O-CAL PRENATAL VITAMIN (VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERRO

O-CAL PRENATAL VITAMIN (VITAMIN A, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, THIAMINE MONONITRATE, RIBOFLAVIN, NIACIN, PYRIDOXINE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM, FERRO
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NDC 0813-0202-01
Set ID c78bb534-9297-4442-9cda-76eec6a8872d
Category HUMAN PRESCRIPTION DRUG LABEL
Packager Pharmics, Inc.
Generic Name
Product Class
Product Number
Application Number
  • BOXED WARNING(What is this?)

    Additional 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 poison control center immediately.

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  • SPL UNCLASSIFIED SECTION

    Supplement Facts
    Serving Size 1 Tablet
    Amount Per Serving
    Vitamin A (Beta Carotene) 2500 I.U.
    Vitamin C (Ascorbic Acid) 70 mg
    Vitamin D-3 (Cholecalciferol) 400 I.U.
    Vitamin E (Acetate) 30 I.U.
    Vitamin B-1 (Thiamine Monoitrate) 1.5 mg
    Vitamin B-2 (Riboflavin) 1.6 mg
    Niacin (Niacinamide) 17 mg
    Vitamin B-6 (Pyridoxine HCI) 12 mg
    Folic Acid 1 mg
    Vitamin B-12 (Cyanocobalamin) 12 mcg
    Calcium (Calcium Carbonate) 200 mg
    Iron (Ferrous Fumarate) 15 mg
    Iodine (Potassium Iodide) 150 mcg
    Magnesium (Magnesium Oxide) 100 mg
    Zinc (Zinc Oxide) 15 mg
    Copper (Cupric Sulfate) 2 mg
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  • Other Ingredients

    Microcrystalline Cellulose, Croscarmellose Sodium, Magnesium Stearate, Stearic Acid, Hydroxypropyl Methylcellulose, Titanium Dioxide, Triacetin, Silicon Dioxide.

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  • Dosage

    One tablet daily or as directed by a physician.

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  • Indications

    To provide vitamin and mineral supplementation prior to and through pregnancy and during the postnatal period, for both lactating and non-lactating mothers.

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  • Caution

    Folic Acid in doses above 1 mg may obscure pernicious anemia, in that hematological remission may occur while neurological manifestations remain progressive.

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  • SPL UNCLASSIFIED SECTION

    1 800 456 4138
    www.pharmics.com

    Manufactured by
    National Vitamin Co.
    Casa Grande, AZ 85122

    Distributed by
    Pharmics Inc.
    Salt Lake City, UT 84119

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  • PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label

    NDC 00813-0202-01

    RX ONLY

    HEALTHY
    HAPPY

    O-CAL PRENATAL

    Vitamin & Mineral
    Supplement with Folic Acid

    Gluten Free

    100 tablets

    pharmics INC.

    PRINCIPAL DISPLAY PANEL - 100 Tablet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    O-CAL PRENATAL VITAMIN 
    vitamin a, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, thiamine mononitrate, riboflavin, niacin, pyridoxine, folic acid, cyanocobalamin, calcium, ferrous fumarate, iodine, magnesium, zinc, and copper tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:0813-0202
    Route of Administration ORAL
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A 2500 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) Ascorbic Acid 70 mg
    Cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) Cholecalciferol 400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE 30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE 1.5 mg
    Riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) Riboflavin 1.6 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin 17 mg
    Pyridoxine (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine 12 mg
    Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg
    Cyanocobalamin (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) Cyanocobalamin 12 ug
    Calcium (UNII: SY7Q814VUP) (Calcium - UNII:SY7Q814VUP) Calcium 200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS FUMARATE 15 mg
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine 150 ug
    Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium 100 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc 15 mg
    Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper 2 mg
    Inactive Ingredients
    Ingredient Name Strength
    Cellulose, Microcrystalline (UNII: OP1R32D61U)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    Magnesium Stearate (UNII: 70097M6I30)  
    Stearic Acid (UNII: 4ELV7Z65AP)  
    Hypromelloses (UNII: 3NXW29V3WO)  
    Titanium Dioxide (UNII: 15FIX9V2JP)  
    Triacetin (UNII: XHX3C3X673)  
    Sodium Peroxide (UNII: 3GSN3JCJ5K)  
    Product Characteristics
    Color WHITE Score no score
    Shape OVAL (caplet) Size 19mm
    Flavor Imprint Code 0813;PHARMICS
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:0813-0202-01 100 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    UNAPPROVED DRUG OTHER 01/23/2002
    Labeler - Pharmics, Inc. (058560996)
    Establishment
    Name Address ID/FEI Business Operations
    NATIONAL VITAMIN CO., INC 102098324 MANUFACTURE(0813-0202)
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