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 - 30 softgel container image 75854-0316-30 Prenate pixie Robust Rx Prenatal Vitamin with 11 concentrated nutrients and minerals in a tiny softgel package GLUTEN FREE R x Only Prenatal Supplement 30 Softgels Avion PHARMACUETICALS
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
INDICATIONS: PRENATE PIXIE 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.
HOW SUPPLIED SECTION.
HOW SUPPLIED: Bottles of 30 softgels (75854-0316-30). 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.
SPL UNCLASSIFIED SECTION.
Sumalate is a 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. PRENATE Pixie 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. 1014
DESCRIPTION: PRENATE PIXIE is a prescription prenatal/postnatal multivitamin/mineral/essential fatty acid softgel. Each softgel is purple in color, opaque, and imprinted with PIX. Supplement Facts Serving Size: 1 Softgel Amount per Serving: % Daily Value % Daily Value (Pregnant & Lactating Women) Vitamin C (as ascorbic acid) 30 mg 50% 50% Biotin 75 mcg 25% 25% Vitamin D3 (as cholecalciferol) 500 IU 125% 125% Vitamin B12 (as cyanocobalamin) 13 mcg 217% 163% Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg of folic acid) and folic acid, USP 400 mcg) 1 mg 250% 125% Iron (as ferrous asparto glycinate) Sumalate 10 mg 56% 56% Iodine (as potassium iodide) 150 mcg 100% 100% Vitamin B6 (as pyridoxine HCl) 5 mg 250% 200% Vitamin E (as dl-alpha tocopheryl acetate) 10 IU 33% 33% Docosahexaenoic acid (DHA) 200 mg Blueberry extract (vaccinium spp.) 5 mg Daily Value (DV) not established. PRENATE PIXIE contains fish oil and soy.
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: Store at 20 - 25C (68 - 77F); excursions permitted to 15 - 30C (59 - 86F) [See USP Controlled Room Temperature.]
INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS: Bovine gelatin, glycerin, yellow beeswax, soy lecithin, vegetable shortening, purified water, titanium dioxide, FD&C Red #40, caramel and FD&C Blue #1.
CONTRAINDICATIONS: PRENATE PIXIE is contraindicated in patients with a known hypersensitivity to any of the ingredients.