgCopper (Copper Sulfate)0.8 mgManganese (Manganese Sulfate)1.3 mg. Inactive Ingredients. Microcrystalline Cellulose, Silica, Magnesium Stearate, Gelatin Capsule.

ADVERSE REACTIONS SECTION.


ADVERSE REACTION. Allergic sensitizations have been reported following both oral and parenteral administration of folic acid. Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although the absorption of iron is best when taken between meals, occasional G.I. disturbances may be controlled by giving Centratex shortly after meals.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. Adults only: capsule daily between meals, orally. Not recommended in children.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 100 Capsule Bottle Label. NDC 23359-100-10CentratexIron (Ferrous Fumarate, anhydrous)106 mgVitamin (Sodium Ascorbate)200 mgVitamin B1 (Thiamine Mononitrate)10 mgVitamin B2 (Riboflavin)6 mgVitamin B6 (Pyridoxine HCl)5 mgVitamin B12 (Cyanocobalamin Concentrate)15 mcgFolic Acid1 mgNiacinamide (Nicotinamide)30 mgPantothenic Acid (Calcium Pantothenate)10 mgZinc (Zinc Sulfate)18.2 mgMagnesium (Magnesium Sulfate)6.9 mgManganese (Manganese Sulfate)1.3 mgCopper (Copper Sulfate)0.8 mgCENTURION LABS Rx Only Net Contents: 100 capsules. PRINCIPAL DISPLAY PANEL 100 Capsule Bottle Label.

PEDIATRIC USE SECTION.


PEDIATRIC USE. Safety and effectiveness in pediatric patients has not been established.

PRECAUTIONS SECTION.


PRECAUTIONS. General. Folic acid in doses above 0.1 mg 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.. PEDIATRIC USE. Safety and effectiveness in pediatric patients has not been established.. GERIATRIC USE. No clinical studies have been performed in patients over 65 to determine whether older persons respond differently from younger persons. Physicians should consider that elderly persons may have decreased hepatic, renal, or cardiac function.

SPL UNCLASSIFIED SECTION.


Capsules. Iron 106 mg, Sodium Ascorbate 200 mg, Thiamine 10 mg, Riboflavin mg, Pyridoxine mg, Folic Acid mg, Cyanocobalamin 15 mcg, Niacinamide 30 mg, Pantothenic Acid 10 mg, Zinc 18.2 mg, Magnesium 6.9 mgCopper (Copper sulfate)0.8 mgManganese (Manganese Sulfate)1.3 mgA medical food, for use only under the direction and supervision of licensed physician.

WARNINGS SECTION.


Warning. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately. Iron is toxic and has been shown to cause severe reactions in children including death.