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PrimaCare One Capsules (Ther-Rx)
DESCRIPTION
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:
Omega-3 Fatty Acids 300 mg Linoleic Acid 30 mg Linolenic Acid 30 mg Vitamins:
Folic Acid, USP 1 mg Vitamin B 6 (as pyridoxine HCl) 25 mg Vitamin C (as Ester-C ®) * 25 mg Vitamin D 3 (from cholecalciferol) 170 IU Vitamin E (from dl-alpha-tocopheryl acetate) 30 IU Minerals:
Calcium 150 mg Iron (as carbonyl iron) 27 mg * Ester-C ® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C ® is a licensed trademark of Zila Nutraceuticals, Inc.
Inactive Ingredients: Gelatin, vegetable shortening, glycerine, soybean oil, yellow beeswax, lecithin, titanium dioxide, methylparaben, ethylvanillin, D&C Red #33, propylparaben, FD&C Blue #1.
INDICATIONS
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.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
WARNING
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.
WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
PRECAUTIONS
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.
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 capsule daily, or as prescribed by a physician.
HOW SUPPLIED
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.
P4350 11/03
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
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