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Nephrocaps Prescribing Information

Package insert / product label
Generic name: ascorbic acid, thiamine, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, biotin and pantothenic acid
Dosage form: capsule, liquid filled
Drug class: Vitamin and mineral combinations

Medically reviewed by Drugs.com. Last updated on Mar 24, 2023.

Nephrocaps Description

Nephrocaps® are opaque black oval softgels imprinted “n”. These softgels provide water-soluble vitamins.

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).....1 mg

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

Biotin.....150 mcg

Pantothenic Acid (as calcium pantothenate)………..5 mg

Indications and Usage for Nephrocaps

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 is 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.

Nephrocaps Dosage and Administration

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

Storage and Handling

Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F). Keep container tightly closed and protected from heat and moisture.

To report a serious adverse event or obtain product information contact 1-800-343-9497.

Keep out of reach of children.

How is Nephrocaps supplied

Nephrocaps® (Dialysis/Stress Vitamin Supplement) are supplied in bottles with 30 (NDC 0187-5268-01), 90 (NDC 0187-5268-02), or 5 (NDC 0187-5268-03) softgels.

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL

NDC 0187-5268-02

Rx Only

NEPHROCAPS®
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 B-6 10 mg, Vitamin B-12 6 mcg, pantothenic acid 5 mg and biotin 150 mcg.

90 SOFTGELS

Valeant Pharmaceuticals North America LLC

Lot No.

Exp. Date

L786-1 Rev.0212


Principal Display Panel - Bottle Label, 90 Softgels

Bottle Label - 90 Softgels

NEPHROCAPS
ascorbic acid, folic acid, niacin, thiamine, riboflavin, pyridoxine, cyanocobalamin, pantothenic acid, biotin capsule, liquid filled
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0187-5268
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID100 mg
THIAMINE (UNII: X66NSO3N35) (THIAMINE - UNII:X66NSO3N35) THIAMINE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACIN (UNII: 2679MF687A) (NIACIN - UNII:2679MF687A) NIACIN20 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE10 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN6 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN150 ug
PANTOTHENIC ACID (UNII: 19F5HK2737) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID5 mg
Product Characteristics
ColorBLACK (White imprint) Scoreno score
ShapeCAPSULE (Oval) Size13mm
FlavorImprint Coden
Contains
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0187-5268-0290 in 1 BOTTLE
2NDC:0187-5268-0130 in 1 BOTTLE
3NDC:0187-5268-0312 in 1 TRAY
35 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
Unapproved drug other06/18/2012
Labeler - Valeant Pharmaceuticals North America LLC (042230623)
Establishment
NameAddressID/FEIBusiness Operations
Catalent Pharma Solutions LLC051762268MANUFACTURE

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