Myhephron
FDA Label NDC 58607-185

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Martin Ekwealor Pharmaceu for the product Myhephron (NDC 58607-185). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding supplemental factsserving size: 1 capsule daily, description:, indications and usage:, other ingredients:, precautions:, dosage and administration:, storage:, keep this and all drugs out of the reach of children., and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Supplemental Factsserving Size: 1 Capsule Daily

Each capsule contains:

                                                            Amount Per Serving

Vitamin C (ascorbic acid)                           100 mg

Folate (as Vitamin B9)                                  1 mg

Niacin (as Vitamin B3)                                 20 mg

Thiamine (as Vitamin B1)                            1.5 mg

Riboflavin (as Vitamin B2)                           1.7 mg

Pyridoxine HCL (as Vitamin B6)                    10 mg

Cyanocobalamin (as Vitamin B12)                 6 mcg

Pantothenic Acid (as Vitamin B5)                   5 mg

Biotin (as Vitamin B7)                              150 mcg

Description:

Mynephron capsules are opaque black capsules imprinted with "ME 185". Mynephron capsules are formulated with water-soluble vitamins intended to replace specific vitamin loss during dialysis.

Indications And Usage:

Mynephron capsule is indicated in the wasting syndrome of chronic renal failure, uremia and impaired metabolic functions of the kidney, and to maintain levels when the dietary intake of vitamins is inadequate or excretion (loss) is excessive. Mynephron is also highly effective as a stress vitamin.

Other Ingredients:

FD&C Blue 1 Lake, FD&C Red 40 Lake, Gelatin, Sodium Lauryl Sulfate, Maltodextrin.

Precautions:

Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestions remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.

Dosage And Administration:

One capsule daily, or as directed by a physician. If on dialysis, take after treatment.

Storage:

Store at room temperature 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.

Keep This And All Drugs Out Of The Reach Of Children.

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Mynephron Product Label

M.E.

PHARMACEUTICALS, INC.

​​58607-185-10

Mynephron™

CAPSULES

Dialysis and Stress Vitamin Supplement

100 Capsules

Rx Only

M.E. Pharmaeuticals, Inc.

Richmond, IN 47374 USA

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