FDA Label for Chromagen
View Indications, Usage & Precautions
Chromagen Product Label
The following document was submitted to the FDA by the labeler of this product Avion Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Description
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 | ||
Inactive Ingredient
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.
Indications & Usage
INDICATIONS:Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
Contraindications
CONTRAINDICATIONS: Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Precautions
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.
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.
Adverse Reactions
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
Dosage & Administration
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.
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.
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.
Other
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 NOT INTENDED TO DIAGNOSE, TREAT, CURE OR INTENDED TO DIAGNOSE, PREVENT ANY DISEASE.
Package Label.Principal Display Panel
Sugar Free 75854-320-30
Lactose Free Rx Only Dietary Supplement
ChromagenTM
www.chromagenrx.com 30 softgels
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