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Vitafol One

Generic name: vitamin a, ascorbic acid, thiamine mononitrate , riboflavin, niacin, pyridoxine hydrochloride, cyanocobalamin, folic acid, iodine, magnesium , zinc , copper, vitamin d, omega-3 fatty acids, vitamin e and iron
Dosage form: capsule, gelatin coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. Read further information about unapproved drugs.

Rx

0642-0070-30

*
providing 200DHA (docosahexaenoic acid)
COMPOSITION:
Each Softgel Capsule Contains:
VITAMINS AND MINERALS:
Vitamin A (as Vitamin A palmitate) 330 mcg RAE
Vitamin C (as ascorbic acid) 30 mg
Vitamin D3 (as cholecalciferol) 25 mcg
Vitamin E (as dl-alpha tocopheryl acetate) 9 mg
Thiamine mononitrate (Vitamin B1) 1.6 mg
Riboflavin (Vitamin B2) 1.8 mg
Niacin (as niacinamide) 15 mg NE
Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg
Folate (as folic acid) 1700 mcg DFE
Vitamin B12 (as cyanocobalamin) 12 mcg
Elemental Iron (as polysaccharide iron complex) 29 mg
Iodine (as potassium iodide) 150 mcg
Magnesium (as magnesium oxide) 20 mg
Zinc (as zinc oxide) 25 mg
Copper (as copper oxide) 2 mg
Algal oil blend (derived from natural algal oil) 415 mg*

Other Ingredients:

Gelatin (Bovine BSE-free), Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Dicalcium Phosphate, Soy Lecithin, Vegetable Oil, FD&C Blue #1, Titanium Dioxide (color), Sodium Thiosulfate, Caramel (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate. Contains: Soy.

Indications and Usage for Vitafol One

Vitafol-One is indicated to provide vitamin, mineral, and omega-3 fatty acid supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother, including individuals with known allergies to fish. Vitafol-One does not contain fish, fish oils, fish proteins or fish byproducts.

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 B-12).

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

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 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.

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 recommended 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.

Vitafol One Dosage and Administration

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

How is Vitafol One Supplied

Vitafol-One is available as a dark blue, oval shaped softgel capsule imprinted "EV0070". Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules), (0642-0070-30) and as professional samples (0642-0070-03).

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

Rx

Distributed by:
Exeltis USA, Inc.
Florham Park, NJ 07932

1-877-324-9349
www.exeltisusa.com
©2019 Exeltis USA, Inc.

U.S. Patent No. 8,183,227
Vitafol® is a trademark of Exeltis USA, Inc.

Rev. April 2021
0703001-02

PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton

0642-0070-30

VITAFOL
One

Prenatal Supplement with DHA

Unit Dose Pack
30 Softgel Capsules

RX
DIETARY SUPPLEMENT
U.S. PATENTED

VITAFOL ONE
prenatal supplement with dha capsule, gelatin coated
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:0642-0070
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Vitamin A (Vitamin A) Vitamin A 330 ug
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 30 mg
Thiamine Mononitrate (Thiamine Ion) Thiamine 1.6 mg
Riboflavin (Riboflavin) Riboflavin 1.8 mg
Niacin (Niacin) Niacin 15 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine 2.5 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin .012 mg
Folic Acid (Folic Acid) Folic Acid 1700 ug
Iodine (Iodine) Iodine 0.150 mg
Magnesium (Magnesium) Magnesium 20 mg
Zinc (Zinc) Zinc 25 mg
Copper (Copper) Copper 2 mg
Vitamin D (Cholecalciferol) Vitamin D 25 ug
Omega-3 Fatty Acids (Omega-3 Fatty Acids) Omega-3 Fatty Acids 200 mg
.Alpha.-Tocopherol (.Alpha.-Tocopherol) .Alpha.-Tocopherol 9 mg
Iron (Iron) Iron 29 mg
Inactive Ingredients
Ingredient Name Strength
Gelatin, Unspecified
Sorbitol
Glycerin
Soybean Oil
Water
Yellow Wax
Anhydrous Dibasic Calcium Phosphate
Lecithin, Soybean
Titanium Dioxide
Sodium Thiosulfate
Sunflower Oil
Tocopherol
Ascorbyl palmitate
Caramel
FD&C Blue NO. 1
Corn Oil
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
1 NDC:0642-0070-30 5 BLISTER PACK in 1 BOX
1 6 CAPSULE, GELATIN COATED in 1 BLISTER PACK
2 NDC:0642-0070-01 1 BLISTER PACK in 1 BOX
2 4 CAPSULE, GELATIN COATED 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)
Everett Laboratories, Inc.