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Chromagen

Generic Name: iron supplement
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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

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: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.

DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

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 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.

​Sugar Free            75854-320-30

Lactose Free         Rx Only Dietary Supplement

Chromagen​TM

www.Chromagenrx.com            30 softgels

Chromagen 
ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor capsule
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-320
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 25 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 50 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 750 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 250 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
ZINC (ZINC) ZINC 12 mg
INTRINSIC FACTOR (INTRINSIC FACTOR) INTRINSIC FACTOR 100 mg
Inactive Ingredients
Ingredient Name Strength
SOYBEAN OIL  
GELATIN TYPE B BOVINE (200 BLOOM)  
GLYCERIN  
WATER  
CAROB  
CARAMEL  
FD&C BLUE NO. 1  
YELLOW WAX  
LECITHIN, SOYBEAN  
Product Characteristics
Color blue (pearlescent dark blue) Score no score
Shape CAPSULE Size 22mm
Flavor Imprint Code CH75
Contains     
Packaging
# Item Code Package Description
1 NDC:75854-320-30 30 CAPSULE in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/23/2017
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 03/2017
 
Avion Pharmaceuticals, LLC



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