Skip to Content

Niron Komplete

Generic Name: ascorbic acid, .alpha.-tocopherol, folic acid, cyanocobalamin and iron
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.

Niron Komplete

Supplement Facts
Serving Size: 1 Tablet


Amount Per Serving
Vitamin C
120 mg
Vitamin E
20 IU
Folic acid
1 mg
Vitamin B12
12 mcg
Iron (as ferrous fumarate and ferrous II bis-glycinate chelate)
30 mg
OTHER INGREDIENTS: microcrystalline cellulose, starch, silica, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C red no. 40, FD&C blue no. 1 & no. 2

INDICATIONS AND USAGE:

Niron Komplete is a prescription iron supplement indicated for use in improving the nutritional status of iron deficiency.

CONTRAINDICATIONS:

This product is contraindicated in patients with known hypersensitivity to any of the ingredients.

WARNINGS AND PRECAUTIONS:

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.
Folic acid is improper therapy in the treatment of pernicious anemia in that hematological remission can occur while neurological manifestations remain progressive. While prescribing this product for pregnant women, nursing mothers, or for women prior to conception, their medical condition and use of other drugs, herbs, and/or supplements should be considered.

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

ADVERSE REACTIONS:

Allergic sensitization has been reported following both oral and parenteral administration of folic acid. You should call your doctor for medical advice about side effects. To report a serious adverse event, call 1-855-899-4237.

DOSAGE AND ADMINISTRATION:

Before, during, and after pregnancy, take one tablet daily, or as prescribed by a physician.

HOW SUPPLIED:

Niron Komplete is supplied as a maroon tablet, imprinted “910”, in child-resistant bottles of 30 tablets, NDC 76331-910-30. Tamper evident by foil seal under cap.

Store at controlled room temperature 20° to 25°C (68° to 77°F); excursions permitted to 15° to 30°C (59° to 86°F). [See USP controlled room temperature].

Manufactured for:
WH Nutritionals
1000 N. West St., Suite 1200, #894
Wilmington, DE 19801
v1 Rev. 02/2012
Niron Komplete 
ascorbic acid, .alpha.-tocopherol, folic acid, cyanocobalamin, iron tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:76331-910
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 120 mg
.ALPHA.-TOCOPHEROL (.ALPHA.-TOCOPHEROL) .ALPHA.-TOCOPHEROL 20 [iU]
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
IRON (IRON) IRON 30 mg
Inactive Ingredients
Ingredient Name Strength
CELLULOSE, MICROCRYSTALLINE  
STARCH, CORN  
SILICON DIOXIDE  
MAGNESIUM STEARATE  
POLYETHYLENE GLYCOLS  
POLYVINYL ALCOHOL  
TITANIUM DIOXIDE  
TALC  
FD&C RED NO. 40  
FD&C BLUE NO. 1  
FD&C BLUE NO. 2  
Product Characteristics
Color red (maroon) Score no score
Shape CAPSULE (caplet) Size 21mm
Flavor Imprint Code 910
Contains         
Packaging
# Item Code Package Description
1 NDC:76331-910-30 30 TABLET (TABLET) in 1 BOTTLE, PLASTIC
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/25/2011
Labeler - WH Nutritionals, LLC (968642293)
Revised: 03/2013
 
WH Nutritionals, LLC



Hide