HOW SUPPLIED SECTION.


HOW SUPPLIED: Bottles of 30 softgels (75854-313-30). The listed product number is not National Drug Code. Instead, Avion Pharmaceuticals has assigned product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.

INACTIVE INGREDIENT SECTION.


OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, yellow beeswax and soybean oil.

INDICATIONS & USAGE SECTION.


INDICATIONS: PRENATE ESSENTIAL (R) 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. PRENATE ESSENTIAL (R) can also be beneficial in improving the nutritional status of women prior to conception.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PACKAGE LABEL.PRINCIPAL DISPLAY PANEL. 75854-313-30PRENATE ESSENTIAL (R) Rx prenatal vitamin DHA Key vitamins, minerals, and DHA support nutritionGLUTEN FREE Rx Only Dietary Supplement 30 Softgels. Essencial.

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.


Rx prenatal vitamin DHA Rx Only.

STORAGE AND HANDLING SECTION.


STORAGE: Store at 20 25C (68 77F); excursions permitted to 15 30C (59 86F) [See USP Controlled Room Temperature.].

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 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: PRENATE ESSENTIAL (R) is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.


DESCRIPTION: PRENATE ESSENTIAL (R) is prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is green in color, opaque, and imprinted with Prenate on one side and blank on the other. PRENATE ESSENTIAL (R) contains fish oil and soy. Prenate Essencial. OTHER INGREDIENTS: Capsule gelatin (gelatin, sorbitol, glycerin, purified water, turmeric, and sodium copper chlorophyllin), soy lecithin, yellow beeswax and soybean oil.

DOSAGE & ADMINISTRATION SECTION.


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