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Generic Name: iron supplement
Dosage Form: tablet

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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.

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

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.

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

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.

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. 1016-05 AV-428

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.

​Rx Only Dietary Supplement       75854-321-30

30 Tablets                                      Sugar Free

Lactose Free

Niferex​TM

www.Niferexrx.com            tablets

Niferex 
ferrous asparto glycinate, iron, ascorbic acid, folic acid, cyanocobalamin, zinc, succinic acid, and intrinsic factor tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-321
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 50 mg
IRON DEXTRAN (FERRIC CATION) FERRIC CATION 100 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 60 mg
LEVOMEFOLIC ACID (LEVOMEFOLIC ACID) LEVOMEFOLIC ACID 750 ug
FOLIC ACID (FOLIC ACID) FOLIC ACID 250 ug
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 25 ug
ZINC (ZINC) ZINC 15 mg
SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 50 mg
INTRINSIC FACTOR (INTRINSIC FACTOR) INTRINSIC FACTOR 100 mg
Inactive Ingredients
Ingredient Name Strength
CALCIUM PHOSPHATE, DIBASIC, ANHYDROUS  
CELLULOSE, MICROCRYSTALLINE  
CROSCARMELLOSE SODIUM  
MAGNESIUM STEARATE  
SILICON DIOXIDE  
Product Characteristics
Color brown (copper colored) Score no score
Shape ROUND Size 19mm
Flavor Imprint Code NxFE
Contains     
Packaging
# Item Code Package Description
1 NDC:75854-321-30 30 TABLET in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 01/23/2017
Labeler - Avion Pharmaceuticals, LLC (965450542)
Registrant - Avion Pharmaceuticals, LLC (965450542)
Establishment
Name Address ID/FEI Operations
Avion Pharmaceuticals, LLC 965450542 manufacture(75854-321)
Revised: 03/2017
 
Avion Pharmaceuticals, LLC
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