VITAFOL NANO- cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine tablet, coated

Vitafol by

Drug Labeling and Warnings

Vitafol by is a Prescription medication manufactured, distributed, or labeled by Exeltis USA, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx

COMPOSITION

Amount per Tablet:

VITAMINS AND MINERALS

Vitamin D (as cholecalciferol)	1000		IU
Vitamin B6 (as pyridoxine hydrochloride)	2.5		mg
Folate (as Folic acid USP 0.4 mg and L-methylfolate calcium 0.6 mg, as Metafolin® CAS# 151533-22-1)	1		mg
Vitamin B12 (as cyanocobalamin)	12		mcg
Iron (as ferrous fumarate)	18		mg
Iodine (as potassium iodide)	150		mcg

Other Ingredients

Microcrystalline cellulose, hydroxypropylcellulose, modified food starch, croscarmellose sodium, magnesium stearate, sucrose, silicon dioxide, dibasic calcium phosphate, polyvinyl alcohol, titanium dioxide (as color), polyethylene glycol, talc, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, sucralose, FD&C Blue #2 Aluminum Lake.

USAGE

Vitafol®-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

CONTRAINDICATIONS

Vitafol®-Nano is contraindicated in patients with hypersensitivity to any of its components or color additives.

Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid.

Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver.

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

BOXED WARNING

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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 a Poison Control Center immediately,

WARNINGS/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.

Prolonged use of iron salts may produce iron storage disease.

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 Overdosage. Keep out of the reach of children.

DRUG INTERATIONS

High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate.

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 for pediatric use.

ADVERSE REACTIONS

Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol®-Nano. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

DIRECTIONS FOR USE

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

HOW SUPPLIED

Vitafol®-Nano is available as a light blue, round tablet imprinted with "94" on one side. Available in Box of Unit-Dose pack of 30 (2 child resistant blister cards of 15 tablets), 0642-0094-30 and as professional samples, 0642-0094-03.

Store at Controlled room temperature at 20°-25°C (68°-77°F). Avoid exessive heat, light, moisture and humidity.

SPL UNCLASSIFIED SECTION

Rx

Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932
1-877-324-9349
www.exeltisusa.com
©2017 Exeltis USA, Inc

Metafolin® is a trademark of Merck KGaA, Darmstadt, Germany

U.S. Patent No. 6,441,168B1; 5,997,915; 6,254,904; 6,808,725; 7,172,778 and 7,674,490

Rev. June 2017
0943001-01

PRINCIPAL DISPLAY PANEL - 30 Tablet Dose Pack Carton

0642-0094-30

VITAFOL
Nano

Smallest Prenatal Supplement
with essential nutrients

Unit Dose Pack
30 Tablets

Rx
DIETARY SUPPLEMENT

INGREDIENTS AND APPEARANCE

VITAFOL   NANO
cholecalciferol, pyridoxine hydrochloride, folic acid, levomefolate calcium, cyanocobalamin, iron, and iodine tablet, coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0642-0094
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
CHOLECALCIFEROL (UNII: 1C6V77QF41) (Cholecalciferol - UNII:1C6V77QF41)	CHOLECALCIFEROL	1000 [iU]
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	2.5 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	0.4 mg
Levomefolate Calcium (UNII: A9R10K3F2F) (Levomefolic Acid - UNII:8S95DH25XC)	Levomefolate Calcium	0.6 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	12 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	18 mg
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	150 ug

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
SUCROSE (UNII: C151H8M554)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
SODIUM ASCORBATE (UNII: S033EH8359)
MEDIUM-CHAIN TRIGLYCERIDES (UNII: C9H2L21V7U)
.ALPHA.-TOCOPHEROL, DL- (UNII: 7QWA1RIO01)
SUCRALOSE (UNII: 96K6UQ3ZD4)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)

Product Characteristics
Color	BLUE	Score	no score
Shape	ROUND	Size	6mm
Flavor		Imprint Code	EV0094
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0642-0094-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/14/2014
2	NDC: 0642-0094-03	3 in 1 BLISTER PACK; Type 0: Not a Combination Product	07/14/2014

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
UNAPPROVED DRUG OTHER		07/14/2014

Labeler - Exeltis USA, Inc. (071170534)