NIFEREX- ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid tablet

Niferex by

Drug Labeling and Warnings

Niferex by is a Prescription medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Rx Only Dietary Supplement

DESCRIPTION

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

INACTIVE INGREDIENT

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.

INDICATIONS & USAGE

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

CONTRAINDICATIONS

CONTRAINDICATIONS: Niferex® 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

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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: One tablet daily, or as directed by a physician. 

HOW SUPPLIED

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.

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.]

SPL UNCLASSIFIED SECTION

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.

KEEP THIS AND ALL MEDICATION OUT OF THE REACH OF CHILDREN.

MANUFACTURED FOR:

Avion Pharmaceuticals, LLC

Alpharetta, GA 30005 1-888-61-AVION

L-0437  Rev. 0924-01

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.

PRINCIPAL DISPLAY PANEL

75854-344-30

​Rx Only Dietary Supplement

30 Tablets

Sugar Free

Lactose Free

Niferex​® Tablets (ferrous asparto glycinate)

www.niferex.com

INGREDIENTS AND APPEARANCE

NIFEREX 
ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, and succinic acid tablet

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 75854-344
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	75 mg
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	175 mg
LEVOMEFOLIC ACID (UNII: 8S95DH25XC) (LEVOMEFOLIC ACID - UNII:8S95DH25XC)	LEVOMEFOLIC ACID	750 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	250 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	25 mg
ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS)	ZINC	15 mg
SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L)	SUCCINIC ACID	150 mg
INTRINSIC FACTOR (UNII: 70BT6OQT2Q) (INTRINSIC FACTOR - UNII:70BT6OQT2Q)	INTRINSIC FACTOR	100 mg

Inactive Ingredients
Ingredient Name	Strength
CALCIUM PHOSPHATE, DIBASIC, DIHYDRATE (UNII: O7TSZ97GEP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
MAGNESIUM STEARATE (UNII: 70097M6I30)
STEARIC ACID (UNII: 4ELV7Z65AP)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
HYDROXYPROPYL METHYLCELLULOSE (UNII: 3NXW29V3WO)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
TRIACETIN (UNII: XHX3C3X673)

Product Characteristics
Color	brown (copper colored)	Score	no score
Shape	OVAL	Size	19mm
Flavor		Imprint Code	344
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 75854-344-30	30 in 1 BOTTLE; Type 0: Not a Combination Product	12/16/2024

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		12/16/2024

Labeler - Avion Pharmaceuticals, LLC (040348516)

Registrant - Avion Pharmaceuticals, LLC (965450542)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-344)