ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

BOXED WARNING SECTION.


WARNING. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.


DESCRIPTION. PNV-Omega is 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.. facts. 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. (tartrazine) and FD&C Yellow No. 6. INDICATIONS. PNV Omega is 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 known hypersensitivity to any of the ingredients.

DOSAGE & ADMINISTRATION SECTION.


DOSAGE AND ADMINISTRATION. Before, during and/or after pregnancy, one softgel daily or as directed by physician.

HOW SUPPLIED SECTION.


HOW SUPPLIED. PNV Omega is supplied in child-resistant bottles of 30 softgels (42192-332-30). The listed product is not 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.

INULLCTIVE INGREDIENT SECTION.


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. (tartrazine) and FD&C Yellow No. 6.

INDICATIONS & USAGE SECTION.


INDICATIONS. PNV Omega is multivitamin/ multimineral dietary supplement indicated for use in the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 30 Softgel Tablets. NDC 42192-332-30PNV OmegaRx Prenatal Vitamin and DHARx Only 30 SoftgelsAcella PHARMACEUTICALS, LLC. Omega.

PRECAUTIONS SECTION.


PRECAUTIONS. Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin 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.

SPL UNCLASSIFIED SECTION.


PNV OmegaRx Only.

WARNINGS SECTION.


WARNING. Ingestion of more than 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.