Label: VITAFOL OB CAPLET- vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tablet

  • NDC Code(s): 0642-0079-08, 0642-0079-12
  • Packager: Exeltis USA, 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 January 19, 2021

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

  • Rx only

  • COMPOSITION

    Each Caplet contains:

    VITAMINS AND MINERALS:
    Vitamin A (as beta carotene)2700IU
    Vitamin C (as ascorbic acid)70mg
    Vitamin D3 (as cholecalciferol)400IU
    Vitamin E (as dl-alpha tocopheryl acetate)30IU
    Thiamine mononitrate (Vitamin B1)1.6mg
    Riboflavin (Vitamin B2)1.8mg
    Niacin (as niacinamide)18mg
    Vitamin B6 (as pyridoxine hydrochloride)2.5mg
    Folic acid1.0mg
    Vitamin B12 (as cyanocobalamin)12mcg
    Calcium (as calcium carbonate)100mg
    Iron (as ferrous fumarate)65mg
    Magnesium (as magnesium oxide)25mg
    Zinc (as zinc oxide)25mg
    Copper (as copper oxide)2mg

    Other Ingredients: Microcrystalline Cellulose, Gelatin, Sodium Croscarmellose, Stearic Acid, Gum Acacia, Silicon Dioxide, Magnesium Stearate, Modified Food Starch, Sucrose, Silicon Dioxide, Maize Starch, Dicalcium Phosphate, Sodium Ascorbate, Tocopherol Concentrate, Medium Chain Triglycerides, Sorbic Acid, Tricalcium Phosphate, dl-Alpha-Tocopherol. Coating: Hypromellose, Titanium Dioxide, Polydextrose, Triacetin, Hydroxypropyl Cellulose, FD&C Blue #1 / Aluminum Lake, Polyethylene Glycol, FD&C Blue #2 / Aluminum Lake, FD&C Yellow #10 Aluminum Lake.
    Contains: Soy

  • INDICATIONS AND USAGE

    Vitafol®-OB is indicated to provide vitamin, mineral, supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.

  • CONTRAINDICATIONS

    Vitafol®-OB 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 the 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 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.

    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.

    Avoid Overdosage. Keep out of the reach of children.

  • PRECAUTIONS

    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. 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 daily, or as directed by a physician.

  • HOW SUPPLIED

    Vitafol®-OB is available as a light blue caplet, debossed EV0079. Available in Box of Unit-Dose pack of 100 (NDC 0642-0079-12) and as professional samples (0642-0079-03).

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

  • SPL UNCLASSIFIED SECTION

    Rx

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

    1-877-324-9349
    www.exeltisusa.com
    ©2015 Exeltis USA, Inc.

    U.S. PATENT NO. 6,814,983; 7,390,509

    Vitafol® is a trademark of Exeltis USA, Inc.

    REV. October 2015

  • PRINCIPAL DISPLAY PANEL - 100 Caplet Carton

    0642-0079-12

    Vitafol®-OB
    Prenatal Supplement

    10 X 10 UNIT DOSE PACK
    100 CAPLETS

    Rx

    PRINCIPAL DISPLAY PANEL - 100 Caplet Carton
  • INGREDIENTS AND APPEARANCE
    VITAFOL OB   CAPLET
    vitamin a, ascorbic acid, vitamin d, .alpha.-tocopherol, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium, iron, magnesium, zinc, and copper tablet
    Product Information
    Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0642-0079
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A2700 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid70 mg
    Vitamin D (UNII: 9VU1KI44GP) (Cholecalciferol - UNII:1C6V77QF41) Vitamin D400 [iU]
    .Alpha.-Tocopherol (UNII: H4N855PNZ1) (.Alpha.-Tocopherol - UNII:H4N855PNZ1) .Alpha.-Tocopherol30 [iU]
    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 Acid1 mg
    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)  
    .Alpha.-Tocopherol, DL- (UNII: 7QWA1RIO01)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    Polydextrose (UNII: VH2XOU12IE)  
    Triacetin (UNII: XHX3C3X673)  
    HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)  
    FD&C Blue No. 1 (UNII: H3R47K3TBD)  
    Aluminum Oxide (UNII: LMI26O6933)  
    FD&C Blue No. 2 (UNII: L06K8R7DQK)  
    D&C Yellow No. 10 (UNII: 35SW5USQ3G)  
    Product Characteristics
    ColorBLUEScoreno score
    ShapeOVALSize19mm
    FlavorImprint Code EV0079
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0642-0079-084 in 1 CARTON; Type 0: Not a Combination Product12/02/2002
    2NDC:0642-0079-12100 in 1 CARTON; Type 0: Not a Combination Product12/02/2002
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Unapproved drug other12/02/2002
    Labeler - Exeltis USA, Inc. (071170534)