Nicotinamide

Tablet · Oral

Prescription (Rx) Copper-containing Intrauterine Device Standardized Chemical Allergen

Dosage and administration

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.

Warnings

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: 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.

Precautions

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

Label text from the FDA structured product label by Acella Pharmaceuticals, LLC (revised Feb 13, 2025). Long sections are shortened; the complete label is on DailyMed.

Active ingredients

Nicotinamide NDC products (1)

NDCStrength & formLabelerType
42192-374Niacinamide 750 mg/1; Zinc 27 mg/1; Folic Acid 850 ug/1; Copper 2 mg/1; Selenium 50 ug/1; Chromium 100 ug/1
Tablet
Acella Pharmaceuticals, LLCUNAPPROVED DRUG OTHER

Frequently asked questions

Who makes Nicotinamide?

Nicotinamide is listed by 1 labeler in the FDA NDC directory, including Acella Pharmaceuticals, LLC.