PRECAUTIONS SECTION.


PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and othermegaloblastic 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 progress.

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.

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 childrenunder 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 theingredients.

DESCRIPTION SECTION.


DESCRIPTION: PNV-DHA is prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel.Each softgel is blue in color, opaque and imprinted with BP 321 on one side. Supplement FactsServing Size TabletAmount Per Serving DV %DV for Pregnant or Lactating Women Vitamin C85 mg142%142%Vitamin 3 200 IU50%50%Vitamin E10 IU33%33%Vitamin 6 25 mg1250%1000%Folate1 mg250%125%(L-methylfolate calcium 676 mcg (as Xolafin-B(TM) Percent Daily Values are based on 2000 calorie diet) molar equivalent to 600 mcg of Folic Acid) (folic acid, USP 400 mcg)Vitamin 12 12 mcg200%150%Calcium140 mg14%11%Iron (ferrous fumarate)27 mg150%150%Magnesium45 mg11%10%Docosahexaenoic Acid (DHA) (from omega-3 fatty acids) 300 mgDaily Value (DV) not established. OTHER INGREDIENTS: bees wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue 1, FD&C Red 3. INDICATIONS: PNV-DHA is multivitamin/multimineral nutritional supplement indicated for use in the dietarymanagement 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 theingredients.

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-DHA is supplied in child-resistant bottles of 30 softgels (NDC 42192-321-30). Store at 20 25C (68 77F); excursions permitted to 15 30C (59 86F) [See USP Controlled Room Temperature.].

INACTIVE INGREDIENT SECTION.


OTHER INGREDIENTS: bees wax, hydrogenated vegetable oil, lecithin, gelatin, glycerin, purified water, titanium dioxide, FD&C Blue 1, FD&C Red 3.

INDICATIONS & USAGE SECTION.


INDICATIONS: PNV-DHA is multivitamin/multimineral nutritional supplement indicated for use in the dietarymanagement of patients with nutritional deficiencies or are in need of nutritional supplementation.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


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