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

DESCRIPTION SECTION.

DESCRIPTION: PRENATE (R) Restore is prescription postnatal vitamin dietary supplement that contains probiotics, DHA and advanced calcium. Each dark blue softgel is imprinted with Omega Rx on one side and blank on the other. fact.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by physician.

HOW SUPPLIED SECTION.

HOW SUPPLIED: Bottles of 30 softgels (75854-308-30). 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 insurancecomputer systems.

INACTIVE INGREDIENT SECTION.

OTHER INGREDIENTS: Gelatin capsule (gelatin, sorbitol, glycerin, purified water, FD&C Blue 1, titanium dioxide, and FD&C Red 3), beeswax, soy lecithin, and palm shortening.

INDICATIONS & USAGE SECTION.

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

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

PRINCIPAL DISPLAY PANEL 30 Softgel label. 75854-308-30 PRENATE (R) RestoreRx postnatal vitamin with probiotics, DHAand chelated ironRx Only Dietary Supplement 30 Softgels Avion PHARMACEUTICALS restore.

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.

SPL UNCLASSIFIED SECTION.

Rx postnatal vitamin with probiotics, DHA and chelated iron 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.].

WARNINGS SECTION.

KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.