Label: VITAFOL PLUS- omega-3 fatty acids, niacin, .alpha.-tocopherol, vitamin d, lauric acid, vitamin a, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc, copper, iodine, magnesium, and folic acid capsule, liquid filled

  • DEA Schedule: None
  • Marketing Status: unapproved drug other

DISCLAIMER: 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 Information

Updated April 18, 2012

If you are a consumer or patient please visit this version.


    Rx only



    Each Softgel Capsule Contains:

    Vitamins and Minerals:
    Vitamin A (as beta carotene)1100 IU
    Vitamin C (as ascorbic acid)12 mg
    Vitamin D3 (as cholecalciferol)1000 IU
    Vitamin E (as dl-alpha tocopheryl acetate)10 IU
    Thiamin (Vitamin B1) (as thiamine mononitrate)1.6 mg
    Riboflavin (Vitamin B2)1.8 mg
    Niacin (as nicotinamide)15 mg
    Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
    Folic Acid1 mg
    Vitamin B12 (as cyanocobalamin)12 mcg
    Elemental Iron (as polysaccharide iron complex)27mg
    Iodine (as potassium iodide)200 mcg
    Magnesium (as magnesium oxide)5 mg
    Zinc (as zinc oxide)15 mg
    Copper (as copper oxide)2 mg
    Lauric Acid60 mg
    Omega-3 FATTY ACID
    DHA from Algal (crypthecodinium) Oil200 mg

    Other Ingredients

    Gelatin, Sorbitol, Glycerin, Soybean Oil, USP Purified Water, Yellow Beeswax, Soy Lecithin, FD&C Blue #1, Titanium Dioxide (color), High Oleic Sunflower Oil, Tocopherols, Ascorbyl Palmitate, FD&C Yellow #5, FD&C Red #40.


    Vitafol®-Plus 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®-Plus does not contain fish, fish oils, fish proteins or fish byproducts.


    Vitafol®-Plus 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)

  • BOXED WARNING (What is this?)


    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.


    Vitafol-Plus 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, and 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; take 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 pregnancy and breast-feeding, and the use of all medications and dietary supplements.

    Pediatric Use

    Not for Pediatric Use.


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


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


    Vitafol®-Plus is available as a purple, oval shaped softgel capsule imprinted EV0092. Available in Box of Unit-Dose pack of 30 (5 child resistant blister cards of 6 softgel capsules) (NDC0642-0092-30), and as professional samples (NDC0642-0092-01). Store at room temperature, approximately 15°-30°C (59°-86°F). Avoid excessive heat, moisture and protect from light.


    Rx only

    Manufactured for
    West Orange, NJ 07052

    Patent Pending
    Vitafol® is a trademark of Everett Laboratories, Inc.

    life's DHA is a trademark of DSM.
    U.S. Patent No. 5,492,938; 7,163,811

    (Rev. 03/12)

  • PRINCIPAL DISPLAY PANEL - 30 Capsule Carton

    NDC 0642-0092-30

    Prenatal Supplement with DHA

    Small, All-In-One,
    Once Daily Softgel Capsule


    Actual Size


    life's DHA

    Unit Dose Pack
    30 Softgel Capsules

    Rx only
    Patent Pending

    PRINCIPAL DISPLAY PANEL - 30 Capsule Carton
    omega-3 fatty acids, niacin, .alpha.-tocopherol, vitamin d, lauric acid, vitamin a, ascorbic acid, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, iron, zinc, copper, iodine, magnesium, and folic acid capsule, liquid filled
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0092
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Omega-3 Fatty Acids (UNII: 71M78END5S) (Doconexent - UNII:ZAD9OKH9JC) Omega-3 Fatty Acids200 mg
    Niacin (UNII: 2679MF687A) (Niacinamide - UNII:25X51I8RD4) Niacin15 mg
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol10 [iU]
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D1000 [iU]
    Lauric Acid (UNII: 1160N9NU9U) (Lauric Acid - UNII:1160N9NU9U) Lauric Acid60 mg
    Vitamin A (UNII: 81G40H8B0T) (.Beta.-Carotene - UNII:01YAE03M7J) Vitamin A1100 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid12 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine - UNII:X66NSO3N35) Thiamine Mononitrate1.6 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron27 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc Oxide - UNII:SOI2LOH54Z) Zinc15 mg
    Copper (UNII: 789U1901C5) (Cupric Oxide - UNII:V1XJQ704R4) Copper2 mg
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine200 ug
    Magnesium (UNII: I38ZP9992A) (Magnesium Oxide - UNII:3A3U0GI71G) Magnesium5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
    Inactive Ingredients
    Ingredient NameStrength
    Gelatin (UNII: 2G86QN327L)  
    Sorbitol (UNII: 506T60A25R)  
    Glycerin (UNII: PDC6A3C0OX)  
    Water (UNII: 059QF0KO0R)  
    Yellow Wax (UNII: 2ZA36H0S2V)  
    Soybean Oil (UNII: 241ATL177A)  
    Lecithin, Soybean (UNII: 1DI56QDM62)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    FD&C Yellow No. 5 (UNII: I753WB2F1M)  
    FD&C Red No. 40 (UNII: WZB9127XOA)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Sunflower Oil (UNII: 3W1JG795YI)  
    Tocopherol (UNII: R0ZB2556P8)  
    Ascorbyl Palmitate (UNII: QN83US2B0N)  
    Product Characteristics
    ColorPURPLEScoreno score
    FlavorImprint Code EV0092
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0092-305 in 1 BOX
    16 in 1 BLISTER PACK
    2NDC:0642-0092-011 in 1 BOX
    24 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Labeler - Everett Laboratories, Inc. (071170534)
    NameAddressID/FEIBusiness Operations
    Interge Pharmaceutical, Inc,964464114MANUFACTURE
    NameAddressID/FEIBusiness Operations
    Blispak Acquisition Corporation194902235PACK
    NameAddressID/FEIBusiness Operations
    Nutra-Med Packaging, Inc022004902PACK