Your browser does not support JavaScript! VITAFOL ONE (PRENATAL SUPPLEMENT WITH DHA) CAPSULE, GELATIN COATED [EVERETT LABORATORIES, INC.]
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VITAFOL ONE (prenatal supplement with dha) capsule, gelatin coated
[Everett Laboratories, Inc.]


Category DEA Schedule Marketing Status
HUMAN PRESCRIPTION DRUG LABEL unapproved drug other
NOTE: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.
Drug Label Sections

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.

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

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

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VITAFOL  ONE
prenatal supplement with dha capsule, gelatin coated
Product Information
Product TypeHUMAN PRESCRIPTION DRUG LABELItem Code (Source)NDC:0642-0070
Route of AdministrationORALDEA Schedule    
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Vitamin A (Beta Carotene) Beta Carotene1100 [iU]
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid30 mg
Thiamine Mononitrate (Thiamine ) Thiamine Mononitrate 1.6 mg
Riboflavin (Riboflavin) Riboflavin1.8 mg
Niacin (Niacinamide) Niacinamide15 mg
Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine2.5  mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin.012 mg
Folic Acid (Folic Acid) Folic Acid1 mg
Iodine (Iodine) Iodine0.150 mg
Magnesium (Magnesium Oxide) Magnesium Oxide20 mg
Zinc (Zinc Oxide) Zinc Oxide25 mg
Copper (Cupric Oxide) Cupric Oxide2 mg
Vitamin D (Cholecalciferol) Cholecalciferol1000 [iU]
Omega-3 Fatty Acids (Doconexent) Doconexent200 mg
Vitamin E (Alpha-Tocopherol) Alpha-Tocopherol20 [iU]
Iron (Iron) Iron29 mg
Inactive Ingredients
Ingredient NameStrength
Gelatin 
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
Colorblue (Dark Blue) Scoreno score
ShapeOVAL (size 12 Oval Capsule) Size10mm
FlavorImprint Code EV0070
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:0642-0070-305 in 1 BOX
16 in 1 BLISTER PACK
2NDC:0642-0070-011 in 1 BOX
24 in 1 BLISTER PACK
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other06/13/2011
Labeler - Everett Laboratories, Inc. (071170534)
Establishment
NameAddressID/FEIBusiness Operations
Intergel Pharmaceutical Inc964464114manufacture
Establishment
NameAddressID/FEIBusiness Operations
Nutra-Med Packaging, Inc.022004902pack

Revised: 5/2011
 
Everett Laboratories, Inc.

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