Renal Caps
FDA Label NDC 60258-162

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

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Cypress Pharmaceutical, Inc. for the product Renal Caps (NDC 60258-162). 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 description, indications and usage, precautions, dosage and administration, storage, principal display panel - 100 softgel bottle label, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

Description

Renal Caps are opaque black oval softgels imprinted "C 162".  These softgels provide water-soluble vitamins.  Renal Caps contain the following inactive ingredients: Blue 1 Lake, gelatin, glycerin, lecithin, Red 40 Lake, soybean oil, starch, titanium dioxide, Yellow # 6 Lake, yellow beeswax.

Each softgel contains:

Vitamin C (ascorbic acid)........................100 mg

Thiamine (as thiamine mononitrate)..........1.5 mg

Riboflavin...............................................1.7 mg

Niacin (as niacinamide).............................20 mg

Vitamin B6 (as pyridoxine HCl)...................10 mg

Folate (folic acid).........................................1mg

Vitamin B12 (as cyanocobalamin)...............6 mcg

Biotin....................................................150 mcg

Pantothenic Acid (as calcium pantothenate)..5 mg


Indications And Usage

Renal Caps is indicated in the wasting syndrome of chronic renal failure; uremia and impaired metabolic functions of the kidney.  Renal Caps ia also highly effective as a stress vitamin.

Precautions

Folic acid may mask the symptoms of pernicious anemia in that hematologic remission may occur while neurological manifestations progress.

Dosage And Administration

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

Storage


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

KEEP THIS AND ALL DRUGS OUT OF REACH OF CHILDREN.

Manufactured for Cypress Pharmaceutical, Inc.

Madison, MS  39110

L404 Rev 6/02

Principal Display Panel - 100 Softgel Bottle Label

Product Code 60258-162-01

Renal Caps

Dietary Supplement

CYPRESS
PHARMACEUTICAL, INC.

100 Softgels

Principal Display Panel (100 Softgel Bottle Label)

Principal Display Panel (100 Softgel Bottle Label)

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