NICOMIDE- niacinamide, zinc glycinate, folic acid, cupric oxide, selenium and chromium tablet

Nicomide by

Drug Labeling and Warnings

Nicomide by is a Other medication manufactured, distributed, or labeled by Avion Pharmaceuticals, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

STATEMENT OF IDENTITY

Rx Only Dietary Supplement

DESCRIPTION

Nicomide® Tablets is a prescription dietary supplement for oral administration, specifically formulated for the dietary management of patients with unique nutritional needs who require increased levels of one or more of the ingredients in this product. Each white-colored, oval-shaped tablet is debossed with “342” on one side and blank on the other.

† Daily Value (DV) not established.
Supplement Facts; Serving Size: 1 Tablet
Amount per serving:	% Daily Value
Niacinamide	750 mg	†
Zinc (as Zinc Bisglycinate Chelate)*	27 mg	180%
Folate (as (6S)-N5-Methyltetrahydrofolic Acid Calcium Salt)	500 mcg	125%
Copper (as Cupric Oxide)	2 mg	100%
Selenium (Selenium Amino Acid Chelate)	50 mcg	71%
Chromium (Chromium Amino Acid Chelate)	100 mcg	83%

OTHER INGREDIENTS

Methocel K, Lactose Anhydrous, Silicon Dioxide, Stearic Acid, Microcrystalline Cellulose, Magnesium Stearate, Hydroxypropyl Methylcellulose, Triacetin, and Titanium Dioxide.

INDICATIONS

Nicomide® Tablets is indicated for use as a dietary supplement for patients who are deficient in, or who are at risk for deficiency in one or more of the ingredients in this product.

CONTRAINDICATIONS

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

PRECAUTIONS

PRECAUTIONS

Large doses of Nicomide® Tablets should be administered with caution in patients with a history of jaundice, liver disease, or diabetes. Patients with chronic liver failure and/or renal failure should exercise extreme caution in taking prescribed supplements containing copper.

Folic acid alone is improper treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid especially in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission may occur while neurological manifestations remain progressive.

THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE, OR PREVENT ANY DISEASE.

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

WARNINGS

WARNINGS

If you are pregnant, nursing, or taking medication, consult your doctor before use. Use only under the advice and supervision of a physician if you have a history of jaundice, liver disease or diabetes. Abnormal liver function 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).

PREGNANCY & NURSING MOTHERS

Nicomide® Tablets is not indicated for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. Physicians and medical practitioners should administer Nicomide® Tablets with caution to patients who are pregnant, lactating and/or taking medication.

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

DOSAGE & ADMINISTRATION

DOSAGE AND ADMINISTRATION

Take 1-2 tablets daily, as a dietary supplement, as directed by your physician.

HOW SUPPLIED

Nicomide® Tablets are white-colored, oval-shaped tablets debossed on one side with “342”, and are supplied in bottles of 60 tablets (75854-343-60). The listed product number is not a National Drug Code. Instead, Avion has assigned a product code formatted according to standard industry practice in order to comply with 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.]

MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
1-888-61-AVION
Rev. 1117-01

*Subject to one or more claims of U.S. Patent Nos. 7,582,418, 7,838,042 and 8,425,956.

Nicomide® is a registered trademark of Acella Pharmaceuticals, LLC. Under license from Acella Pharmaceuticals, LLC. All rights reserved.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

75854-343-60

Nicomide®

Dietary Supplement

60 Tablets
Rx Only

Avion
PHARMACEUTICALS

INGREDIENTS AND APPEARANCE

NICOMIDE 
niacinamide, zinc glycinate, folic acid, cupric oxide, selenium and chromium tablet

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:75854-343
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	750 mg
ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37)	ZINC GLYCINATE	27 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	500 ug
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg
SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B)	SELENIUM	50 ug
CHROMIUM (UNII: 0R0008Q3JB) (CHROMIUM - UNII:0R0008Q3JB)	CHROMIUM	100 ug

Inactive Ingredients
Ingredient Name	Strength
HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)
ANHYDROUS LACTOSE (UNII: 3SY5LH9PMK)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
STEARIC ACID (UNII: 4ELV7Z65AP)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
MAGNESIUM STEARATE (UNII: 70097M6I30)
HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)
TRIACETIN (UNII: XHX3C3X673)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:75854-343-60	60 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		12/08/2014

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
scoring	1
shape
size (solid drugs)	23 mm
imprint

Labeler - Avion Pharmaceuticals, LLC (040348516)

Establishment
Name	Address	ID/FEI	Business Operations
Avion Pharmaceuticals, LLC		040348516	manufacture(75854-343)