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).
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.
OTHER INGREDIENTS: Crosscarmellose Sodium,
Magnesium Stearate, Methocel K, Microcrystalline Cellulose,
Silicon Dioxide and Stearic Acid. Coating contains: Hydroxypropyl
Methylcellulose, Titanium Dioxide and Triacetin
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.
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.]
*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.
You may report side effects to Avion Pharmaceuticals, LLC at
1-888-612-8466 or to the FDA at
1-800-FDA-1088.
Please click here for full
Prescribing Information, including Boxed Warning.
