ONEvite by NEOMED PHARMACEUTICAL ONEVITE tablet

ONEvite by

Drug Labeling and Warnings

ONEvite by is a Other medication manufactured, distributed, or labeled by NEOMED PHARMACEUTICAL. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Each Tablet Contains:

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

WARNINGS

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.

HEALTH CLAIM

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.

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

ONEVITE 
onevite tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:70898-198
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	125 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	10 ug
THIAMINE HYDROCHLORIDE (UNII: M572600E5P) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE HYDROCHLORIDE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	1.7 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE	12.5 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	1000 ug
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	300 ug
CALCIUM PANTOTHENATE (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737)	PANTOTHENIC ACID	10 mg
VITAMIN A ACETATE (UNII: 3LE3D9D6OY) (VITAMIN A - UNII:81G40H8B0T)	VITAMIN A	1500 ug
VANADYL SULFATE (UNII: 6DU9Y533FA) (VANADIUM - UNII:00J9J9XKDE)	VANADYL SULFATE	200 ug
.ALPHA.-LIPOIC ACID (UNII: 73Y7P0K73Y) (.ALPHA.-LIPOIC ACID - UNII:73Y7P0K73Y)	.ALPHA.-LIPOIC ACID	100 mg
LUTEIN (UNII: X72A60C9MT) (LUTEIN - UNII:X72A60C9MT)	LUTEIN	1 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:70898-198-09	1 in 1 PACKAGE
1		90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		12/01/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	4 mm

Labeler - NEOMED PHARMACEUTICAL (048388130)