FDA.reportPublic FDA data

Renal Caps

Manufacturer
Cypress Pharmaceutical, Inc. | Accucaps Industries Limited
Effective date
2018-01-04
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
2
Source
full-release
Hydrated at
2026-05-31 20:25:17

Label at a glance#

ProductRenal Caps Dialysis/Stress Vitamin Supplement
Active ingredientASCORBIC ACID, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE
Label structure6 sections

Indications and uses

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.

Dosage and administration

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

Storage and handling

Store at controlled room temperature 15-30 o C (59-86 o F).  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

Label contents#

Full prescribing information#

Description

DESCRIPTION SECTION

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

INDICATIONS & USAGE SECTION

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

PRECAUTIONS SECTION

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

Dosage and Administration

DOSAGE & ADMINISTRATION SECTION

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

Storage

STORAGE AND HANDLING SECTION


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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

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

DailyMed Pharmacologic Classes#

Class, Version, Type table
ClassVersionTypeEffective
ASCORBIC ACID Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
CALCIUM CATION Pharmacologic Class Indexing3Indexing - Pharmacologic Class20230427
CYANOCOBALAMIN Pharmacologic Class Indexing2Indexing - Pharmacologic Class20180813
PYRIDOXINE Pharmacologic Class Indexing1Indexing - Pharmacologic Class20170310

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
cf050ccd-1144-f76a-e00d-e5698d8597d4Product name620250625
bee4fa8d-8d82-423a-a0b5-40a89dd13a99Product name120250618
e0d2eb29-08bd-4bba-90d1-c91c68a38767Product name420250516
30b0ac6e-02aa-0e5c-0d8b-cffdf3a282b2Product name520250304
59361619-24d9-b610-eca6-5a7f25ed5e03Product name520240909
b82b4008-22fd-05f5-6cc6-c0a6e81c65b8Product name220240805
334fe8d2-68fb-4331-a576-420e302ec069Product name720240320
91c62db0-0295-c81c-d10a-0856c259edd6Product name220200428
d32bc2b8-0bb7-2216-87aa-24639646e202Product name320190619
444b3e50-f226-46ef-bfca-2e7035d140cdProduct name120190611
e92765c1-be81-432a-b909-1b10777ec378Product name120190208
7cda52fc-125f-421c-8fea-bc1974370c49Product name220180703
d206bb34-ea65-399d-70d9-834f22dc2c18Product name320170724
5e18e798-5614-cf5c-0185-38b1cb77a093Product name220160822
d5e51f11-ad28-caa4-4b49-4143974782adProduct name120150831
0ca1d589-929b-4b33-bc5b-1d84abdafa6aProduct name120150324
fc363c46-397b-4476-ac0f-70e43e8e4592Product name120150324
0441a8f5-3835-497c-aedd-bc78cba56b2aProduct name120150317
87711080-88eb-65c5-b2dd-bf99e700a372Product name120140508
ec2149b3-5c6d-5344-f757-c86411073075Product name120140508

FDA-Initiated Inactive NDC Indexing#

NDC, Effective, Action table
NDCEffectiveActionDocumentIndexing SPLRelated label
60258-162-012020-01-31C16284748780-19d75b9d0-f451-f424-e053-dadaa90a57ceRenal Caps

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
60258-162-01Renal CapsDialysis/Stress Vitamin Supplement100 in 1 BOTTLECAPSULE, LIQUID FILLED1002

DailyMed Dashboard NDC Coverage#

NDC, Dashboard title, SPL version table
NDCDashboard titleSPL versionValidationDashboard ZIP
60258-162RENAL CAPS DIALYSIS/STRESS VITAMIN SUPPLEMENT (ASCORBIC ACID, THIAMINE MONONITRATE,RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, BIOTIN, CALCIUM PANTOTHENATE, ) CAPSULE, LIQUID FILLED [CYPRESS PHARMACEUTICAL, INC.]2Legacy NDC, 1 package rows20180108_e7a81dfd-7591-442f-b839-4fb2fc79af98.zip

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
60258-162-01EA - Each60258-162a243bf6d-1beb-4ad3-882c-30b7e9d0510112012-07-24

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
BIOTINACTIVE INGREDIENT6SO6U10H041
CALCIUM PANTOTHENATEACTIVE INGREDIENT568ET80C3D1
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
NIACINAMIDEACTIVE INGREDIENT25X51I8RD41
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
BIOTINACTIVE MOIETY6SO6U10H041
CALCIUM PANTOTHENATEACTIVE MOIETY568ET80C3D1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
NIACINAMIDEACTIVE MOIETY25X51I8RD41
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
THIAMINEACTIVE MOIETYX66NSO3N351

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 1 · 16 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
60258-16260258-162-01

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 9 matching rows.

Name, UNII, Kind table
NameUNIIKind
ASCORBIC ACIDPQ6CK8PD0RACTIB
THIAMINE HYDROCHLORIDEM572600E5PACTIR
RIBOFLAVINTLM2976OFRACTIB
NIACINAMIDE25X51I8RD4ACTIB
PYRIDOXINE HYDROCHLORIDE68Y4CF58BVACTIB
FOLIC ACID935E97BOY8ACTIB
CYANOCOBALAMINP6YC3EG204ACTIB
BIOTIN6SO6U10H04ACTIB
CALCIUM PANTOTHENATE568ET80C3DACTIM

Source Document#

Source XML

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
5949216e-a012-4a58-b97f-a2333c0a0800e7a81dfd-7591-442f-b839-4fb2fc79af982018-01-04Exact identifier
spl id: 5949216e-a012-4a58-b97f-a2333c0a0800
spl set id: e7a81dfd-7591-442f-b839-4fb2fc79af98

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.