Iron Supplement

Drug Facts

Composition & Product

Active Ingredients

Ferrous Cation (75 mg) Ascorbic Acid (175 mg) Levomefolate Glucosamine (750 ug) Folic Acid (250 ug) Cyanocobalamin (25 ug) Zinc (15 mg) Succinic Acid (150 mg)

Inactive Ingredients

Calcium Phosphate, Dibasic, Dihydrate Cellulose, Microcrystalline Croscarmellose Sodium Magnesium Stearate Stearic Acid Silicon Dioxide Fd&c Blue No. 1 Fd&c Red No. 40 Fd&c Yellow No. 6 Hydroxypropyl Methylcellulose Titanium Dioxide Triacetin

Identifiers & Packaging

Pill Appearance

Imprint: 344 Shape: oval Color: brown Size: 19 mm Score: 1

Marketing Status

UNAPPROVED DRUG OTHER Active Since 2024-12-16

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: Niferex® 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 tablet daily, or as directed by a physician.

Dosage Forms and Strengths

HOW SUPPLIED: Bottles of 30 tablets (75854-344-30). 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: Niferex® is contraindicated in patients with a known hypersensitivity to any of the ingredients.

Description

DESCRIPTION: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with "344" embossed 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

Rx Only Dietary Supplement

Section 42232-9

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.

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.]

Section 51727-6

OTHER INGREDIENTS: Discalcium phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate. Coating contains: Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6), HPMC, titanium dioxide and triacetin.

This product contains FD&C Yellow #6.

Section 51945-4

75854-344-30

Rx Only Dietary Supplement

30 Tablets

Sugar Free

Lactose Free

Niferex^® Tablets (ferrous asparto glycinate)

www.niferex.com

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: Niferex® 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 tablet daily, or as directed by a physician.

Dosage Forms and Strengths (34069-5)

HOW SUPPLIED: Bottles of 30 tablets (75854-344-30). 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: Niferex® 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: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with "344" embossed on one side.

Section 42229-5 (42229-5)

Rx Only Dietary Supplement

Section 42232-9 (42232-9)

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.

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.]

Section 51727-6 (51727-6)

OTHER INGREDIENTS: Discalcium phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate. Coating contains: Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6), HPMC, titanium dioxide and triacetin.

This product contains FD&C Yellow #6.

Section 51945-4 (51945-4)

75854-344-30

Rx Only Dietary Supplement

30 Tablets

Sugar Free

Lactose Free

Niferex^® Tablets (ferrous asparto glycinate)

www.niferex.com

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: Niferex® 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 tablet daily, or as directed by a physician. ", "34069-5": "HOW SUPPLIED: Bottles of 30 tablets (75854-344-30). 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 : Niferex® 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: Niferex® for oral administration is an iron supplement that is an oval, copper colored, coated tablet with "344" embossed on one side.", "42229-5": "Rx Only Dietary Supplement", "42232-9": "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.", "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.]", "51727-6": "OTHER INGREDIENTS: Discalcium phosphate dihydrate, microcrystalline cellulose, croscarmellose sodium, stearic acid, silicon dioxide, magnesium stearate. Coating contains: Candurin® Orange (FD&C Blue #1, FD&C Red #40, FD&C Yellow #6), HPMC, titanium dioxide and triacetin. This product contains FD&C Yellow #6.", "51945-4": "75854-344-30 Rx Only Dietary Supplement 30 Tablets Sugar Free Lactose Free Niferex ® Tablets (ferrous asparto glycinate) www.niferex.com"}

Drug Facts

Composition & Product

Identifiers & Packaging

Medication Information

Structured Label Content

Advanced Ingredient Data

Raw Label Data

Additional Information