Iron Supplement

Drug Facts

Composition & Product

Active Ingredients

Ferrous Cation (25 mg) Ascorbic Acid (50 mg) Levomefolic Acid (60 mg) Folic Acid (750 ug) Cyanocobalamin (250 ug) Zinc (10 ug) Intrinsic Factor (12 mg)

Inactive Ingredients

Soybean Oil Gelatin Type B Bovine (200 Bloom) Glycerin Water Carob Caramel Fd&c Blue No. 1 Yellow Wax Lecithin, Soybean

Identifiers & Packaging

Pill Appearance

Imprint: CH75 Shape: capsule Color: blue Size: 22 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2017-01-10

Medication Information

Recent Major Changes

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.

Indications and Usage

INDICATIONS: Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

Dosage and Administration

DOSAGE AND ADMINISTRATION:One softgel daily, or as directed by a physician.

Dosage Forms and Strengths

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.

Contraindications

CONTRAINDICATIONS: Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with CH75 on one side.

Section 34084-4

ADVERSE REACTIONS:Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Section 42229-5

Section 42232-9

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B ₁₂is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Section 44425-7

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.

Section 51727-6

OTHER INGREDIENTS: Beeswax, soybean oil and soy lecithin. Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), caramel coloring, carob, glycerin, FD&C Blue #1, purified water).

Section 51945-4

75854-320-30

SUGAR FREE

LACTOSE FREE

Rx Only

Dietary Supplement

Chromagen™

30 softgels

Structured Label Content

Recent Major Changes (34066-1)

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.

Indications and Usage (34067-9)

INDICATIONS: Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

Dosage and Administration (34068-7)

DOSAGE AND ADMINISTRATION:One softgel daily, or as directed by a physician.

Dosage Forms and Strengths (34069-5)

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.

Contraindications (34070-3)

CONTRAINDICATIONS: Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Section 34084-4 (34084-4)

ADVERSE REACTIONS:Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Description (34089-3)

DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with CH75 on one side.

Section 42229-5 (42229-5)

Section 42232-9 (42232-9)

PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B ₁₂is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.

Section 44425-7 (44425-7)

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.

Section 51727-6 (51727-6)

OTHER INGREDIENTS: Beeswax, soybean oil and soy lecithin. Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), caramel coloring, carob, glycerin, FD&C Blue #1, purified water).

Section 51945-4 (51945-4)

75854-320-30

SUGAR FREE

LACTOSE FREE

Rx Only

Dietary Supplement

Chromagen™

30 softgels

Advanced Ingredient Data

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Raw Label Data

All Sections (JSON)

{"34066-1": "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.", "34067-9": "INDICATIONS: Chromagen™ is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.", "34068-7": "DOSAGE AND ADMINISTRATION: One softgel daily, or as directed by a physician.", "34069-5": "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.", "34070-3": "CONTRAINDICATIONS : Chromagen™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.", "34084-4": "ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.", "34089-3": "DESCRIPTION: Chromagen for oral administration is an iron supplement softgel that is pearlescent dark blue and embossed with CH75 on one side.", "42229-5": "THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. MANUFACTURED FOR: Avion Pharmaceuticals, LLC Alpharetta, GA 30005 1-888-61-AVION L-0203 Rev. 0325-02 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.", "42232-9": "PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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.", "44425-7": "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.", "51727-6": "OTHER INGREDIENTS: Beeswax, soybean oil and soy lecithin. Gelatin capsule (bovine gelatin, Candurin® Blue Shimmer (mica-based pearlescent pigment), caramel coloring, carob, glycerin, FD&C Blue #1, purified water).", "51945-4": "75854-320-30 SUGAR FREE LACTOSE FREE Rx Only Dietary Supplement Chromagen™ 30 softgels"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information