MedPath

Centratex

Centratex Capsules

Approved
Approval ID

4d4d823b-ff2f-4746-9bd7-44def2b81347

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Jan 31, 2024

Manufacturers
FDA

Centurion Labs, LLC

DUNS: 016481957

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, and Cupric Sulfate Anhydrous

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code23359-100
Product Classification
G
Generic Name
Iron, Sodium Ascorbate, Thiamine Mononitrate, Riboflavin, Pyridoxine Hydrochloride, Folic Acid, Cyanocobalamin, Niacinamide, Calcium Pantothenate, Zinc Sulfate, Magnesium Sulfate, Manganese Sulfate, and Cupric Sulfate Anhydrous
Product Specifications
Route of AdministrationORAL
Effective DateJanuary 31, 2024
FDA Product Classification

INGREDIENTS (17)

THIAMINE MONONITRATEActive
Quantity: 10 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
SODIUM ASCORBATEActive
Quantity: 200 mg in 1 1
Code: S033EH8359
Classification: ACTIM
CELLULOSE, MICROCRYSTALLINEInactive
Code: OP1R32D61U
Classification: IACT
SILICON DIOXIDEInactive
Code: ETJ7Z6XBU4
Classification: IACT
MAGNESIUM STEARATEInactive
Code: 70097M6I30
Classification: IACT
GELATINInactive
Code: 2G86QN327L
Classification: IACT
IRONActive
Quantity: 106 mg in 1 1
Code: E1UOL152H7
Classification: ACTIB
RIBOFLAVINActive
Quantity: 6 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
PYRIDOXINE HYDROCHLORIDEActive
Quantity: 5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIB
FOLIC ACIDActive
Quantity: 1 mg in 1 1
Code: 935E97BOY8
Classification: ACTIB
CYANOCOBALAMINActive
Quantity: 15 ug in 1 1
Code: P6YC3EG204
Classification: ACTIB
NIACINAMIDEActive
Quantity: 30 mg in 1 1
Code: 25X51I8RD4
Classification: ACTIB
CALCIUM PANTOTHENATEActive
Quantity: 10 mg in 1 1
Code: 568ET80C3D
Classification: ACTIM
ZINC SULFATEActive
Quantity: 18.2 mg in 1 1
Code: 89DS0H96TB
Classification: ACTIM
MAGNESIUM SULFATE, UNSPECIFIEDActive
Quantity: 6.9 mg in 1 1
Code: DE08037SAB
Classification: ACTIB
MANGANESE SULFATEActive
Quantity: 1.3 mg in 1 1
Code: W00LYS4T26
Classification: ACTIM
CUPRIC SULFATE ANHYDROUSActive
Quantity: 0.8 mg in 1 1
Code: KUW2Q3U1VV
Classification: ACTIM

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/12/2019

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

PRINCIPAL DISPLAY PANEL - 100 Capsule Bottle Label

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/12/2019

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 SECTION

LOINC: 34070-3Updated: 9/12/2019

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.

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/12/2019

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.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/12/2019

Warning

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

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/12/2019

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 9/12/2019

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.

PRECAUTIONS SECTION

LOINC: 42232-9Updated: 9/12/2019

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/12/2019

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 - 30 Capsule Bottle

DESCRIPTION SECTION

LOINC: 34089-3Updated: 1/7/2010

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

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Centratex - FDA Drug Approval Details