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PrimaCare One Capsules (Ther-Rx)
- Drugs index
PrimaCare® ONE is a prescription prenatal/postnatal multivitamin/mineral capsule with Essential Fatty Acids. Each purple soft gelatin capsule contains:
OmegaNate Essential Fatty Acids and Precursors:
Inactive Ingredients: Gelatin, vegetable shortening, glycerine, soybean oil, yellow beeswax, lecithin, titanium dioxide, methylparaben, ethylvanillin, D&C Red #33, propylparaben, FD&C Blue #1.
PrimaCare® ONE 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.
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 1.0 mg daily may obscure perni-cious 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.
DOSAGE AND ADMINISTRATION
Usual dosage is one capsule daily, or as prescribed by a physician.
PrimaCare® ONE prenatal/postnatal multivitamin/mineral capsules with essential fatty acids for oral administration are supplied as purple soft gelatin capsules imprinted "Ther-Rx 142" in white ink in bottles of 30 soft gelatin capsules (NDC 64011-142-19). Store at controlled room temperature 15°-30° C (59°-86° F).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Mktd. by Ther-Rx Corp.
St. Louis, MO 63044
U.S. Patent Nos.: 4,822,816; 5,070,085; 6,197,329; 6,258,846; 6,569,857; 6,576,666.
Other U.S. Patents Pending