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Centratex Package Insert

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Facts
Status:
Prescription (Rx)
Strength:
106 mg, 200 mg, 10 mg, 6 mg, 5 mg, 1 mg, 15 mcg, 30 mg, 10 mg, 18.2 mg, 6.9 mg, 1.3 mg, 0.8 mg
Drug class:
Active ingredients:
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Source: FDA drug labeling via NLM DailyMed · About this document

Prescribing information (package insert) - Centratex

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 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 (Cupric Sulfate)0.8 mg

CENTURION LABS Rx Only

Net Contents: 30 capsules

About this document

Source: FDA drug labeling via NLM DailyMed · View the label on DailyMed

Revision date stated in the text: August 2017

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The information on this site does not replace the advice of a doctor or pharmacist.

Drug information for Centratex

Rx or OTC
Prescription (Rx)?
  • This drug is available only with a prescription from a licensed healthcare provider.
  • Rx
Drug class Blood Coagulation Factor, Calculi Dissolution Agent, Copper Absorption Inhibitor, Osmotic Laxative, Paramagnetic Contrast Agent, Phosphate Binder, Vitamin B12, Vitamin B6 Analog, Vitamin C
Active ingredients Iron 106 mg, Sodium ascorbate 200 mg, Thiamine mononitrate 10 mg, Riboflavin 6 mg, Pyridoxine hydrochloride 5 mg, Folic acid 1 mg, Cyanocobalamin 15 mcg, Niacinamide 30 mg, Calcium pantothenate 10 mg, Zinc sulfate 18.2 mg, Magnesium sulfate, unspecified 6.9 mg, Manganese sulfate 1.3 mg, Cupric sulfate anhydrous 0.8 mg
Dosage form Capsule
Route Oral
Marketing status not in the current FDA NDC Directory
Company (applicant) Centurion Labs, LLC
FDA approval UNAPPROVED DRUG OTHERUnapproved drug
Manufacturers 1 labelers list this drug on DailyMed
Packages (NDC)
Package
106 mg, 200 mg, 10 mg, 6 mg, 5 mg, 1 mg, 15 mcg, 30 mg, 10 mg, 18.2 mg, 6.9 mg, 1.3 mg, 0.8 mg – 100 in 1 bottle NDC 23359-100-10
106 mg, 200 mg, 10 mg, 6 mg, 5 mg, 1 mg, 15 mcg, 30 mg, 10 mg, 18.2 mg, 6.9 mg, 1.3 mg, 0.8 mg – 30 in 1 bottle NDC 23359-100-30

Source: FDA drug labeling via NLM DailyMed, data as of October 31, 2026. FDA data (DailyMed, Orange Book, Drug Shortages, enforcement reports). Not a substitute for the advice of a doctor or pharmacist.