PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 30 Tablet Blister Pack Carton 0642-0094-30 Vitafol Nano Preconception and Prenatal Supplement METAFOLIN Once daily tablet 1 mg Folate (400 mcg as Folic Acid and 600 mcg as Metafolin 1000 IU Vitamin D Essential nutrients in a tolerable form without DHA ACTUAL SIZE Rx Unit Dose Pack/30 Tablets U.S. PATENTED
ADVERSE REACTIONS SECTION.
ADVERSE REACTIONS Adverse reactions have been reported with specific vitamins and minerals, but generally at doses substantially higher than those in Vitafol-Nano. However, allergic and idiosyncratic reactions are possible at any dose. Reported adverse events include skin ailments, gastrointestinal complaints, glucose abnormalities, and visual problems.
INDICATIONS & USAGE SECTION.
USAGE Vitafol-Nano provides vitamin and mineral supplementation prior to conception, throughout pregnancy, and during the postnatal period for the lactating and non-lactating mother.
DOSAGE & ADMINISTRATION SECTION.
DIRECTIONS FOR USE Before, during and after pregnancy, one tablet daily, or as directed by a physician.
SPL UNCLASSIFIED SECTION.
Rx Manufactured for EVERETT LABORATORIES, INC. Chatham, NJ 07928 You should call your doctor for medical advice about serious adverse events. To report a serious adverse event or obtain product information, contact 1-877-324-9349 Metafolin is a trademark of Merck KGaA, Darmstadt, Germany U.S. Patent No. 6,441,168B1; 5,997,915; 6,254,904; 6,808,725; 7,172,778 and 7,674,490 (Rev. 03/14)
HOW SUPPLIED SECTION.
HOW SUPPLIED Vitafol-Nano is available as a light blue, round tablet imprinted with "94" on one side. Available in Box of Unit-Dose pack of 30 (2 child resistant blister cards of 15 tablets), 0642-0094-30 and as professional samples, 0642-0094-03. Store at room temperature, approximately 15-30C (59-86F), avoid excessive heat, light and moisture.
BOXED WARNING SECTION.
WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call a doctor or a Poison Control Center immediately,
COMPOSITION Amount per Tablet: VITAMINS AND MINERALS: Vitamin D (as cholecalciferol) 1000 IU Vitamin B6 (as pyridoxine hydrochloride) 2.5 mg Folate (as Folic acid USP 0.4 mg and L-methylfolate calcium 0.6 mg, as Metafolin CAS# 151533-22-1) 1 mg Vitamin B12 (as cyanocobalamin) 12 mcg Iron (as ferrous fumarate) 18 mg Iodine (as potassium iodide) 150 mcg Other Ingredients Microcrystalline cellulose, hydroxypropylcellulose, modified food starch, croscarmellose sodium, magnesium stearate, sucrose, silicon dioxide, dibasic calcium phosphate, polyvinyl alcohol, titanium dioxide (as color), polyethylene glycol, talc, sodium ascorbate, medium chain triglycerides, dl-alpha-tocopherol, sucralose, FD&C Blue #2 Aluminum Lake.
CONTRAINDICATIONS Vitafol-Nano is contraindicated in patients with hypersensitivity to any of its components or color additives. Folic acid is contraindicated in patients with untreated and uncomplicated pernicious anemia, and in those with anaphylactic sensitivity to folic acid. Iron therapy is contraindicated in patients with hemochromatosis and patients with iron storage disease or the potential for iron storage disease due to chronic hemolytic anemia (e.g., inherited anomalies of hemoglobin structure or synthesis and/or red cell enzyme deficiencies, etc.), pyridoxine responsive anemia, or cirrhosis of the liver. Cyanocobalamin is contraindicated in patients with sensitivity to cobalt or to cyanocobalamin (vitamin B12).
WARNINGS/PRECAUTIONS Vitamin D supplementation should be used with caution in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. High doses of vitamin D can lead to elevated levels of calcium that reside in the blood and soft tissues. Bone pain, high blood pressure, formation of kidney stones, renal failure, and increased risk of heart disease can occur. Prolonged use of iron salts may produce iron storage disease. Folic acid, especially in doses above 0.1 mg daily, may obscure pernicious anemia, in that hematologic remission may occur while neurological manifestations remain progressive. The use of folic acid doses above 1 mg daily may precipitate or exacerbate the neurological damage of vitamin B12 deficiency. Avoid Overdosage. Keep out of the reach of children. DRUG INTERATIONS High doses of folic acid may result in decreased serum levels of the anticonvulsant drugs; carbamazepine, fosphenytoin, phenytoin, phenobarbitol, valproic acid. Folic acid may decrease a patient's response to methotrexate. Vitamin D supplementation should not be given with large amounts of calcium in those with hypercalcemia or conditions that may lead to hypercalcemia such as hyperparathyroidism and those who form calcium-containing kidney stones. Consult appropriate references for additional specific vitamin-drug interactions. Information for Patients Patients should be counseled to disclose all medical conditions, including use of all medications, vitamins and supplements, pregnancy, and breastfeeding. Pediatric Use Not for pediatric use.