Label: CENTRATEX- iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, niacinamide, calcium pantothenate, zinc sulfate, magnesium sulfate, manganese sulfate, and cupric sulfate anhydrous capsule

  • NDC Code(s): 23359-100-10, 23359-100-30
  • Packager: Centurion Labs
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

Drug Label Information

Updated January 7, 2010

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  • Capsules

    Iron 106 mg, Sodium Ascorbate 200 mg, Thiamine 10 mg, Riboflavin 6 mg, Pyridoxine 5mg, Folic Acid 1 mg, Cyanocobalamin 15 mcg, Niacinamide 30 mg, Pantothenic Acid 10 mg, Zinc 18.2 mg, Magnesium 6.9 mg

    Copper (Copper sulfate) 0.8 mg
    Manganese (Manganese Sulfate) 1.3 mg

    A medical food, for use only under the direction and supervision of a licensed physician.

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  • SPL UNCLASSIFIED SECTION

    RX only

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  • DESCRIPTION

    Active Ingredients (Each capsule)

    Ferrous Fumerate 106 mg(Iron)
    Vitamin C (Sodium Ascorbate) 200 mg
    Vitamin B1 (Thiamine Mononitrate) 10 mg
    Vitamin B2 (Riboflavin) 6 mg
    Vitamin B6 (Pyridoxine HCL) 5 mg
    Folic Acid 1 mg
    Vitamin B12 15 mcg
    Niacinamide 30 mg
    Pantothenic Acid 10 mg
    Zinc (Zinc Sulfate) 18.2 mg
    Magnesium (Magnesium Sulfate) 6.9 mg
    Copper (Copper Sulfate) 0.8 mg
    Manganese (Manganese Sulfate) 1.3 mg

    Inactive Ingredients

    Microcrystalline Cellulose, Silica, Magnesium Stearate, Gelatin Capsule

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  • 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 C deficiency occur together, along with a 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.

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  • CONTRAINDICATIONS

    Centratex is contraindicated in patients with a 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 a contraindication as well.

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  • 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. Iron is toxic and has been shown to cause severe reactions in children including death.

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  • Warning

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.

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  • 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.

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  • 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.

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  • DOSAGE AND ADMINISTRATION

    Adults only: 1 capsule daily between meals, orally. Not recommended in children.

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  • HOW SUPPLIED

    Centratex is supplied as a 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 a tight, light resistant container as defined in the USP/NF with a child resistant closure. Store at room temperature between 15-30 degrees C (59-86 degrees F) Keep in a cool, dry place.

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  • SPL UNCLASSIFIED SECTION

    RX ONLY

    Centurion Labs, LLC
    Birmingham, AL 35243

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  • PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

    NDC 23359-100-10

    Centratex

    Iron (Ferrous Fumarate, anhydrous) 106 mg
    Vitamin C (Sodium Ascorbate) 200 mg
    Vitamin B1 (Thiamine Mononitrate) 10 mg
    Vitamin B2 (Riboflavin) 6 mg
    Vitamin B6 (Pyridoxine HCl) 5 mg
    Vitamin B12 (Cyanocobalamin Concentrate) 15 mcg
    Folic Acid 1 mg
    Niacinamide (Nicotinamide) 30 mg
    Pantothenic Acid (Calcium Pantothenate) 10 mg
    Zinc (Zinc Sulfate) 18.2 mg
    Magnesium (Magnesium Sulfate) 6.9 mg
    Manganese (Manganese Sulfate) 1.3 mg
    Copper (Copper Sulfate) 0.8 mg

    CENTURION LABS
    Rx Only

    Net Contents: 100 capsules

    PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
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  • INGREDIENTS AND APPEARANCE
    CENTRATEX 
    iron, sodium ascorbate, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, folic acid, cyanocobalamin, niacinamide, calcium pantothenate, zinc sulfate, magnesium sulfate, manganese sulfate, and cupric sulfate anhydrous capsule
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:23359-100
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 106 mg
    Sodium Ascorbate (UNII: S033EH8359) (Sodium Cation - UNII:LYR4M0NH37) Sodium Ascorbate 200 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine - UNII:X66NSO3N35) Thiamine Mononitrate 10 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin 6 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride 5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 15 ug
    Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide 30 mg
    Calcium Pantothenate (UNII: 568ET80C3D) (Pantothenic Acid - UNII:19F5HK2737) Calcium Pantothenate 10 mg
    Zinc Sulfate (UNII: 89DS0H96TB) (zinc - UNII:J41CSQ7QDS) Zinc Sulfate 18.2 mg
    Magnesium Sulfate (UNII: DE08037SAB) (Magnesium - UNII:I38ZP9992A) Magnesium Sulfate 6.9 mg
    Manganese Sulfate (UNII: W00LYS4T26) (Manganese - UNII:42Z2K6ZL8P) Manganese Sulfate 1.3 mg
    Cupric Sulfate Anhydrous (UNII: KUW2Q3U1VV) (Copper - UNII:789U1901C5) Cupric Sulfate Anhydrous 0.8 mg
    Inactive Ingredients
    Ingredient Name Strength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Gelatin (UNII: 2G86QN327L)  
    Product Characteristics
    Color BROWN (clear with tan speckled powder) Score no score
    Shape CAPSULE Size 19mm
    Flavor Imprint Code
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:23359-100-10 100 in 1 BOTTLE
    2 NDC:23359-100-30 30 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 06/14/2009
    Labeler - Centurion Labs (806756461)
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