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, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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Updated September 11, 2019
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Iron 106 mg, Sodium Ascorbate 200 mg, Thiamine 10 mg, Riboflavin 6 mg, Pyridoxine 5 mg, 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.
- SPL UNCLASSIFIED SECTION
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
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.
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.
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.
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.
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 AND ADMINISTRATION
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.
- SPL UNCLASSIFIED SECTION
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Lable
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 (Cupric Sulfate) 0.8 mg
CENTURION LABS Rx Only
Net Contents: 30 capsules
PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label
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
Net Contents: 100 capsules
INGREDIENTS AND APPEARANCE
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) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 200 mg THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE 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) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION 10 mg Zinc Sulfate (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION 18.2 mg MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED 6.9 mg Manganese Sulfate (UNII: W00LYS4T26) (MANGANESE CATION (2+) - UNII:H6EP7W5457) MANGANESE CATION (2+) 1.3 mg Cupric Sulfate Anhydrous (UNII: KUW2Q3U1VV) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 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; Type 0: Not a Combination Product 06/14/2009 2 NDC:23359-100-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 06/14/2009 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date Unapproved drug other 06/14/2009 Labeler - Centurion Labs, LLC (016481957) Registrant - Centurion Labs, LLC (016481957) Establishment Name Address ID/FEI Business Operations Contract Pharmacal Corporation 057795122 manufacture(23359-100)