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PremesisRx Tablets (Ther-Rx)



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



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  • DESCRIPTION

    Each blue tablet contains

    Vitamin B 6 (as pyridoxine HCl) 75 mg
    Vitamin B 12 (cyanocobalamin) 12 mcg
    Folic Acid, USP 1 mg
    Calcium (as calcium carbonate) 200 mg

    Inactive Ingredients:    Natural waxes, cellulose polymers, FD&C blue No. 1 aluminum lake, D&C yellow No. 10 aluminum lake, flow agents and other ingredients.

    INDICATIONS

    PremesisRx® tablets are indicated to provide vitamin and mineral supplementation prior to and during pregnancy and may be used in conjunction with a physician-prescribed regimen to minimize pregnancy related nausea.

    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.

    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

    Usual dosage is one tablet daily, or as prescribed by a physician.

    HOW SUPPLIED

    PremesisRx® tablets for oral administration are supplied as blue, oval shaped tablets, debossed "Ther-Rx" on one side and "019" on the other side in bottles of 30 tablets (NDC 64011-019-19). Store at controlled room temperature, 15°-30°C (59°-86°F).

    Keep this and all drugs out of the reach of children.

    P4560 07/04

    Manufactured by

    KV Pharmaceutical Co.

    for Ther-Rx Corporation

    St. Louis, MO 63044

    U.S. Patent No. 6,197,329; 6,569,857








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    This page was last modified 30-JUN-07
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