INACTIVE INGREDIENT SECTION.
OTHER INGREDIENTS:Soybean oil, gelatin capsule (bovine gelatin, glycerin, purified water, carob, caramel coloring, FD&C Blue #1, Candurin Blue Shimmer (mica-based pearlescent pigment)), yellow beeswax and soy lecithin.
CONTRAINDICATIONS:Chromagen is contraindicated in patients with a known hypersensitivity to any of the ingredients.
BOXED WARNING SECTION.
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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
Sugar Free 75854-320-30 Lactose Free Rx OnlyDietary Supplement ChromagenTM www.chromagenrx.com 30 softgels
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
INDICATIONS & USAGE SECTION.
INDICATIONS: Chromagen is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
DOSAGE & ADMINISTRATION SECTION.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
HOW SUPPLIED SECTION.
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.
SPL UNCLASSIFIED SECTION.
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. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30022 1-888-61-AVION Rev. 1016-07 AV-426 THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOTINTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE.
DESCRIPTION: Chromagen for oral administration is a prenatal/postnatal iron supplement softgel that is pearlescent dark blue and embossed with CH75 on one side. Supplement Facts Serving Size: 1 softgel Amount per Serving: % Daily Value Iron (as Sumalate (ferrous asparto glycinate 25 mg) and ferrous fumarate 50 mg) 75 mg 417% Vitamin C (as ascorbic acid) 60 mg 100% Folate (as 1.4 mg Quatrefolic ((6S)-5, methyltetrahydrofolate glucosamine salt molar equivalent to 750 mcg of folic acid) and folic acid, USP 250 mcg) 1 mg 250% Vitamin B12 (as cyanocobalamin) 10 mcg 167% Zinc (as zinc bisglycinate chelate 12 mg 80% Desiccated Stomach Substance 100 mg Daily Value (DV) not established
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.] KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.