NIVA-PLUS- folic acid, vitamin a, ascorbic acid, calcium sulfate, ferrous fumarate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, zinc oxide, and cupric oxide tablet, coated 
Nivagen Pharmaceuticals, Inc.

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Niva-Plus™
Tablets

Rx Only

DESCRIPTION

Niva-Plus™ is an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. Niva-Plus™ is an oval, beige tablet with "N050" debossed on one side.

Supplement Facts
Servings per Bottle:  100
Serving Size: 1 tablet
Each tablet contains:
% DV Adults & Children 4 Years or More
Folic Acid1 mg250%
Vitamin A (Input as vitamin A acetate and beta carotene)4000 IU80%
Vitamin C (ascorbic acid)120 mg200%
Calcium (calcium sulfate)200 mg20%
Iron (ferrous fumarate)27 mg150%
Vitamin D3 (cholecalciferol)400 IU100%
Vitamin E (dl-alpha-tocopheryl acetate)22 IU157%
Vitamin B1 (thiamine mononitrate)1.84 mg123%
Vitamin B2 (riboflavin)3 mg176%
Niacinamide (vitamin B3)20 mg100%
Vitamin B6 (pyridoxine HCl)10 mg500%
Vitamin B12 (cyanocobalamin)12 mcg200%
Zinc (zinc oxide)25 mg167%
Copper (cupric oxide)2 mg100%

Other Ingredients: Microcrystalline Cellulose, Beige Color Coating (Hydroxypropylmethyl Cellulose, Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Yellow #6 Lake, FD&C Blue #2 Lake), Pregelatinized Starch, Croscarmellose Sodium, Di Calcium Phosphate, Magnesium Stearate, Stearic Acid, Fumed Silica, Ascorbyl Palmitate.

INDICATIONS AND USAGE

Niva-Plus™ is indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS

General

Folic acid, when prescribed as a single agent in doses above 0.1 mg daily, may obscure the detection of B12 deficiency (specifically, the administration of folic acid may reverse the hematological manifestations of B12 deficiency, including pernicious anemia, while not addressing the neurological manifestations). Reduced folates may be less likely than folic acid to mask vitamin B12 deficiency. Folate therapy alone is inadequate for the treatment of B12 deficiency.

PATIENT INFORMATION

Niva-Plus™ is a prescription vitamin for the use only under the direction and supervision of a licensed physician.

INTERACTIONS

Pyridoxine hydrochloride should not be given to patients receiving the drug levodopa, because the action of levodopa is antagonized by pyridoxine hydrochloride. However, pyridoxine hydrochloride may be used concurrently in patients receiving a preparation containing both carbidopa and levodopa.

Drugs which may interact with folate include:

ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates - including reduced folates. Paresthesia, somnolence, nausea and headaches have been reported with pyridoxine hydrochloride. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

Ferrous Fumarate

Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and subside with continuation of therapy and physician encouragement. Although, the absorption of iron is best when taken between meals, occasional gastrointestinal disturbances may be controlled giving Niva-Plus™ shortly after meals.

DOSAGE AND ADMINISTRATION

Before, during and after pregnancy, one tablet daily, or as prescribed by a physician.

HOW SUPPLIED

Niva-Plus™ is supplied as:

Bottles of 100 tablets: 75834-050-01

KEEP OUT OF REACH OF CHILDREN

Rx Only

Manufactured for:
Nivagen Pharmaceuticals, Inc., Sacramento, CA 95827
nivagen.com

Rev. 09/14

PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

75834-050-01
Rx Only

Niva-Plus™
Tablets

NIVAGEN
PHARMACEUTICALS

100 TABLETS

Principal Display Panel - 100 Tablet Bottle Label
NIVA-PLUS 
folic acid, vitamin a, ascorbic acid, calcium sulfate, ferrous fumarate, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, cyanocobalamin, zinc oxide, and cupric oxide tablet, coated
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:75834-050
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
VITAMIN A (UNII: 81G40H8B0T) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A4000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID120 mg
CALCIUM SULFATE (UNII: WAT0DDB505) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM SULFATE200 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION27 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-22 [iU]
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE1.84 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN3 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE10 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z) ZINC OXIDE25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION2 mg
Inactive Ingredients
Ingredient NameStrength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
POLYVINYL ALCOHOL (UNII: 532B59J990)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)  
TALC (UNII: 7SEV7J4R1U)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
ALUMINUM OXIDE (UNII: LMI26O6933)  
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
ASCORBYL PALMITATE (UNII: QN83US2B0N)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:75834-050-01100 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT11/24/2014
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)22 mm
imprint
Labeler - Nivagen Pharmaceuticals, Inc. (052032418)

Revised: 3/2015
Document Id: 9155e422-9257-418a-b26b-92a64b2f97f4
Set id: 58754e85-0104-44ec-bb0a-acc64677e329
Version: 1
Effective Time: 20150312
 
Nivagen Pharmaceuticals, Inc.