DESCRIPTION: Chromagen™ for oral administration is a prenatal/postnatal iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side.
OTHER INGREDIENTS: Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), carob [St. John's Bread and Caramel], FD&C Blue #1, glycerin, purified water), soybean oil, soy lecithin and beeswax.
INDICATIONS:Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
CONTRAINDICATIONS: Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.
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.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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.
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.
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 30005 1-888-61-AVION
Rev. 0519-02 AV-426
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.
