{"active_ingredient":["Ingredients: Each oral tablet provides: Nicotinamide, USP 750 mg Zinc Oxide, USP 25 mg Cupric Oxide 1.5 mg Folic Acid, USP 500 mcg"],"adverse_reactions":["Adverse Reactions: Allergic sensitization has been reported rarely following oral and parenteral administration of Folic Acid. At recommended doses, Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets is expected to be well tolerated. Gastrointestinal distress such as nausea or vomiting have been associated with the administration of Nicotinamide or zinc at doses greater than the recommended dose."],"contraindications":["Contraindications: Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets are contraindicated in patients with hypersensitivity to any of its components. Supplemental copper is contraindicated in those with Wilson’s disease (hepatolenticular degeneration) a disease of abnormal copper accumulation."],"dosage_and_administration":["Dosage and Administration: Usual adult dose is one tablet taken once or twice a day or as prescribed by a physician.","HOW SUPPLIED: Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets are supplied in bottles of 60, NDC# 42192-308-60.","Dosage: KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store between 15° - 30°C (59° - 86°F). All prescription substitutions using this product shall be made subject to state and federal statutes as applicable. Please note: this is not an Orange Book product and has not been subjected to FDA therapeutic equivalency or other equivalency testing. Each person recommending a prescription substitution using this product shall make such recommendations based on each such person’s professional opinion and knowledge, upon evaluating the active ingredients, incipients, inactive ingredients and chemical formulation information provided herein. Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4801","Manufactured for: Acella Pharmaceuticals, LLC Alpharetta, GA 30009 1-800-541-4801"],"drug_interactions":["Drug Interactions: Nicotinamide: The clearance of primidone and carbamazepine may be reduced with the concomitant use of Nicotinamide. Zinc Oxide: The absorption of quinolones or tetracycline may be decreased with the concomitant use of zinc. Cupric Oxide: Concomitant use of penicillamines and copper can cause decreased absorption of both substances. Pregnancy: Large doses of Nicotinamide, zinc or copper should be avoided in pregnancy. Nursing Mothers: Caution should be exercised when using Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets in nursing mothers. Pediatrics: Safety and effectiveness of Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets in pediatric patients have not been established. Geriatrics: Clinical studies of Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets have not been performed to determine whether elderly subjects respond differently than younger subjects. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy. Adverse Reactions: Allergic sensitization has been reported rarely following oral and parenteral administration of Folic Acid. At recommended doses, Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets is expected to be well tolerated. Gastrointestinal distress such as nausea or vomiting have been associated with the administration of Nicotinamide or zinc at doses greater than the recommended dose. Nicotinamide: dizziness, headache, hyperglycemia, nausea, vomiting diarrhea, elevations in liver function tests, hepatotoxicity, blurred vision, flushing, rash."],"effective_time":"20180424","geriatric_use":["Geriatrics: Clinical studies of Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets have not been performed to determine whether elderly subjects respond differently than younger subjects. In general dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal or cardiac function, and of concomitant disease or other drug therapy."],"health_claim":["Nicotinamide is a water-soluble component of the vitamin B complex group. In vivo, Nicotinamide is incorporated into Nicotinamide adenine dinucleotide (NAD) and Nicotinamide adenine dinucleotide phosphate (NADP). NAD and NADP function as coenzymes in a wide variety of enzymatic oxidation-reduction reactions essential for tissue respiration, lipid metabolism and glycogenolysis. Nicotinamide has demonstrated anti-inflammatory actions which may be of benefit in patients with inflammatory acne vulgaris, including but not limited to, suppression of antigen induced-lymphocytic transformation and inhibition of 3’ – 