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 
Centurion Labs, LLC

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.

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Centratex
Capsules

Capsules

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.

RX only

DESCRIPTION

Active Ingredients (Each capsule)

Ferrous Fumerate106 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 Acid1 mg
Vitamin B1215 mcg
Niacinamide30 mg
Pantothenic Acid10 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.

DOSAGE AND ADMINISTRATION

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

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.

RX ONLY

Centurion Labs, LLC
Birmingham, AL 35243

Rev. 8/17

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Lable

NDC 23359-100-30

Centratex

Iron (Ferrous Fumarate, anhydrous106 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 - 30 Capsule Bottle

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 Acid1 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
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:23359-100
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7) IRON106 mg
Sodium Ascorbate (UNII: S033EH8359) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID200 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE10 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin6 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin15 ug
Niacinamide (UNII: 25X51I8RD4) (Niacinamide - UNII:25X51I8RD4) Niacinamide30 mg
Calcium Pantothenate (UNII: 568ET80C3D) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION10 mg
Zinc Sulfate (UNII: 89DS0H96TB) (ZINC CATION - UNII:13S1S8SF37) ZINC CATION18.2 mg
MAGNESIUM SULFATE, UNSPECIFIED (UNII: DE08037SAB) (MAGNESIUM CATION - UNII:T6V3LHY838) MAGNESIUM SULFATE, UNSPECIFIED6.9 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 CATION0.8 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
GELATIN (UNII: 2G86QN327L)  
Product Characteristics
ColorBROWN (clear with tan speckled powder) Scoreno score
ShapeCAPSULESize19mm
FlavorImprint Code
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:23359-100-10100 in 1 BOTTLE; Type 0: Not a Combination Product06/14/2009
2NDC:23359-100-3030 in 1 BOTTLE; Type 0: Not a Combination Product06/14/2009
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/14/2009
Labeler - Centurion Labs, LLC (016481957)
Registrant - Centurion Labs, LLC (016481957)
Establishment
NameAddressID/FEIBusiness Operations
Contract Pharmacal Corporation057795122manufacture(23359-100)

Revised: 9/2019
Document Id: ab46d4b9-f3c3-4e86-9810-8b85cb8cf8ac
Set id: 4d4d823b-ff2f-4746-9bd7-44def2b81347
Version: 2
Effective Time: 20190911
 
Centurion Labs, LLC