Nicomide: Package Insert and Label Information

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

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

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

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 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

PRINCIPAL DISPLAY PANEL -- 30 capsules
(click image for full-size original)
NICOMIDE
niacinamide, zinc glycinate, folic acid, cupric oxide, selenium and chromium tablet
Product Information
Product Type Item Code (Source) NDC:75854-343
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 750 mg
ZINC GLYCINATE (ZINC CATION) ZINC GLYCINATE 27 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 500 ug
CUPRIC OXIDE (CUPRIC CATION) CUPRIC CATION 2 mg
SELENIUM (SELENIUM) SELENIUM 50 ug
CHROMIUM (CHROMIUM) CHROMIUM 100 ug
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSE 2208 (100 MPA.S)
ANHYDROUS LACTOSE
SILICON DIOXIDE
STEARIC ACID
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
HYPROMELLOSE, UNSPECIFIED
TRIACETIN
TITANIUM DIOXIDE
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 23mm
Flavor Imprint Code 342
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75854-343-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 12/08/2014
Labeler — Avion Pharmaceuticals, LLC (040348516)
Establishment
Name Address ID/FEI Operations
Avion Pharmaceuticals, LLC 040348516 manufacture (75854-343)

Revised: 01/2020 Avion Pharmaceuticals, LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.