WARNING Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
BOXED WARNING SECTION.
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 30 Softgel Tablets NDC 42192-332-30 PNV - Omega Rx Prenatal Vitamin and DHA Rx Only 30 Softgels Acella PHARMACEUTICALS, LLC
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
SPL UNCLASSIFIED SECTION.
MANUFACTURED FOR: Acella Pharmaceuticals, LLC Alpharetta, GA 30005 1-800-541-4802 Rev 1218-04
HOW SUPPLIED SECTION.
HOW SUPPLIED PNV - Omega is supplied in child-resistant bottles of 30 softgels (42192-332-30). The listed product is not a National Drug Code, but has merely been formatted to comply with standard industry practice for pharmacy and insurance computer systems. Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F). [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
DESCRIPTION PNV-Omega is a prescription prenatal/postnatal dietary supplement softgel capsule that contains multivitamins and minerals along with essential fatty acids. Each softgel is green in color, opaque and imprinted with 332 on one side. OTHER INGREDIENTS Gelatin capsule (bovine gelatin, glycerin, purified water, titanium dioxide, FD&C Yellow #5, FD&C Blue #1, and FD&C Yellow #6), soy lecithin, vegetable shortening, and yellow beeswax. Contains soy. Contains FD&C Yellow No. 5 (tartrazine) and FD&C Yellow No. 6. INDICATIONS PNV - Omega is a multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
PRECAUTIONS 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 pernicious anemia in that hematologic remission can occur while neurological manifestations progress.