Niferex Tablets

What is Niferex Tablets and how is it used?

Niferex Tablets is an over the counter medicine used to treat the symptoms of Iron Deficiency Anemia. Niferex Tablets may be used alone or with other medications.

Niferex Tablets belongs to a class of drugs called Iron Products.

What are the possible side effects of Niferex Tablets?

Niferex Tablets may cause serious side effects including:

• hives,
• difficulty breathing,
• swelling of your face, lips, tongue, or throat,
• rash,
• itching,
• red, swollen, blistered, or peeling skin with or without fever,
• wheezing,
• tightness in the chest or throat,
• trouble swallowing or talking,
• unusual hoarseness,
• black, tarry, or bloody stools,
• fever,
• very upset stomach,
• vomiting,
• vomit that looks like coffee grounds, and
• stomach cramps

Get medical help right away, if you have any of the symptoms listed above.

The most common side effects of Niferex Tablets include:

• constipation,
• diarrhea,
• nausea,
• upset stomach,
• black or dark colored stools, and
• temporary staining of the teeth

Tell the doctor if you have any side effect that bothers you or that does not go away.

These are not all the possible side effects of Niferex Tablets. For more information, ask your doctor or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

DESCRIPTION

Niferex for oral administrationis a prenatal/postnatal iron supplement that is a round, copper colored tablet with NxFE embossed on one side.

Supplement Facts Serving Size: 1 tablet
Amount per Serving:		% Daily Value
Iron (as Sumalate® (ferrous asparto glycinate 50 mg) 150 mg and polysaccharide iron complex 100 mg)	150 mg	833%
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)	25 mcg	417%
Zinc (as zinc-bisglycinate chelate	15 mg	100%
Succinic Acid	50 mg	†
Desiccated Stomach Substance	100 mg	†
†Daily Value (DV) not established

Other Ingredients

Dicalcium phosphate, microcrystalline cellulose, croscarmelose sodium, vegetable stearate, silicon dioxide.

INDICATIONS

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

DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one tablet daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 tablets (75854-321-30). 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.

Manufactured for: Avion Pharmaceuticals, LLC, Alpharetta, GA 30022. Revised: Mar 2017

SIDE EFFECTS

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

DRUG INTERACTIONS

No information provided.

WARNINGS

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.

OVERDOSE

No information provided.

CONTRAINDICATIONS

Niferex™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

CLINICAL PHARMACOLOGY

No information provided.

PATIENT INFORMATION

No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.