Label: NICOTINAMIDE tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated May 28, 2021

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    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.

    Supplement Facts
    Serving Size: 1 Tablet
    Amount per serving: % Daily Value
    Nicotinamide750 mg4700%
    Zinc (as Zinc Bisglycinate Chelate)*27 mg245%
    Folate (as (6S)-N5-Methyl- tetrahydrofolic Acid Calcium Salt850 mcg DFE210%
    (Equivalent to 500 mcg Folic Acid, USP))
    Copper (as Cupric Oxide)2 mg220%
    Selenium (Selenium Amino Acid Chelate)50 mcg90%
    Chromium (Chromium Amino Acid Chelate)100 mcg290%

    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

    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

  • 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.

  • DOSAGE & 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.

  • PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

    C:\Users\admin\Desktop\nicotinamide\nicotinamide-label.jpg
  • INGREDIENTS AND APPEARANCE
    NICOTINAMIDE 
    nicotinamide tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:42192-374
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4) NIACINAMIDE750 mg
    ZINC (UNII: J41CSQ7QDS) (ZINC - UNII:J41CSQ7QDS) ZINC27 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID850 ug
    COPPER (UNII: 789U1901C5) (COPPER - UNII:789U1901C5) COPPER2 mg
    SELENIUM (UNII: H6241UJ22B) (SELENIUM - UNII:H6241UJ22B) SELENIUM50 ug
    CHROMIUM (UNII: 0R0008Q3JB) (CHROMIUM - UNII:0R0008Q3JB) CHROMIUM100 ug
    Inactive Ingredients
    Ingredient NameStrength
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    HYPROMELLOSE 2208 (100 MPA.S) (UNII: B1QE5P712K)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:42192-374-6060 in 1 BOTTLE
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    Dietary Supplement05/25/2021
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    imprint
    shape
    size (solid drugs)23 mm
    scoring1
    Labeler - Acella Pharmaceuticals, LLC (825380939)
    Registrant - Acella Pharmaceuticals, LLC (825380939)