INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS: Fish (tuna) oil, bovine gelatin, glycerin, soy lecithin, yellow beeswax, purified water, vegetable shortening, FD&C Blue #1, titanium dioxide and FD&C Yellow #5.
CONTRAINDICATIONS: PRENATE MINI is contraindicated in patients with a known hypersensitivity to any of the ingredients.
BOXED WARNING SECTION.
WARNING: Ingestion of more than 3 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. Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or poison control center immediately.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL 75854-0315-30 Prenate mini A small, easy-to-swallow softgel with complete prenatal nutrition support, including 350 mg of DHA 30 Softgels Rx Only Prenatal Supplement GLUTEN FREE LACTOSE FREE Avion PHARMACEUTICALS
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
INDICATIONS: PRENATE MINI is a 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.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directed by a physician.
SPL UNCLASSIFIED SECTION.
Sumalate is a registered trademark of Albion Laboratories,Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814; 8,007,846; and 8,425,956. Ferronyl is a registered trademark of ISP Investments, Inc. PRENATE is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, Georgia 30022 1-888-61-AVION Rev. 1114
HOW SUPPLIED SECTION.
HOW SUPPLIED: Bottles of 30 softgels (75854-0315-30). The listed product number is not a National Drug Code. Instead, Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and healthcare insurance computer systems.
DESCRIPTION: PRENATE MINI is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each oval softgel is teal green in color and imprinted with Mini.
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.
STORAGE AND HANDLING SECTION.
STORAGE AND HANDLING SECTION: Store at 20 - 25C (68 - 77F); excursions permitted to 15 - 30C (59 - 86F) [See USP Controlled Room Temperature.]