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

Centratex by

Drug Labeling and Warnings

Centratex by is a Prescription medication manufactured, distributed, or labeled by Centurion Labs, LLC, Contract Pharmacal Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

SPL UNCLASSIFIED SECTION

RX only

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.

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.

SPL UNCLASSIFIED SECTION

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, 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

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

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) (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)