Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

PrimaCare® ONE (prescription prenatal, postnatal multivitamin) A once-daily prenatal vitamin supplement, including key omega-3 fatty acids (DHA and EPA) and 1 mg folic acid DESCRIPTION PrimaCare®ONE is a prescription prenatal/ postnatal multivitamin/mineral capsule with omega-3 fatty acids. Each purple soft gelatin capsule for oral administration contains: Essential Fatty Acids: Omega-3 Fatty Acids....................330 mg Docosahexaenoic Acid (DHA) ............260 mg Eicosapentaenoic Acid (EPA) ..............40 mg a-Linolenic Acid (ALA)...................30 mg Linoleic Acid...........................30 mg Vitamins: Vitamin C (as Ester-C®*) ..................25 mg Vitamin D3 (cholecalciferol)................170IU Vitamin E (dl-alpha-tocopheryl acetate).........30IU Folic Acid, USP..........................1 mg Vitamin B6 (pyridoxine hydrochloride).........25 mg Minerals: Calcium.............................150 mg Iron Carbonyl iron (elemental iron) .............20 mg Sumalate™† (elemental iron) ...............7 mg *Ester-C® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C® is a licensed trademark of The Ester C Company. †Sumalate™ (ferrous asparto glycinate) is a trademark of Albion International, Inc., Clearfield, Utah. U.S. Patent pending. Inactive Ingredients: D&C Red No. 33, ethylvanillin, FD&C Blue No. 1, gelatin, glycerine, hydrogenated vegetable oil, lecithin, malic acid, methylparaben, propylparaben, silicon dioxide, soybean oil, succinic acid, titanium dioxide, vegetable shortening, and yellow beeswax.

INDICATIONS PrimaCare® ONE (prescription prenatal, postnatal multivitamin) is indicated to provide vitamin/mineral and omega-3 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. DOSAGE AND ADMINISTRATION Usual dosage is one capsule daily, or as prescribed by a physician. HOW SUPPLIED PrimaCare® ONE (prescription prenatal, postnatal multivitamin) prenatal/postnatal multivitamin/mineral capsules are purple soft gelatin capsules, imprinted "Ther-Rx 200" in white ink, packaged in bottles of 30 capsules (NDC 64011-200-19). Store at controlled room temperature 15°-30° C (59°-86° F). KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN. 03/07. Manufactured by Accucaps Industries Limited Windsor, Ontario, Canada. Marketed by Ther-Rx Corporation St. Louis, MO 63044. FDA rev date: n/a

PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.

OVERDOSE No information provided. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

SIDE EFFECTS Allergic sensitization has been reported following both oral and parenteral administration of folic acid. DRUG INTERACTIONS No information provided.

WARNINGS Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. 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 Pediatric Use: Safety and effectiveness in pediatric patients have 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 an elderly patient 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.