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PrimaCare AM Capsules, PrimaCare PM Tablets (Ther-Rx)



  • Description
  • Indications and Usage
  • Contraindications
  • Warnings
  • Precautions
  • Adverse Reactions
  • Dosage and Administration
  • How Supplied



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  • DESCRIPTION

    PrimaCare® is a prescription prenatal/ postnatal multivitamin/mineral capsule and tablet combination with essential fatty acids that consists of two dosage forms on each blister card designated as AM and PM, as follows:

    AM dose is a dye-free, white soft gelatin capsule containing the following ingredients:


    Essential Fatty Acids (as OmegaNate™):
    Omega-3 Fatty Acids
    300 mg
    Linoleic Acid
    30 mg
    Linolenic Acid 30 mg

      Vitamins:
    Vitamin D 3 (cholecalciferol) 170 IU
    Vitamin E (dl-alpha-tocopheryl acetate) 30 IU

    Minerals:
    Calcium (calcium carbonate) 150 mg

    PM dose is a dye-free, oval shaped, pink film coated tablet containing the following ingredients:

    Vitamins:
    Biotin 35 mcg
    Folic Acid, USP 1 mg
    Vitamin B 1 (thiamine mononitrate, USP) 3 mg
    Vitamin B 2 (riboflavin, USP) 3.4 mg
    Vitamin B 3 (niacinamide) 20 mg
    Vitamin B 6 (pyridoxine HCl, USP) 50 mg
    Vitamin B 12 (cyanocobalamin) 12 mcg
    Vitamin C (as Ester-C ®) * 100 mg
    Vitamin D 3 (cholecalciferol) 230 IU
      Vitamin K 90 mcg
    Pantothenic Acid 7 mg

    Minerals:
    Calcium (as CalciPure™ calcium carbonate) 250 mg
    Chromium 45 mc
    Copper (cupric oxide) 1.3 mg
    Iron (as MicroMask® ferrous fumarate) 30 mg
    Molybdenum 50 mcg
    Selenium 75 mcg
    Zinc (zinc oxide, USP) 11 mg
    * Ester-C ® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C ® is a licensed trademark of Zila Nutraceuticals, Inc.


    Inactive Ingredients:    Capsule: Natural wax, natural oils, and other ingredients. Dye free. Tablet: Cellulose polymers, flow agents, natural wax, natural oils, flavor, and other ingredients. Dye free.

    INDICATIONS

    PrimaCare® is indicated to provide vitamin/mineral and essential fatty acid supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. It is also useful for improving nutritional status prior to conception.

    CONTRAINDICATIONS

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

    WARNINGS

    Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

    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 poison control center immediately.

     

    PRECAUTIONS

    Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

    PEDIATRIC USE:    Safety and effectiveness in pediatric patients has not been established.

    GERIATRIC USE:    Clinical studies on this product have not been performed to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

    ADVERSE REACTIONS

    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

    DOSAGE AND ADMINISTRATION

    PrimaCare®'s patented Chronometric System™ dosing regimen, consisting of one "AM" dose taken in the morning and one "PM" dose taken at night, should be followed for improved nutrient absorption potential, or as prescribed by a physician.

    HOW SUPPLIED

    PrimaCare® is supplied as a morning and evening oral dosing regimen in child-resistant, unit-dose blister cards of 5 soft gelatin capsules and 5 tablets (6 unit-dose packs of 2 × 5 cards in a 30-day supply unit-of-use dispensing carton) as follows: PrimaCare® capsules are supplied as dye-free, white soft gelatin capsules, imprinted "Ther-Rx 145" on one side in pink ink. PrimaCare® tablets are supplied as dye-free, oval shaped, pink film coated tablets, debossed "Ther-Rx" on one side and "144" with partial bisect on the other side. (NDC 64011-146-28). Store at controlled room temperature 15°-30° C (59°-86° F).

    KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

    P4502      06/04

    Mktd. by Ther-Rx Corp., St. Louis, MO 63044

    U.S. Patent Nos.: 4,822,816; 5,070,085; 5,494,681; 5,945,123; 6,197,329; 6,214,379; 6,228,388; 6,258,846; 6,375,956; 6,488,956; 6,569,857; 6,576,666.

    Other U.S. Patents Pending








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    This page was last modified 30-JUN-07
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