PremesisRx Tablets (Ther-Rx)

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DESCRIPTION

Each blue tablet contains

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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