{"adverse_reactions":["Adverse Reactions: Allergic sensitization has been reported rarely following oral and parenteral administration of Folic Acid. Nicotinamide ZCF is expected to be well tolerated at recommended doses. At doses greater than the recommended dose gastrointestinal distress such as nausea or vomiting have been associated with the administration of nicotinamide or zinc. Nicotinamide: Dizziness, headache, hyperglycemia, nausea, vomiting, diarrhea, elevations in liver function tests, hepatotoxicity, blurred vision, flushing, rash. Store between 15°-30°C (59°-86°F). Manufactured for: River's Edge Pharmaceuticals, LLC. Suwanee, GA 30024 Rev. 07/08 344-11"],"clinical_pharmacology":["Clinical Pharmacology: 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."],"contraindications":["Contraindications: Nicotinamide ZCF is 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."],"description":["Description: Nicotinamide ZCF Tablets for oral administration are white-colored tablets, embossed with “TL” on one side and “032” on the other."],"dosage_and_administration":["Dosage & Administration: Usual adult dose is one tablet taken once or twice a day or as prescribed by a physician."],"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 penicillamine and copper can cause decreased absorption of both substances."],"effective_time":"20091210","geriatric_use":["Geriatrics: Clinical studies of Nicotinamide ZCF 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."],"how_supplied":["How Supplied: Nicotinamide ZCF is supplied in bottles of 60’s, NDC 68032-344-60 . Each oral tablet provides: Nicotinamide, USP 750 mg Zinc Oxide, USP 25 mg Cupric Oxide 1.5 mg Folic Acid, USP 500 mcg"],"id":"96dda94d-7cc5-42ea-9401-455c5df7cb08","inactive_ingredient":["Inactive Ingredients: Copovidone, Dicalcium Phosphate, Ethylcellulose, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Pharmaceutical Glaze, Silica, Sodium Lauryl Sulfate, Titanium Dioxide and Triacetin. The biphasic delivery of Nicotinamide ZCF 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 sustained release 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."],"indications_and_usage":["Indications & Usage: Nicotinamide ZCF is indicated for non-pregnant patients with acne vulgaris, acne rosacea or other inflammatory skin disorders who are deficient in, or at risk of deficiency in, one or more of the components of Nicotinamide ZCF ."],"nursing_mothers":["Nursing Mothers: Caution should be exercised when using Nicotinamide ZCF in nursing mothers."],"openfda":{},"package_label_principal_display_panel":["Package Label: Each tablet contains: Nicotinamide USP, Zinc Oxide USP, Copper (Cupric Oxide), Folic Acid USP, Copovidone, Dicalcium Phosphate, Ethylcellulose, Hypromellose, Magnesium Silicate, Magnesium Stearate, Microcrystalline Cellulose, Mineral Oil, Pharmaceutical Glaze, Silica, Sodium Lauryl Sulfate, Titanium Dioxide and Triacetin. Manufactured for: River's Edge Pharmaceuticals, LLC. Suwanee, GA 30024 Indications and Usage: Indicated for non-pregnant patients with acne vulgaris, acne rosacea or other inflammatory skin disorders who are deficient in, or at risk of deficiency in, one or more of the components of Nicotinamide ZCF. Dosage: Adults—One tablet once or twice a day or as directed by a physician. Storage: Store between 15°-30°C (59°-86°F). Keep tightly closed. Description: White tablet with “TL” on one side, “032” on the other. NDC# 68032-344-60. PLEASE REFER TO PACKAGE INSERT FOR WARNINGS AND PRECAUTIONS. Keep out of the reach of children. Insert Label"],"pediatric_use":["Pediatrics: Safety and effectiveness of Nicotinamide ZCF in pediatric patients have not been established."],"precautions":["Precautions: General: Patients with a history of jaundice, liver disease, or diabetes mellitus should exercise caution in the use of high doses of nicotinamide. Folic Acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. Extreme caution should be exercised in the use of supplements containing copper in patients with chronic liver failure and chronic renal failure."],"pregnancy":["Pregnancy: Large doses of nicotinamide, zinc, or copper should be avoided in pregnancy."],"set_id":"ae9a32ca-f012-40ca-aae2-dee40758f903","spl_product_data_elements":["NICOTINAMIDE ZCF NICOTINAMIDE ZCF, Nicotinamide 750mg, Zinc Oxide 25mg, Cupric Oxide 1.5mg, Folic Acid 500mcg NIACINAMIDE NIACINAMIDE ZINC OXIDE ZINC OXIDE CUPRIC OXIDE CUPRIC OXIDE FOLIC ACID FOLIC ACID white-colored TL;032"],"version":"3","warnings":["Warnings: Folic Acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient."]}