CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS: PNV-DHA is contraindicated in patients with known hypersensitivity to any of the ingredients.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 30 Softgel Tablets. NDC 42192-321-30PNV-DHARx Prenatal Vitamin and DHARx Only 30 SoftgelsAcella PHARMACEUTICALS, LLC Bottle Label.

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.

DESCRIPTION SECTION.

DESCRIPTION: PNV-DHA is prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is cobalt blue in color, opaque and imprinted with BP 321 on one side and blank on the other. PNV-DHA can also be beneficial in improving the nutritional status of women prior to conception. Supplement Facts Panel. PNV-DHA contains fish oil and soy.OTHER INGREDIENTS: Beeswax, soy lecithin and vegetable shortening. Coating contains: Bovine gelatin, FD&C Blue No. 1, FD&C Red No. 3, glycerin, purified water and titanium dioxide. Contains Soy. INDICATIONS: PNV-DHA is multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. CONTRAINDICATIONS: PNV-DHA 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: Bottles of 30 softgels (42192-321-30). The listed product number is not National Code. Instead, Acella Pharmaceuticals has assigned product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems. STORAGE: Store at 20 25C (68 77F); excursions permitted to 15 30C (59 86F) [See USP Controlled Room Temperature.].

INACTIVE INGREDIENT SECTION.

PNV-DHA contains fish oil and soy.OTHER INGREDIENTS: Beeswax, soy lecithin and vegetable shortening. Coating contains: Bovine gelatin, FD&C Blue No. 1, FD&C Red No. 3, glycerin, purified water and titanium dioxide. Contains Soy.

INDICATIONS & USAGE SECTION.

INDICATIONS: PNV-DHA is multivitamin/multimineral fatty acid dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.

ADVERSE REACTIONS SECTION.

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

BOXED WARNING 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.