Centratex

Generic Name: vitamins and minerals
Dosage Form: capsule

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.

Centratex
Capsules

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.

RX only

Centratex 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

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.

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.

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.

Warning

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

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.

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.

Centratex Dosage and Administration

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

How is Centratex 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.

RX ONLY

Centurion Labs, LLC
Birmingham, AL 35243

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

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 LABEL Item Code (Source) NDC:23359-100
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Iron (Iron) Iron 106 mg
Sodium Ascorbate (Sodium Cation) Sodium Ascorbate 200 mg
Thiamine Mononitrate (Thiamine) Thiamine Mononitrate 10 mg
Riboflavin (Riboflavin) Riboflavin 6 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 5 mg
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 15 ug
Niacinamide (Niacinamide) Niacinamide 30 mg
Calcium Pantothenate (Pantothenic Acid) Calcium Pantothenate 10 mg
Zinc Sulfate (zinc) Zinc Sulfate 18.2 mg
Magnesium Sulfate (Magnesium) Magnesium Sulfate 6.9 mg
Manganese Sulfate (Manganese) Manganese Sulfate 1.3 mg
Cupric Sulfate Anhydrous (Copper) Cupric Sulfate Anhydrous 0.8 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Silicon Dioxide  
Magnesium Stearate  
Gelatin  
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
1 NDC:23359-100-10 100 CAPSULE (TABLET) in 1 BOTTLE
2 NDC:23359-100-30 30 CAPSULE (TABLET) 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)
Revised: 01/2010
 
Centurion Labs



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