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: PRENATE PIXIE(R) is contraindicated in patients with known hypersensitivity to any of the ingredients.
Rx OnlyDESCRIPTION: PRENATE PIXIE(R) is prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with PIX. Supplement Facts. OTHER INGREDIENTS: Capsule gelatin (gelatin, glycerin, purified water, titanium dioxide, FD&C red 40, caramel, and FD&C blue 1), palm shortening, soy lecithin, and yellow beeswax. PRENATE PIXIE(R) contains fish oil and soy.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one softgel daily or as directedby physician.
HOW SUPPLIED SECTION.
HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). 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, glycerin, purified water, titanium dioxide, FD&C red 40, caramel, and FD&C blue 1), palm shortening, soy lecithin, and yellow beeswax. PRENATE PIXIE(R) contains fish oil and soy.
INDICATIONS & USAGE SECTION.
INDICATIONS: PRENATE PIXIE(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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
75854-0316-30Prenate pixie(R)Robust Rx Prenatal Vitamin with 11 concentrated nutrients and minerals in tiny softgel packageSUGAR FREEGLUTEN FREELACTOSE FREERx OnlyDietary Supplement30 Softgels. prenate pixie.
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.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.Sumalate(R) is registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 5,516,925, 6,716,814, 8,007,846, and 8,425,956.MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, Georgia 30005 1-888-61-AVION Rev. 0519-03.
STORAGE AND HANDLING SECTION.
STORAGE: Store at 20 25C (68 77F); excursions permitted to 15 30C (59 86F)[See USP Controlled Room Temperature.].