Each blue tablet contains:
Vitamin B 12 (cyanocobalamin) ............................ 12 mcg
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.
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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.
Safety and effectiveness in pediatric patients has not been established.
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.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Usual dosage is one tablet daily, or as prescribed by a physician.
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).
U.S. Patents Pending
KV Pharmaceutical Company for
St. Louis, MO 63045
04-017 © Ther-Rx Corporation