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Renal Caps Prescribing Information

Package insert / product label
Generic name: acid, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin and calcium pantothenate
Dosage form: capsule, liquid filled
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Dec 22, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 is 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

Renal Caps DIALYSIS/STRESS VITAMIN SUPPLEMENT
ascorbic acid, thiamine mononitrate,riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin, calcium pantothenate, capsule, liquid filled
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:60258-162
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 100 mg
THIAMINE HYDROCHLORIDE (Thiamine ION) THIAMINE 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 1.7 mg
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 10 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 6000 ug
BIOTIN (BIOTIN) BIOTIN 150000 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID and CALCIUM CATION) PANTOTHENIC ACID 5 mg
Product Characteristics
Color black (C;162) Score no score
Shape CAPSULE Size 15mm
Flavor Imprint Code C;162
Contains
Packaging
# Item Code Package Description
1 NDC:60258-162-01 100 CAPSULE, LIQUID FILLED in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 10/31/2002
Labeler - Cypress Pharmaceutical, Inc. (790248942)
Registrant - Cypress Pharmaceutical, Inc. (790248942)
Establishment
Name Address ID/FEI Operations
Accucaps Industries Limited 248441727 manufacture(60258-162)
Cypress Pharmaceutical, Inc.

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