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.

CONTRAINDICATIONS SECTION.

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

DESCRIPTION SECTION.

DESCRIPTION: PRENATE MINI (R) is prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with Mini. Contains fish oil and soy. Contains FD&C Yellow No. (tartrazine) as color additive.. fact.

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 (75854-0315-30). 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: Bovine gelatin, FD&C Blue 1, FD&C Yellow 5, fish (tuna) oil, glycerin, purified water, soy lecithin, titanium dioxide, vegetable shortening and yellow beeswax.

INDICATIONS & USAGE SECTION.

INDICATIONS: PRENATE MINI (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. PRENATEMINI (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. 75854-0315-30Rx Only Dietary SupplementPrenate mini (R) small, easy-to-swallow softgel with complete prenatal nutrition support, including 350 mg of DHA 30 SoftgelsSUGAR FREEGLUTEN FREE LACTOSE FREE Avion PHARMACEUTICALS mini.

PRECAUTIONS SECTION.

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic 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. This product contains FD&C Yellow No. (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

SPL UNCLASSIFIED SECTION.

Rx Only Dietary Supplement.

STORAGE AND HANDLING SECTION.

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