{"adverse_reactions":["ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid."],"boxed_warning":["WARNING: 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.","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."],"contraindications":["CONTRAINDICATIONS : Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients."],"description":["DESCRIPTION: Chromagen™ for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side. Chromagen Supplement Facts Panel"],"dosage_and_administration":["DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician."],"effective_time":"20260417","how_supplied":["HOW SUPPLIED: Bottles of 30 softgels (75854-320-30). 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."],"id":"4fa9661d-ca86-cfa2-e063-6394a90a5b2e","inactive_ingredient":["OTHER INGREDIENTS: Beeswax, soybean oil and soy lecithin. Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), caramel coloring, carob, glycerin, FD&C Blue #1, purified water)."],"indications_and_usage":["INDICATIONS: Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency."],"openfda":{"brand_name":["Chromagen"],"generic_name":["FERROUS ASPARTO GLYCINATE, FERROUS FUMARATE, ASCORBIC ACID, FOLIC ACID, LEVOMEFOLATE GLUCOSAMINE, CYANOCOBALAMIN, ZINC, AND INTRINSIC FACTOR"],"is_original_packager":[true],"manufacturer_name":["Avion Pharmaceuticals, LLC"],"nui":["N0000193618","M0001797","M0022794","N0000175951"],"package_ndc":["75854-320-30"],"pharm_class_cs":["Ascorbic Acid [CS]","Vitamin B 12 [CS]"],"pharm_class_epc":["Vitamin C [EPC]","Vitamin B12 [EPC]"],"product_ndc":["75854-320"],"product_type":["HUMAN PRESCRIPTION DRUG"],"route":["ORAL"],"spl_id":["4fa9661d-ca86-cfa2-e063-6394a90a5b2e"],"spl_set_id":["13c5ed58-6333-498f-9ace-1049d7ae3552"],"substance_name":["FERROUS ASPARTO GLYCINATE","FERROUS FUMARATE","ASCORBIC ACID","LEVOMEFOLATE GLUCOSAMINE","FOLIC ACID","CYANOCOBALAMIN","ZINC","INTRINSIC FACTOR"],"unii":["H7426RGB3L","R5L488RY0Q","PQ6CK8PD0R","Q65PL71Q1A","935E97BOY8","P6YC3EG204","J41CSQ7QDS","70BT6OQT2Q"]},"package_label_principal_display_panel":["75854-320-30 SUGAR FREE LACTOSE FREE Rx Only Dietary Supplement Chromagen™ 30 softgels Chromagen BL"],"precautions":["PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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."],"set_id":"13c5ed58-6333-498f-9ace-1049d7ae3552","spl_product_data_elements":["Chromagen ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, levomefolate glucosamine, cyanocobalamin, zinc, and intrinsic factor SOYBEAN OIL GELATIN TYPE B BOVINE (200 BLOOM) GLYCERIN WATER CAROB CARAMEL FD&C BLUE NO. 1 BEESWAX LECITHIN, SOYBEAN FERROUS ASPARTO GLYCINATE FERROUS CATION FERROUS FUMARATE FERROUS CATION ASCORBIC ACID ASCORBIC ACID LEVOMEFOLATE GLUCOSAMINE LEVOMEFOLIC ACID FOLIC ACID FOLIC ACID CYANOCOBALAMIN CYANOCOBALAMIN ZINC ZINC INTRINSIC FACTOR INTRINSIC FACTOR pearlescent dark blue CH75"],"spl_unclassified_section":["MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0203 Rev. 0525-03 Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent #7,947,662 CAS #1181972-37-1 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. THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE."],"storage_and_handling":["STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN."],"version":"10"}