Label: 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

  • 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 September 6, 2012

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

View All Sections
  • 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 Acid1 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
  • Other Ingredients

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

  • Dosage

    One tablet daily or as directed by a physician.

  • Indications

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

  • Caution

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

  • 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.

  • 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

  • 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
  • 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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:0813-0202
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    Vitamin A (UNII: 81G40H8B0T) (Vitamin A - UNII:81G40H8B0T) Vitamin A2500 [iU]
    Ascorbic Acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R) Ascorbic Acid70 mg
    Cholecalciferol (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) Cholecalciferol400 [iU]
    .ALPHA.-TOCOPHEROL ACETATE (UNII: 9E8X80D2L0) (.ALPHA.-TOCOPHEROL - UNII:H4N855PNZ1) .ALPHA.-TOCOPHEROL ACETATE30 [iU]
    THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J) THIAMINE MONONITRATE1.5 mg
    Riboflavin (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR) Riboflavin1.6 mg
    Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A) Niacin17 mg
    Pyridoxine (UNII: KV2JZ1BI6Z) (PYRIDOXINE - UNII:KV2JZ1BI6Z) Pyridoxine12 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) Calcium200 mg
    FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS FUMARATE15 mg
    Iodine (UNII: 9679TC07X4) (Iodine - UNII:9679TC07X4) Iodine150 ug
    Magnesium (UNII: I38ZP9992A) (Magnesium - UNII:I38ZP9992A) Magnesium100 mg
    Zinc (UNII: J41CSQ7QDS) (Zinc - UNII:J41CSQ7QDS) Zinc15 mg
    Copper (UNII: 789U1901C5) (Copper - UNII:789U1901C5) Copper2 mg
    Inactive Ingredients
    Ingredient NameStrength
    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
    ColorWHITEScoreno score
    ShapeOVAL (caplet) Size19mm
    FlavorImprint Code 0813;PHARMICS
    Contains    
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NDC:0813-0202-01100 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    UNAPPROVED DRUG OTHER01/23/2002
    Labeler - Pharmics, Inc. (058560996)
    Establishment
    NameAddressID/FEIBusiness Operations
    NATIONAL VITAMIN CO., INC102098324MANUFACTURE(0813-0202)
View All Sections

Find additional resources

(also available in the left menu)

Safety

Boxed Warnings, Report Adverse Events, FDA Safety Recalls, Presence in Breast Milk

Related Resources

Medline Plus, Clinical Trials, PubMed, Biochemical Data Summary

More Info on this Drug

View Labeling Archives, RxNorm, Get Label RSS Feed, View NDC Code(s)NEW!