CHROMAGEN- ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor capsule 
Avion Pharmaceuticals, LLC

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.

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Iron Supplement

Chromagen TM

Rx Only Dietary Supplement

Rx Only Dietary Supplement

DESCRIPTION: Chromagen™ for oral administration is a prenatal/postnatal iron supplement softgel that is pearlescent dark blue and embossed with “CH75” on one side.

Ch

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.

DOSAGE AND ADMINISTRATION: One softgel 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 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.

75854-320-30

SUGAR FREE

LACTOSE FREE

Rx Only

Dietary Supplement

Chromagen™

30 softgels

chromagen label

CHROMAGEN 
ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, zinc, and intrinsic factor capsule
Product Information
Product TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC:75854-320
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION25 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION50 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID60 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC) LEVOMEFOLIC ACID750 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID250 ug
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN10 ug
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC12 mg
INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q) INTRINSIC FACTOR100 mg
Inactive Ingredients
Ingredient NameStrength
SOYBEAN OIL (UNII: 241ATL177A)  
GELATIN TYPE B BOVINE (200 BLOOM) (UNII: A7JR5F8DLH)  
GLYCERIN (UNII: PDC6A3C0OX)  
WATER (UNII: 059QF0KO0R)  
CAROB (UNII: 5MG5Z946UO)  
CARAMEL (UNII: T9D99G2B1R)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
Product Characteristics
Colorblue (pearlescent dark blue) Scoreno score
ShapeCAPSULESize22mm
FlavorImprint Code CH75
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC:75854-320-3030 in 1 BOTTLE; Type 0: Not a Combination Product01/23/2017
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
unapproved drug other01/10/2017
Labeler - Avion Pharmaceuticals, LLC (040348516)
Establishment
NameAddressID/FEIBusiness Operations
Avion Pharmaceuticals, LLC040348516manufacture(75854-320)

Revised: 7/2019
Document Id: 8d40d410-6610-3955-e053-2a95a90a753f
Set id: 13c5ed58-6333-498f-9ace-1049d7ae3552
Version: 4
Effective Time: 20190709
 
Avion Pharmaceuticals, LLC