Nicotinamide

RX Only

Dietary Supplement

DESCRIPTION: Nicotinamide 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: Nicotinamide 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 Nicotinamide 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.

PREGNANCY & NURSING MOTHERS:

Nicotinamide Tablets is not indicated for use as a prenatal/postnatal multivitamin for lactating and nonlactating mothers. Physicians and medical practitioners should administer Nicotinamide 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: Nicotinamide Tablets are white-colored, oval-shaped tablets debossed on one side with “342”, and are supplied in bottles of 60 tablets (42192-374-60). The listed product number is not a National Drug Code. Instead, Acella 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:

Acella Pharmaceuticals, LLC Alpharetta, GA 30005

1-800-541-4802

L-0289 Rev 0321-01

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