Nicomide

Generic Name: niacinamide, folic acid, zinc oxide and cupric oxide
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.

Nicomide®

DESCRIPTION: Oval white tablet for oral administration of niacin, folate, zinc, and copper to supplement the diet. Tablets are debossed with “342” on one side and plain on the other.

Supplement Facts
Serving Size: 1 Tablet
 
Each Tablet Contains: % Daily Value
Niacin (as niacinamide) 750 mg 3,750%
Folate (as 926 mcg
Quatrefolic® ((6S)-5,-
methyltetrahydrofolate
glucosamine salt*) CAS 1181972-37-1)
500 mcg 125%
Zinc (as zinc oxide) 25 mg 167%
Copper (as cupric oxide) 1.5 mg 75%

The chemical structure for Quatrefolic® is:

OTHER INGREDIENTS: Hypromellose, Microcrystalline cellulose, Magnesium Stearate, Stearic acid, Silica, and pharmaceutical glaze.

Quatrefolic® ((6S)-5,-methyltetrahydrofolate, glucosamine salt) is the fourth generation folate which has enhanced stability as well as high water solubility and bioavailability.

INDICATIONS: Nicomide® tablets are indicated for patients who are deficient in, or at risk of deficiency in, one or more of the components in this product.

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

WARNING: Folate alone is improper treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient.

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

PRECAUTIONS: Large dose of Nicomide® should be administered with caution in patients with a history of jaundice, liver disease or diabetes mellitus.

Folate above 0.1 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).

Those with chronic liver failure and chronic renal failure should exercise extreme caution in the use of supplements containing copper.

If you are pregnant, nursing, or taking medication, consult your doctor before use.

Abnormal liver functions tests have been reported in persons taking daily doses of 500 mg or more of niacinamide. Folate intake should not exceed 250% of the Daily Value (1,000 mcg).

ADVERSE REACTIONS: Allergic sensitization has been reported rarely following oral and parental administration of Folate.

DOSAGE AND ADMINISTRATION: Usual adult dose is one tablet taken once or twice a day or prescribed by a physician.

HOW SUPPLIED: Nicomide® Tablets are supplied in bottles of 60 (75854-342-60).

STORAGE: Store between 15° - 30°C (59° - 86°F)

MANUFACTURED FOR: Avion Pharmaceuticals, LLC
Atlanta, GA 30350
1-888-61-AVION

*Quatrefolic® is a registered trademark of Gnosis, SpA. Covered by one or more claims of U.S. Patent # 7,947,662

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-342-60

Nicomide®

Dietary Supplement

with Niacinamide
Quatrefolic

60 Tablets

Rx Only

Avion
PHARMACEUTICALS

Nicomide 
niacinamide, folic acid, zinc oxide and cupric oxide tablet
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:75854-342
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 750 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 500 ug
ZINC OXIDE (ZINC OXIDE) ZINC OXIDE 25 mg
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 1.5 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES  
CELLULOSE, MICROCRYSTALLINE  
MAGNESIUM STEARATE  
STEARIC ACID  
SILICON DIOXIDE  
SHELLAC  
Product Characteristics
Color WHITE Score 2 pieces
Shape OVAL Size 23mm
Flavor Imprint Code 342
Contains         
Packaging
# Item Code Package Description
1 NDC:75854-342-60 60 TABLET (TABLET) in 1 BOTTLE
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
unapproved drug other 06/15/2012
Labeler - Avion Pharmaceuticals, LLC (965450542)
Revised: 09/2013
 
Avion Pharmaceuticals, LLC



Hide
(web5)