MedPath

Vitafol

V™ Vitafol-One Prenatal Supplement with DHA

Approved
Approval ID

42a5cafd-a2c0-4ac2-99c9-708642f00716

Product Type

HUMAN PRESCRIPTION DRUG LABEL

Effective Date

Aug 16, 2021

Manufacturers
FDA

Everett Laboratories, Inc.

DUNS: 071170534

Products 1

Detailed information about drug products covered under this FDA approval, including NDC codes, dosage forms, ingredients, and administration routes.

Prenatal Supplement with DHA

Product Details

FDA regulatory identification and product classification information

FDA Identifiers
NDC Product Code0642-0070
Product Classification
G
Generic Name
Prenatal Supplement with DHA
Product Specifications
Route of AdministrationORAL
Effective DateSeptember 1, 2021
FDA Product Classification

INGREDIENTS (32)

Folic AcidActive
Quantity: 1700 ug in 1 1
Code: 935E97BOY8
Classification: ACTIB
MagnesiumActive
Quantity: 20 mg in 1 1
Code: I38ZP9992A
Classification: ACTIB
ZincActive
Quantity: 25 mg in 1 1
Code: J41CSQ7QDS
Classification: ACTIB
SorbitolInactive
Code: 506T60A25R
Classification: IACT
Soybean OilInactive
Code: 241ATL177A
Classification: IACT
Gelatin, UnspecifiedInactive
Code: 2G86QN327L
Classification: IACT
GlycerinInactive
Code: PDC6A3C0OX
Classification: IACT
Yellow WaxInactive
Code: 2ZA36H0S2V
Classification: IACT
WaterInactive
Code: 059QF0KO0R
Classification: IACT
Sodium ThiosulfateInactive
Code: HX1032V43M
Classification: IACT
Anhydrous Dibasic Calcium PhosphateInactive
Code: L11K75P92J
Classification: IACT
Lecithin, SoybeanInactive
Code: 1DI56QDM62
Classification: IACT
Titanium DioxideInactive
Code: 15FIX9V2JP
Classification: IACT
TocopherolInactive
Code: R0ZB2556P8
Classification: IACT
Ascorbyl palmitateInactive
Code: QN83US2B0N
Classification: IACT
IronActive
Quantity: 29 mg in 1 1
Code: E1UOL152H7
Classification: ACTIB
Corn OilInactive
Code: 8470G57WFM
Classification: IACT
CaramelInactive
Code: T9D99G2B1R
Classification: IACT
FD&C Blue NO. 1Inactive
Code: H3R47K3TBD
Classification: IACT
Vitamin AActive
Quantity: 330 ug in 1 1
Code: 81G40H8B0T
Classification: ACTIB
Ascorbic AcidActive
Quantity: 30 mg in 1 1
Code: PQ6CK8PD0R
Classification: ACTIB
Thiamine MononitrateActive
Quantity: 1.6 mg in 1 1
Code: 8K0I04919X
Classification: ACTIR
RiboflavinActive
Quantity: 1.8 mg in 1 1
Code: TLM2976OFR
Classification: ACTIB
NiacinActive
Quantity: 15 mg in 1 1
Code: 2679MF687A
Classification: ACTIB
Pyridoxine HydrochlorideActive
Quantity: 2.5 mg in 1 1
Code: 68Y4CF58BV
Classification: ACTIM
CopperActive
Quantity: 2 mg in 1 1
Code: 789U1901C5
Classification: ACTIB
Vitamin DActive
Quantity: 25 ug in 1 1
Code: 9VU1KI44GP
Classification: ACTIB
Omega-3 Fatty AcidsActive
Quantity: 200 mg in 1 1
Code: 71M78END5S
Classification: ACTIB
CyanocobalaminActive
Quantity: .012 mg in 1 1
Code: P6YC3EG204
Classification: ACTIB
IodineActive
Quantity: 0.150 mg in 1 1
Code: 9679TC07X4
Classification: ACTIB
Sunflower OilInactive
Code: 3W1JG795YI
Classification: IACT
.Alpha.-TocopherolActive
Quantity: 9 mg in 1 1
Code: H4N855PNZ1
Classification: ACTIB

Drug Labeling Information

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

LOINC: 51945-4Updated: 9/1/2021

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

PRINCIPAL DISPLAY PANEL - 30 Capsule Blister Pack Carton

BOXED WARNING SECTION

LOINC: 34066-1Updated: 9/1/2021

WARNING

INDICATIONS & USAGE SECTION

LOINC: 34067-9Updated: 9/1/2021

INDICATIONS AND USAGE

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 SECTION

LOINC: 34070-3Updated: 9/1/2021

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).

ADVERSE REACTIONS SECTION

LOINC: 34084-4Updated: 9/1/2021

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.

SPL UNCLASSIFIED SECTION

LOINC: 42229-5Updated: 9/1/2021

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

DESCRIPTION SECTION

LOINC: 34089-3Updated: 9/1/2021
  • 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.

WARNINGS SECTION

LOINC: 34071-1Updated: 9/1/2021

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.

DOSAGE & ADMINISTRATION SECTION

LOINC: 34068-7Updated: 9/1/2021

DOSAGE AND ADMINISTRATION

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

HOW SUPPLIED SECTION

LOINC: 34069-5Updated: 9/1/2021

HOW 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.

MedPath

Empowering clinical research with data-driven insights and AI-powered tools.

© 2025 MedPath, Inc. All rights reserved.