{"dosage_and_administration":["DOSAGE AND ADMINISTRATION Usual adult dose is one or two tablets taken once or twice a day with or without food or as prescribed by a physician. HOW SUPPLIED 60 tablets NDC 49908-194-60 Store at 20ºC to 25ºC (68ºF to 77ºF), excursions permitted between 15ºC and 30ºC (between 59ºF and 86ºF). Brief exposure to temperatures up to 40ºC (104ºF) may be tolerated provided the mean kinetic temperature does not exceed 25ºC (77ºF); however, such exposure should be minimized. Manufactured for: Rochester Pharmaceuticals Rochester, NY 14624 1-866-458-1772 www.RochesterPharm.com 834979 10/12"],"effective_time":"20130407","id":"7ba487fc-f57d-4d8f-a8f0-d17aa55dbc86","openfda":{},"package_label_principal_display_panel":["​SUPPLEMENT FACTS Each oral tablet provides: Nicotinamide (Vitamin B3)……… 600 mg Azelaic Acid……………………………. 5 mg Zinc (Zinc Oxide)……………………. 10 mg Pyridoxine (Vitamin B6)…………. 5 mg Copper (Cupric Oxide)……………. 1.5 mg Folic Acid……………………………….. 500 mcg OTHER INGREDIENTS Microcrystalline cellulose, starch, purple coating (polyvinyl alcohol, macrogol/PEG, talc, titanium dioxide, FD&C Red #40, FD&C Blue #2), silicon dioxide, magnesium stearate. 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 that may be of benefit in patients with acne, including, but not limited to, suppression of antigen-induced lymphocytic transformation and inhibition of 3’, 5’-cyclic AMP phosphodiesterase. Nicotinamide has been demonstrated to block the inflammatory actions of iodides known to precipitate or exacerbate 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. Azelaic acid is a dietary constituent (e.g., in whole grain cereals and animal products) that has been shown to possess antimicrobial activity against Propionibacterium acnes and Staphylococcus epidermidis. The antimicrobial action may be attributable to inhibition of microbial cellular protein synthesis. A normalization of keratinization leading to an anticomedonal effect of azelaic acid may also contribute to its clinical activity. 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 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. Folic acid serves as an essential cofactor of 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 disorders. 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.","LABEL PANEL label1 label2 label3"],"precautions":["PRECAUTIONS Allergic sensitization has been reported rarely, following oral administration of folic acid."],"set_id":"0845fdba-97b7-426a-9ae1-930973260602","spl_product_data_elements":["Tri-Zel nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid NIACINAMIDE NIACINAMIDE AZELAIC ACID AZELAIC ACID ZINC OXIDE ZINC CATION PYRIDOXINE PYRIDOXINE CUPRIC OXIDE CUPRIC CATION FOLIC ACID FOLIC ACID CELLULOSE, MICROCRYSTALLINE STARCH, CORN POLYVINYL ALCOHOL POLYETHYLENE GLYCOLS TALC TITANIUM DIOXIDE FD&C RED NO. 40 FD&C BLUE NO. 2 SILICON DIOXIDE MAGNESIUM STEARATE R194"],"statement_of_identity":["RX ONLY Tri-zel (nicotinamide, azelaic acid, zinc, pyridoxine, copper, folic acid) Dietary Supplement As a dietary supplement for patients with acne vulgaris, rosacea, or other inflammatory skin disorders who are deficient in or at risk of deficiency in one or more of the components in Tri-zel Tablets. Tri-zel Tablets is a dietary supplement for oral administration. Each tablet is purple colored, oval-shaped, and embossed with “R194” on one side."],"version":"18","warnings":["WARNINGS As with any dietary supplement, if you are pregnant, nursing or taking medication, consult your doctor before use. Tri-zel Tablets is not formulated for use in children under 6 years of age. Folic acid above 1 mg daily may obscure pernicious anemia (hematologic remission may occur, while neurological manifestations remain progressive)."]}