Nicotinamide: Package Insert and Label Information

NICOTINAMIDE — niacinamide, zinc, folic acid, copper, selenium and chromium tablet
Acella Pharmaceuticals, LLC

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
Nicotinamide 750 mg 4700%
Zinc (as Zinc Bisglycinate Chelate)* 27 mg 245%
Folate (as (6S)-N5-Methyl- tetrahydrofolic Acid Calcium Salt 850 mcg DFE 210%
(Equivalent to 500 mcg Folic Acid, USP))
Copper (as Cupric Oxide) 2 mg 220%
Selenium (Selenium Amino Acid Chelate) 50 mcg 90%
Chromium (Chromium Amino Acid Chelate) 100 mcg 290%

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.

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 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

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NICOTINAMIDE
nicotinamide tablet
Product Information
Product Type Item Code (Source) NDC:42192-374
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
NIACINAMIDE (NIACINAMIDE) NIACINAMIDE 750 mg
ZINC (ZINC) ZINC 27 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 850 ug
COPPER (COPPER) COPPER 2 mg
SELENIUM (SELENIUM) SELENIUM 50 ug
CHROMIUM (CHROMIUM) CHROMIUM 100 ug
Inactive Ingredients
Ingredient Name Strength
CROSCARMELLOSE SODIUM
MAGNESIUM STEARATE
HYPROMELLOSE 2208 (100 MPA.S)
MICROCRYSTALLINE CELLULOSE
SILICON DIOXIDE
STEARIC ACID
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
Product Characteristics
Color WHITE Score no score
Shape OVAL Size 23mm
Flavor Imprint Code 342
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:42192-374-60 60 TABLET in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
Dietary Supplement 05/25/2021
Labeler — Acella Pharmaceuticals, LLC (825380939)
Registrant — Acella Pharmaceuticals, LLC (825380939)

Revised: 05/2021 Acella Pharmaceuticals, LLC

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