ONEVITE- onevite tablet 
NEOMED PHARMACEUTICAL

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Multivitamin and Mineral Supplement
Rx only

Each Tablet Contains:

tab1

Other Ingredients: Di calcium phosphate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, titanium dioxide, PEG 8000, magnesium stearate, talc, HPMC E15 & HPMC E5/E6

INDICATIONS AND USAGE

ONEvite Tablets is an orally administered prescription vitamin supplement specifically formulated for the clinical dietary management of patients with unique nutritional needs requiring, increased folate levels and nutritional supplementation in physiologically stressful conditions. As well as for maintenance of good health and beneficial in maintaining overall skin health, also help maintain healthy blood sugar levels and help promote nerve health and function including normal vision.

CONTRAINDICATIONS

ONEvite Tablets is contraindicated in patients with hypersensitivity to any of its components.    Folic Acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (Vitamin B12).

WARNING/PRECAUTIONS

Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur.

Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive.

The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency.

Avoid Over dosage. Keep out of the reach of children.

Drug Interactions

High doses of folic acid may result in decreased serum levels of anticonvulsant drugs.

Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones.

Consult appropriate references for additional specific vitamin-drug interactions.

Information for Patients

Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding.

Pediatric Use

Not recommended for pediatric use.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at levels substantially higher than those in ONEvite Tablets

DOSAGE AND ADMINISTRATION

ONEvite Tablets is a white film coating with caplet shape.

One tablet daily or as directed by a physician.

HOW SUPPLIED

ONEvite Tablets available 90 tablets per bottle,

70898-198-09

Store at room temperature 15°-30°C (59°-86°F). Avoid excessive heat and moisture.

To report a serious adverse event or obtain product information, call 631-524-5758

Manufactured for:

Neomed Pharmaceutical

Brentwood, NY 11717

www.neomedpharmaceutical.com

MADE IN USA

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.

image description

ONEVITE 
onevite tablet
Product Information
Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:70898-198
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL10 ug
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE HYDROCHLORIDE1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) RIBOFLAVIN1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE20 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN1000 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN300 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737) PANTOTHENIC ACID10 mg
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T) VITAMIN A1500 ug
VANADYL SULFATE (UNII: 6DU9Y533FA) (VANADIUM - UNII:00J9J9XKDE) VANADYL SULFATE200 ug
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y) .ALPHA.-LIPOIC ACID100 mg
LUTEIN (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT) LUTEIN1 mg
Inactive Ingredients
Ingredient NameStrength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS (UNII: L11K75P92J)  
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
STEARIC ACID (UNII: 4ELV7Z65AP)  
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
POLYETHYLENE GLYCOL 8000 (UNII: Q662QK8M3B)  
MAGNESIUM STEARATE (UNII: 70097M6I30)  
TALC (UNII: 7SEV7J4R1U)  
HYPROMELLOSES (UNII: 3NXW29V3WO)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:70898-198-091 in 1 PACKAGE
190 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/01/2018
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
scoring1
shape
size (solid drugs)4 mm
Labeler - NEOMED PHARMACEUTICAL (048388130)

Revised: 6/2019
Document Id: 21036221-2c16-4dd5-9966-df3f58535070
Set id: 2d816a12-d0c0-4908-96a6-b3f1959eaf8b
Version: 1
Effective Time: 20190614
 
NEOMED PHARMACEUTICAL