Chromagen Capsule
FDA Label NDC 75854-320

Full FDA labeling including Indications, Dosage, Usage, and Precautions

Structured Product Label

The following Structured Product Label (SPL) was submitted to the FDA by Avion Pharmaceuticals, Llc for the product Chromagen (NDC 75854-320). This document serves as the official prescribing information, containing essential scientific data and clinical materials required for healthcare providers and patients.

This specific version of the label includes detailed information regarding description, inactive ingredient, indications & usage, contraindications, precautions, boxed warning, adverse reactions, dosage & administration, and other regulatory disclosures. Use the navigation below to review specific sections of the FDA submission.

Label Section Quick Index

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

Chromagen​TM

www.chromagenrx.com            30 softgels

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