VITAFOL ONE- prenatal supplement with dha capsule, gelatin 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]

Contraindications

Vitafol-One 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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Boxed Warning

WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6.  Keep this product out of the reach of children.  In case of accidental overdose, call a doctor or a Poison Control Center immediately.

WARNINGS/PRECAUTIONS:

Vitafol-One should be used with caution in patients with known sensitivity or allergy to soy.

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 kigney 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.

Iodine should be used with caution in patients with an overactive thyroid.

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.

Consumption of more than 3 grams of omega-3 fatty acids per day from all sources may lead to excessive bleeding.  Supplemental intake of omega-3 fatty acids such as DHA exceeding 2 grams per day is not recommended.

Avoid Overdosage.  Keep out of the reach of children.

Drug Interactions:

Medications for an overactive thyroid (anti-thyroid drugs) used in conjunction with iodine supplementation may lead to hypothyroidism.

Medications for hypertension used in conjunction with iodine supplementation may increase potassium.

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.

Zinc can inhibit the absorption of certain antibiotics; taken at least 2 hours apart to minimize interactions.

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 breast-feeding.

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-One.  However, allergic and idiosyncratic reactions are possible at any dose.  Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.

Dosage and Administration

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

How Supplied

Vitafol-One is available as a dark blue, oval shaped softgel capsule imprinted "EV0070".  Avialable in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (NDC: 0642-0070-30) and as professional samples (NDC: 0642-0070-01).

Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat.

Rx Only

Manufactured for

EVERETT LABORATORIES, INC.

West Orange, NJ 07052

1-877-324-9349

Principal Display Panel

Principal Display Panel

INGREDIENTS AND APPEARANCE

VITAFOL  ONE
prenatal supplement with dha capsule, gelatin coated

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 0642-0070
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Vitamin A (UNII: 81G40H8B0T) (Beta Carotene - UNII:01YAE03M7J)	Beta Carotene	1100 [iU]
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	30 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine - UNII:X66NSO3N35)	Thiamine Mononitrate	1.6 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	1.8 mg
Niacin (UNII: 2679MF687A) (Niacinamide - UNII:25X51I8RD4)	Niacinamide	15 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine	2.5  mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	.012 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4)	Iodine	0.150 mg
Magnesium (UNII: I38ZP9992A) (Magnesium Oxide - UNII:3A3U0GI71G)	Magnesium Oxide	20 mg
Zinc (UNII: J41CSQ7QDS) (Zinc Oxide - UNII:SOI2LOH54Z)	Zinc Oxide	25 mg
Copper (UNII: 789U1901C5) (Cupric Oxide - UNII:V1XJQ704R4)	Cupric Oxide	2 mg
Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41)	Cholecalciferol	1000 [iU]
Omega-3 Fatty Acids (UNII: 71M78END5S) (Doconexent - UNII:ZAD9OKH9JC)	Doconexent	200 mg
Vitamin E (UNII: H4N855PNZ1) (Alpha-Tocopherol - UNII:H4N855PNZ1)	Alpha-Tocopherol	20 [iU]
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	29 mg

Inactive Ingredients
Ingredient Name	Strength
Gelatin (UNII: 2G86QN327L)
Sorbitol (UNII: 506T60A25R)
Glycerin (UNII: PDC6A3C0OX)
Soybean Oil (UNII: 241ATL177A)
Water (UNII: 059QF0KO0R)
Yellow Wax (UNII: 2ZA36H0S2V)
Anhydrous Dibasic Calcium Phosphate (UNII: L11K75P92J)
Lecithin, Soybean (UNII: 1DI56QDM62)
Titanium Dioxide (UNII: 15FIX9V2JP)
Sodium Thiosulfate (UNII: HX1032V43M)
Sunflower Oil (UNII: 3W1JG795YI)
Tocopherol (UNII: R0ZB2556P8)
Ascorbyl palmitate (UNII: QN83US2B0N)
Caramel (UNII: T9D99G2B1R)
FD&C Blue NO. 1 (UNII: H3R47K3TBD)
Corn Oil (UNII: 8470G57WFM)

Product Characteristics
Color	blue (Dark Blue)	Score	no score
Shape	OVAL (size 12 Oval Capsule)	Size	10mm
Flavor		Imprint Code	EV0070
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 0642-0070-30	5 in 1 BOX
1		6 in 1 BLISTER PACK
2	NDC: 0642-0070-01	1 in 1 BOX
2		4 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		06/13/2011

Labeler - Everett Laboratories, Inc. (071170534)

Establishment
Name	Address	ID/FEI	Business Operations
Intergel Pharmaceutical Inc		964464114	manufacture

Establishment
Name	Address	ID/FEI	Business Operations
Nutra-Med Packaging, Inc.		022004902	pack