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Nicomide

Avion Pharmaceuticals, LLC

Nicomide


FULL PRESCRIBING INFORMATION: CONTENTS*




FULL PRESCRIBING INFORMATION

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.

Uses

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

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 750 mg
FOLIC ACID FOLIC ACID 500 ug
Zinc Oxide Zinc oxide 25 mg
CUPRIC OXIDE CUPRIC CATION 1.5 mg

Inactive Ingredients

Ingredient Name Strength
HYPROMELLOSES
cellulose, microcrystalline
MAGNESIUM STEARATE
STEARIC ACID
SILICON DIOXIDE
SHELLAC

Product Characteristics

Color Size Imprint Code Shape
WHITE 23 mm 342 OVAL

Packaging

# Item Code Package Description Marketing Start Date Marketing End Date
1 NDC:75854-342-60 60 in 1 BOTTLE

Marketing Information

Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
2012-06-15


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Be sure to consult your doctor before taking any medication!
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