Chromagen (ferrous asparto glycinate 25 mg ferrous fumarate 50 mg ascorbic acid 60 mg levomefolic acid 750 ug folic acid 250 ug cyanocobalamin 10 ug zinc 12 mg intrinsic factor 100 mg) Dailymed
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Boxed Warning Section
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Rx Only Dietary Supplement
Description Section
DESCRIPTION: Chromagen™ for oral administration is a prenatal/postnatal iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side.
Inactive Ingredient Section
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 & Usage Section
INDICATIONS:Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
Contraindications Section
CONTRAINDICATIONS: Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions Section
PRECAUTIONS:Â 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.
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.
Adverse Reactions Section
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration Section
DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.
How Supplied Section
HOW SUPPLIED:Â Bottles of 30 softgels (75854-320-30). The uled 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 And Handling Section
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.
Recent Major Changes Section
Package Label.principal Display Panel
75854-320-30
SUGAR FREE
LACTOSE FREE
Rx Only
Dietary Supplement
Chromagen™
30 softgels
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