FDA Label for Nicomide
View Indications, Usage & Precautions
Nicomide Product Label
The following document was submitted to the FDA by the labeler of this product Avion Pharmaceuticals, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
| 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) | 100% | |
| Selenium (Selenium Amino Acid Chelate) | 71% | |
| Chromium (Chromium Amino Acid Chelate) | 83% | |
| † Daily Value (DV) not established. |
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
* Please review the disclaimer below.