Label: PRENATAL VITAMINS PLUS - vitamin a, cholecalciferol, zinc, thiamine mononitrate, ascorbic acid, cyanocobalamin, calcium, copper, folic acid, iron, riboflavin, niacin, .alpha.-tocopherol acetate, dl- and pyridoxine tablet 

  • Label RSS
  • NDC Code(s): 64376-816-01, 64376-816-05
  • Packager: Boca Pharmacal, Inc.
  • Category: HUMAN PRESCRIPTION DRUG LABEL
  • DEA Schedule: None
  • Marketing Status: unapproved drug other

Drug Label Information

Updated 08/12

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

  • BOXED WARNING(What is this?)

    DO NOT USE IF IMPRINTED SAFETY SEAL UNDER CAP IS BROKEN OR MISSING

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  • BOXED WARNING

    WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under six.  Keep this product out of reach of children.  In case of accidental overdose, call a physician or Poison Control Center immediately.

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  • SPL UNCLASSIFIED SECTION

    PreNatal Vitamins Plus
    Rx Only

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  • DESCRIPTION

    Each Tablet Contains: Amount per Tablet % Daily Value
    Vitamin A (Acetate and Beta Carotene) 4000 I.U. 80%
    Vitamin C (Ascorbic Acid) 120mg. 200%
    Vitamin D-3 (Cholecalciferol) 400 I.U. 100%
    Vitamin E (dl-Alpha Tocopheryl Acetate) 22 mg. 73%
    Vitamin B-1 (Thiamine Mononitrate) 1.84 mg. 123%
    Vitamin B-2 (Riboflavin) 3 mg. 176%
    Niacin (Niacinamide) 20 mg 100%
    Vitamin B-6 (Pyridoxine HCl) 10 mg. 500%
    Folic Acid 1 mg. 200%
    Vitamin B-12 (Cyanocobalamin) 12 mcg. 200%
    Calcium (from Calcium Carbonate) 200 mg. 20%
    Iron (Ferrous Fumarate) 27 mg. 150%
    Zinc (Zinc Oxide) 25 mg. 167%
    Copper (Cupric Oxide) 2 mg. 100%

    Other Ingredients: Ascorbyl Palmitate, Citric Acid anhydrous, DL-alpha Tocopherol, Ethylcellulose, FD&C Blue #2 lake, FD&C Red #40 lake, FD&C Yellow #6 lake, Glucose, Gum Acacia, Hypromellose, Magnesium Stearate, Maize Starch, Maltodextrin, Methylcellulose, Microcrystalline Cellulose, Mineral Oil, Mono- and di-glycerides, Polyethylene Glycol, Pregelatinized Corn Starch, Silicon Dioxide, Sorbic Acid, Soy Protein, Stearic Acid, Sucrose, Titanium Dioxide, Tricalcium Phosphate.

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  • INDICATIONS & USAGE

    Indications: To provide vitamin and mineral supplementation throughout pregnancy and during the postnatal period for both the lactating and nonlactating mother. It is also useful for improving nutritional status prior to conception.

    Directions: Before, during and after pregnancy, one tablet daily or as directed by a physician.

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  • CONTRAINDICATIONS

    Contraindications: This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • PRECAUTIONS

    Caution: Folic Acid may partially correct the hematological damage due to Vitamin B-12 deficiency of pernicious anemia while the associated neurological damage progresses.

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  • WARNINGS

    Store at room temperature, USP. Dispense in a well closed light resistant container. KEEP OUT OF THE REACH OF CHILDREN.

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  • REFERENCES

    Manufactured for: Boca Pharmacal, Inc., Coral Springs, FL 33065
    www.bocapharmacal.com    1-800-354-8460   Iss. 06/12

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  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    NDC 64376-816-01
    Bottle of 100 Tablets
    adba00af-figure-01

    [Rev 10]

    NDC 64376-816-05
    Bottle of 500 Tablets
    adba00af-figure-02

    [Rev 7]

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  • INGREDIENTS AND APPEARANCE
    PRENATAL VITAMINS PLUS 
    prenatal vitamins plus tablet
    Product Information
    Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:64376-816
    Route of Administration ORAL DEA Schedule     
    Active Ingredient/Active Moiety
    Ingredient Name Basis of Strength Strength
    VITAMIN A (VITAMIN A) VITAMIN A 4000 [iU]
    CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 400 [iU]
    ZINC (ZINC) ZINC 25 mg
    THIAMINE MONONITRATE (THIAMINE ION) THIAMINE MONONITRATE 1.84 mg
    ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
    CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
    CALCIUM (CALCIUM) CALCIUM 200 mg
    COPPER (COPPER) COPPER 2 mg
    FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
    IRON (IRON) IRON 27 mg
    RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 3 mg
    NIACIN (NIACIN) NIACIN 20 mg
    .ALPHA.-TOCOPHEROL ACETATE, DL- (.ALPHA.-TOCOPHEROL, DL-) .ALPHA.-TOCOPHEROL ACETATE, DL- 22 mg
    PYRIDOXINE (PYRIDOXINE) PYRIDOXINE 10 mg
    Inactive Ingredients
    Ingredient Name Strength
    MINERAL OIL  
    POLYETHYLENE GLYCOLS  
    ASCORBYL PALMITATE  
    ANHYDROUS CITRIC ACID  
    CELLULOSE, MICROCRYSTALLINE  
    ACACIA  
    ETHYLCELLULOSES  
    FD&C BLUE NO. 2  
    FD&C RED NO. 40  
    FD&C YELLOW NO. 6  
    STARCH, CORN  
    SILICON DIOXIDE  
    SORBIC ACID  
    SOY PROTEIN  
    STEARIC ACID  
    SUCROSE  
    TITANIUM DIOXIDE  
    TRICALCIUM PHOSPHATE  
    HYPROMELLOSES  
    MAGNESIUM STEARATE  
    MALTODEXTRIN  
    .ALPHA.-TOCOPHEROL, DL-  
    DEXTROSE  
    METHYLCELLULOSE (15 CPS)  
    GLYCERYL MONOSTEARATE  
    Product Characteristics
    Color WHITE (BEIGE) Score no score
    Shape OVAL (Caplet) Size 19mm
    Flavor Imprint Code BP;816
    Contains     
    Packaging
    # Item Code Package Description Marketing Start Date Marketing End Date
    1 NDC:64376-816-01 100 in 1 BOTTLE
    2 NDC:64376-816-05 500 in 1 BOTTLE
    Marketing Information
    Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
    Unapproved drug other 04/15/2011
    Labeler - Boca Pharmacal, Inc. (170266089)
    Registrant - Boca Pharmacal, Inc. (170266089)
    Establishment
    Name Address ID/FEI Business Operations
    Cispharma Inc. 833171445 MANUFACTURE(64376-816)
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