Label: VITAFOL-OB PLUS DHA PRENATAL SUPPLEMENT PLUS DHA- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, copper, and doconexent kit

  • NDC Code(s): 0642-0076-30
  • Packager: Everett Laboratories, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • 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 August 9, 2021

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  • SPL UNCLASSIFIED SECTION

    0642-0076-30

    Prenatal Supplement with DHA

    Rx

  • COMPOSITION

    Each Vitafol®-OB caplet contains:

    *
    (providing 250 mg DHA (docosahexaenoic acid))
    Vitamin A (as beta carotene)810 mcg RAE
    Vitamin C (as ascorbic acid)70 mg
    Vitamin D3 (as cholecalciferol)10 mcg
    Vitamin E (as dl-alpha tocopheryl acetate)13.5 mg
    Thiamine mononitrate (Vitamin B1)1.6 mg
    Riboflavin (Vitamin B2)1.8 mg
    Niacin (as niacinamide)18 mg NE
    Vitamin B6 (as pyridoxine hydrochloride)2.5 mg
    Folate (as folic acid)1700 mcg DFE
    Vitamin B12 (as cyanocobalamin)12 mcg
    Calcium (as calcium carbonate)100 mg
    Iron (as ferrous fumarate)65 mg
    Magnesium (as magnesium oxide)25 mg
    Zinc (as zinc oxide)25 mg
    Copper (as copper oxide)2 mg
    Each DHA softgel capsule contains:486 mg*
    Algal oil blend (derived from Natural Algal Oil)
  • SPL UNCLASSIFIED SECTION

    Other Ingredients in Vitafol®-OB caplet: Microcrystalline Cellulose, hydrolyzed gelatin (pig skin), modified cellulose gum, stearic acid, hydroxypropylmethylcellulose, titanium dioxide (as color), polydextrose, silicon dioxide, gelatin, magnesium stearate, modified food starch, sucrose, maize starch, triacetin, dibasic calcium phosphate, hydroxypropylcellulose, FD&C Blue #1 Aluminum Lake, polyethylene glycol, sodium ascorbate, tocopherol concentrate, FD&C Blue #2 Aluminum Lake, medium chain trglycerides, sorbic acid, tribasic calcium phosphate, sodium benzoate, dl-alpha-tocopherol. Contains: Soy

    Other Ingredients in DHA softgel capsule: Gelatin, Glycerin USP, Water.

  • INDICATIONS AND USAGE

    Vitafol®-OB+DHA 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®-OB+DHA does not contain fish, fish oils, fish proteins or fish byproducts.

  • CONTRAINDICATIONS

    Vitafol®-OB+DHA 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?)

    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

    Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathryroidism 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.

    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

    High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs.

    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 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®-OB+DHA. Allergic reactions have been reported with some forms of gum acacia to include respiratory problems and skin lesions.

  • DOSAGE AND ADMINISTRATION

    Before, during and after pregnancy, one caplet and one soft-gel capsule daily, or as directed by a physician.

  • HOW SUPPLIED

    VITAFOL®-OB+DHA is available as a light blue caplet debossed EV0079 and one amber-colored DHA softgel capsule. Available in Box of Unit-Dose pack of 30 (6 child resistant blister cards of 5 caplets and 5 softgel capsules each), (0642-0076-30) and as professional samples (0642-0076-03).

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

  • SPL UNCLASSIFIED SECTION

    Rx

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

    1-877-324-9349
    www.exeltisusa.com
    ©2021 Exeltis USA, Inc.

    U.S. Patent No. 6,814,983; 7,390,509
    Vitafol® is a trademark of Exeltis USA, Inc.

    Rev. May 2021

    0763001-02

  • PRINCIPAL DISPLAY PANEL - Kit Carton

    0642-0076-30

    Vitafol®-OB+DHA

    Prenatal Supplement with DHA

    SUGAR, LACTOSE, GLUTEN AND IODINE FREE

    New
    Smaller DHA Softgel

    DOES NOT CONTAIN
    FISH OIL

    RX
    Unit Dose Pack
    30 Caplets and 30 Softgel Capsules
    U.S. Patented

    PRINCIPAL DISPLAY PANEL - Kit Carton
  • INGREDIENTS AND APPEARANCE
    VITAFOL-OB PLUS DHA  PRENATAL SUPPLEMENT PLUS DHA
    vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, copper, and doconexent kit
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0076
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0076-301 in 1 CARTON02/16/2007
    Quantity of Parts
    Part #Package QuantityTotal Product Quantity
    Part 11 BOX 30 
    Part 21 BOX 30 
    Part 1 of 2
    VITAFOL-OB 
    vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tablet, coated
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A810 ug
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid70 mg
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D10 ug
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol13.5 mg
    Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J) Thiamine1.6 mg
    Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR) Riboflavin1.8 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin18 mg
    Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z) Pyridoxine Hydrochloride2.5 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1700 ug
    Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin12 ug
    Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium100 mg
    Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron65 mg
    Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium25 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc25 mg
    Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper2 mg
    Inactive Ingredients
    Ingredient NameStrength
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Croscarmellose Sodium (UNII: M28OL1HH48)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    Silicon Dioxide (UNII: ETJ7Z6XBU4)  
    Modified Corn Starch (1-Octenyl Succinic Anhydride) (UNII: 461P5CJN6T)  
    Sucrose (UNII: C151H8M554)  
    Starch, Corn (UNII: O8232NY3SJ)  
    Sodium Ascorbate (UNII: S033EH8359)  
    Tocopherol (UNII: R0ZB2556P8)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Acacia (UNII: 5C5403N26O)  
    POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
    Medium-Chain Triglycerides (UNII: C9H2L21V7U)  
    Sorbic Acid (UNII: X045WJ989B)  
    Tricalcium Phosphate (UNII: K4C08XP666)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Polydextrose (UNII: VH2XOU12IE)  
    Triacetin (UNII: XHX3C3X673)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    FD&C Blue No. 2 (UNII: L06K8R7DQK)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Aluminum Oxide (UNII: LMI26O6933)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code EV;0079
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER02/16/2007
    Part 2 of 2
    DHA 
    doconexent capsule
    Product Information
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT250 mg
    Inactive Ingredients
    Ingredient NameStrength
    GLYCERIN (UNII: PDC6A3C0OX)  
    GELATIN, UNSPECIFIED (UNII: 2G86QN327L)  
    WATER (UNII: 059QF0KO0R)  
    Product Characteristics
    ColorYELLOW (Amber) Scoreno score
    ShapeOVALSize15mm
    FlavorImprint Code
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    130 in 1 BOX; Type 1: Convenience Kit of Co-Package
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT02/16/2007
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other02/16/2007
    Labeler - Everett Laboratories, Inc. (071170534)