5’ cyclic AMP phosphodiesterase. Nicotinamide has demonstrated the ability to block the inflammatory actions of iodides known to precipitate or exacerbate inflammatory acne. Nicotinamide lacks the vasodilator, gastrointestinal, hepatic and hypolipemic actions of nicotinic acid or niacin. As such, Nicotinamide has not been shown to produce the flushing, itching and burning sensations of the skin as is commonly seen when large doses of nicotinic acid or niacin are administered orally (see Adverse Reactions section). Zinc has been shown to inhibit the inflammatory polymorphonuclear leukocyte chemotaxis in acne patients. Zinc has also demonstrated an inhibitory effect on the lipase of the three Propionibacterium species found in human pilosebaceous follicles. Patients with inflammatory acne have been shown to have significantly lower serum zinc levels than matched healthy controls. Copper is an essential trace mineral in human nutrition. Although rare, copper deficiency has been induced by supplemental zinc therapy. Chronic zinc supplementation has been shown to reduce the intestinal absorption and utilization of copper, which can induce signs of copper deficiency in some patients. Symptoms of copper deficiency include anemia and decreased activity of cytochrome c oxidase. Heartbeat irregularities have also been reported in some studies. The biphasic delivery system is designed to address this issue by delivering supplemental copper with zinc in a manner that minimizes the potential for competitive antagonism in absorption. Folic Acid serves as an essential cofactor for the biosynthesis of thymidine and purine nucleotides required for normal cellular DNA synthesis. Deficiencies of folic acid have been demonstrated to occur in some cutaneous inflammatory disorders.","Indications: Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets are indicated for patients who are deficient in, or at risk of deficiency in, one or more of the components in this product."],"id":"6a9c6a8e-d26a-369d-e053-2a91aa0a5c33","inactive_ingredient":["Inactive Ingredients: magnesium stearate, stearic acid, silica and pharmaceutical glaze coating. The biphasic delivery of Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets minimizes the potential for competitive antagonism in absorption of its ingredients. The biphasic delivery system facilitates the immediate release of 750 mg Nicotinamide, 1.5 mg Cupric Oxide, and 500 mcg Folic Acid, as well as, the delayed action of 25 mg Zinc Oxide. The biphasic delivery system also minimizes the potential for drug interaction induced deficiency states and impaired absorptions of other therapeutic agents."],"nursing_mothers":["Nursing Mothers: Caution should be exercised when using Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets in nursing mothers."],"openfda":{},"package_label_principal_display_panel":["Package Labeling: Label"],"pediatric_use":["Pediatrics: Safety and effectiveness of Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets in pediatric patients have not been established."],"precautions":["PRECAUTIONS Precautions: General: Large doses of Nicotinamide should be administered with caution in patients with a history of jaundice, liver disease or diabetes mellitus. Folic Acid above 0.1 mg daily may obscure pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive). Those with chronic liver failure and chronic renal failure should exercise extreme caution in the use of supplements containing copper."],"pregnancy":["Pregnancy: Large doses of Nicotinamide, zinc or copper should be avoided in pregnancy."],"set_id":"6a9c55a3-bc73-1eb9-e053-2a91aa0a3e54","spl_product_data_elements":["Nicotinamide NIACINAMIDE, ZINC OXIDE, CUPRIC OXIDE, FOLIC ACID HYPROMELLOSE, UNSPECIFIED MAGNESIUM STEARATE STEARIC ACID SILICON DIOXIDE SHELLAC NIACINAMIDE NIACINAMIDE ZINC OXIDE ZINC CATION CUPRIC OXIDE CUPRIC CATION FOLIC ACID FOLIC ACID OBLONG BP132"],"statement_of_identity":["Nicotinamide Zinc Oxide, Cupric Oxide, Folic Acid Tablets Prescription Only Dietary Supplement DESCRIPTION Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets for oral administration are white-colored tablets, embossed with “BP132” on one side and plain on the other.","DESCRIPTION Nicotinamide, Zinc Oxide, Cupric Acid, Folic Acid Tablets for oral administration are white-colored tablets, embossed with “BP132” on one side and plain on the other."],"version":"1","warnings":["WARNINGS Folic Acid alone is improper treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient."]}