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Rx Only Dietary Supplement
DESCRIPTION: Oval white tablet for oral administration
of Niacinamide, 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:
Niacinamide
% Daily Value
750 mg
3,750%
500 mcg
125%
Folate (as 926 mcg
Quatrefolic® ((6S)-5,-Methyltetrahydrofolate
Glucosamine Salt, CAS # 1181972-37-1)
molar equivalent to 500 mcg of Folic Acid
Zinc (as Zinc Oxide)
25 mg
167%
Copper (as Cupric Oxide) 1.5 mg
75%
OTHER INGREDIENTS: Methocel K, Lactose Anhydrous,
Silicon Dioxide, Stearic Acid, Microcrystalline Cellulose,
Magnesium Stearate, Pharmaceutical Coating.
INDICATIONS: Nicomide® tablets are indicated for patients
who are deficient, 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® should be
administered with caution in patients with a history
of jaundice, liver disease, or diabetes. Patients with
chronic liver and / or renal failure should exercise
extreme caution in taking prescribed supplements
containing Copper. Abnormal liver function tests
have been reported in persons taking a daily dose
of 500mg or more of Niacinamide. Folic acid in doses
above 1.0mg daily may obscure pernicious anemia in
that hematologic remission can occur while neurological
manifestations remain progressive. Folic acid intake
should not exceed 250% of the recommended Daily
Value (1.0mg), unless physician or healthcare provider
explicitly prescribes otherwise.
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: Folic acid alone is improper
treatment of pernicious anemia and other
megaloblastic anemias where Vitamin
B12 is deficient.
PREGNANT WOMEN & NURSING
MOTHERS: If you are pregnant, nursing
or taking medication please consult with
your physician or healthcare provider prior
to using Nicomide®. Physicians should
administer Nicomide® with extreme
caution to patients who are pregnant,
nursing or taking medication. Prior to
prescribing Nicomide® (to pregnant
women, nursing mothers or patients on
medication), physicians and healthcare
providers must consider the patient’s
medical history and any drug(s), herb(s)
and / or other medication consumption.
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 daily, or as prescribed
by physician.
HOW SUPPLIED: NICOMIDE® Rx Dietary
Supplement is supplied in bottles of 60
tablets (75854-342-60). The listed
product is not a National Drug Code.
Instead, Avion Pharmaceuticals has
assigned a product code formatted
according to standard industry practice
to meet the formatting requirements of
pharmacy and healthcare insurance
computer systems.
STORAGE: Store between 15° - 30°C
(59° - 86°F)
MANUFACTURED FOR:
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
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
CAS# 1181972-37-1
Nicomide® is a registered trademark of
Acella Pharmaceuticals, LLC. Under
license from Acella Pharmaceuticals, LLC.
All rights reserved.
Rev. 0514