RE Iron Tablets

Generic Name: iron pentacarbonyl, folic acid, cyanocobalamin, ascorbic acid and docusate sodium
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.

RE Iron Tablets 90 mg

Indications and Usage for RE Iron Tablets

RE Iron Tablets 90mg is indicated for the prevention and treatment of iron deficiency anemia and/or nutritional megaloblastic anemias.

RE Iron Tablets Dosage and Administration

One tablet daily or as directed by a physician.

Contraindications

RE Iron Tablets 90mg is contraindicated in patients with known hypersensitivity to any of its ingredients. Folic acid (pteroylglutamic acid) is contraindicated in patients with untreated and uncomplicated pernicious anemia and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron stage disease dude to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.) pyridoxine responsive anemia or cirrhosis of the liver.

Warnings and Precautions

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

General: Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with RE Iron Tablets 90mg. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Folic Acid: Folic acid in doses above 1.0 mg daily may obscure pernicious anemia.

Adverse Reactions

Allergic sensitivity reactions and gastrointestinal disturbances may occur with iron therapy. Folic Acid allergic sensitization has been reported following both oral and parenteral administration.

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

Drug Interactions

There is a variety of iron/drug interactions which include antacids, tetracyclines, or fluoroquinolones.

USE IN SPECIFIC POPULATIONS

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects,. In general, dose selection for an elderly patient should be made cautiously, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.

Overdosage

The clinical course of acute iron overdosage can vary. Initial symptoms may include abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock and coma.

RE Iron Tablets Description

Each reddish-brown, film-coated tablet for oral administration contains:
Iron (Carbonyl Iron) 90 mg
Folic Acid 1 mg
Vitamin B12 (Cyanocobalamin) 12 mcg
Vitamin C (Ascorbic acid) 120 mg
Docusate sodium 50 mg

Inactive ingredients: Sodium Benzoate, Silicon Dioxide, Microcrystalline Cellulose, Stearic Acid, Croscarmellose Sodium, Dicalcium Phosphate Dihydrate, Talc, FD&C Yellow No.6, FD&C Red No.40, FD&C Blue No.2, and Macrogol.

RE Iron Tablets - Clinical Pharmacology

Iron is necessary for the proper functioning of hemoglobin and red blood cell production.
Folic acid is required for cell division and growth and the maintenance of red blood cells.
Vitamin B12 is required for the maintenance of normal red blood cell synthesis, cell reproduction and normal growth. Intrinsic factor, a gastric protein secreted by the parietal cells, is required for the absorption of Vitamin B12 from the gastrointestinal tract.

Warning

Pernicious anemia should be ruled out before starting treatment. While folic acid corrects the hematological profile or pernicious anemia, it does not ameliorate the underlying neurologic involvement.

How Supplied/Storage and Handling

RE Iron Tablets 90 mg (NDC 68032-371-90) is a reddish-brown, modified rectangle shaped, film-coated tablet, debossed with “RE 371” on one side and blank on the other, and packaged in bottles of 90.

Store at 25C (77F). Excursions permitted to 15-30C (59-86F). (See USP Controlled Room Temperature.)
NOTICE: Contact with moisture can discolor or erode the tablet. Do not chew tablet.

PACKAGING

IRON 
iron pentacarbonyl tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:68032-371
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
IRON PENTACARBONYL (IRON) IRON PENTACARBONYL 90 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
DOCUSATE SODIUM (SODIUM CATION) DOCUSATE SODIUM 50 mg
Inactive Ingredients
Ingredient Name Strength
SODIUM BENZOATE  
SILICON DIOXIDE  
CELLULOSE, MICROCRYSTALLINE  
STEARIC ACID  
CROSCARMELLOSE SODIUM  
DIBASIC CALCIUM PHOSPHATE DIHYDRATE  
TALC  
FD&C YELLOW NO. 6  
FD&C RED NO. 40  
FD&C BLUE NO. 2  
POLYETHYLENE GLYCOL  
Product Characteristics
Color brown Score no score
Shape RECTANGLE Size 10mm
Flavor Imprint Code RE;371
Contains         
Packaging
# Item Code Package Description
1 NDC:68032-371-90 90 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 04/01/2009 06/30/2011
Labeler - River's Edge Pharmaceuticals, LLC (133879135)
Revised: 12/2010
 
River's Edge Pharmaceuticals, LLC
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