Mynephrocaps
FDA Label NDC 58607-186

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 Pharmaceuticals, Inc. for the product Mynephrocaps (NDC 58607-186). 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 facts, indications and usage:, precautions:, dosage and administration:, storage:, keep out of reach of children., ingredients:, to report any adverse event or obtain product information, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Supplemental Facts

Serving Size 1 Softgel                                                                   Serving Per Container 100

One Softgel Contains:                                                                    Amount Per Serving

Vitamin C (as ascorbic acid)                                                                                 100 mg
Niacin (as niacinamide)                                                                                          20 mg
Vitamin B ( as pyridoxine HCL)                                                                               10 mg
Pantotnenic Acid (as calcium pantothenate)                                                              5 mg
Riboflavin                                                                                                            1.7 mg
Vitamin B1 (as thiamine mononitrate)                                                                     1.5 mg
Folate (as folic acid)                                                                                                1 mg
Biotin                                                                                                                150 mcg
Vitamin B12 ( as cyanocobalamin)                                                                          6 mcg

Indications And Usage:

In the wasting syndrome in chronic renal failure; uremia; impaired metabolic functions of the kidney and to maintain levels when dietary intake of vitamins is inadequate or excretion or loss in excessive.

Also, highly effective as a stress vitamin.

Precautions:

Folic acid may mask the symptoms of pernicious anemia  in that hematologic remission may occur while neurologic manifestations remain progressive.

Dosage And Administration:

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

Storage:

Store at 25° C (77° F), excursions permitted to 15° - 30° C (59- 80° F). Keep container tightly closed and protected from heat and moisture.

Keep Out Of Reach Of Children.

Keep out of reach of children.

Ingredients:

Soybean oil, ascorbic acid, gelatin, glycerin, niacinamide, diabasic calcium phosphate, calcium pantothenate, lecithin, pyridoxineHCL, yellow wax, thiamine monitrate, riboflavin, folic acid, FD and c blue #1, FD and C red #40, FD and C yellow #6, biotin, titanium dioxide and cyanocobalamin.

To Report Any Adverse Event Or Obtain Product Information

To report any adverse event or obtain product information contact 1-866-578-9637

Product Label

58607-186-03

MYNEPHOCAPS

DIALYSIS/STRESS
Vitamin Supplement

Each Softgel Contains: Vitamin C 100 mg, Folate 1 mg, Niacin 20 mg, Thiamine 1.5 mg, Riboflavin 1.7 mg, Vitamin B6 10 mg, Vitamin B12 6 mcg, Pantothenic acid 5 mg, and Biotin 150 mcg

Rx Onlt

100 Softgels

M.E. Pharmaceuticals, Inc.Richmond, IN 47374

Lot No:

Exp Date:

Mepharma Mynephrocaps Label (Mepharma Mynephrocaps)

Mepharma Mynephrocaps Label (Mepharma Mynephrocaps)

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