Premesisrx tablets

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 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 tablets, debossed "Ther-Rx" on one side and "019" on the other side in bottles of 100 tablets (NDC 64011-019-04). Store at controlled room temperature, 15°-30°C (59°-86°F).

P3264-3 02/02

Manufactured by

KV Pharmaceutical Co.

for Ther-Rx Corporation

St. Louis, MO 63045

U.S. Patent No. 6,197,329

PRODUCT PHOTO(S):

NOTE: These photos can be used only for identification by shape, color, and imprint. They do not depict actual or relative size.

The product samples shown here have been supplied by the manufacturer. While every effort has been made to assure accurate reproduction, please remember that any visual identification should be considered preliminary. In cases of poisoning or suspected overdosage, the drug's identity should be verified by chemical analysis.