Prescription Drugs

CLINICAL PHARMACOLOGY No information provided.

DESCRIPTION ADVANCED FORMULA ZENATE® Prenatal Multivitamin/ Mineral Supplement Tablets WARNING Accidental overdose of iron-containing products is a leading cause of fetal poisoning in children under six. Keep this product out of the reach of children. In case of accidental overdose, call a doctor or poison control center immediately. Each film-coated tablet contains: Vitamins: A* 3000 I.U. D (as cholecalciferol) 400 I.U. E (as dl-alpha tocopheryl acetate) 10 I.U. C (ascorbic acid) 70 mg Folic Acid 1 mg B1 (as thiamine mononitrate) 1.5 mg B2 (riboflavin) 1.6 mg B6 (as pyridoxine hydrochloride) 2.2 mg B12 (cyanocobalamin) 2.2 µg Niacin (as niacinamide) 17mg Minerals: Calcium (from calcium carbonate) 200 mg Iodine (from potassium iodide) 175 µg Iron (from ferrous fumarate) 65 mg Magnesium (from magnesium oxide) 100 mg Zinc (from zinc oxide) 15 mg * Input as retinyl palmitate and beta-carotene Inactive Ingredients: Amorphous Precipitated Silica, Aqueous Shellac, Croscarmellose Sodium, Crospovidone, Hydrogenated Soybean Oil, Hydrogenated Castor Oil, Hydroxypropyl Cellulose, Hydroxylpropyl Methylcellulose, Magnesium Stearate, Polyethylene Glycol, Polysorbate 80, Powdered Cellulose, Pregelatinized Starch and Titanium Dioxide.

INDICATIONS As a dietary adjunct in nutritional stress associated with periconception, pregnancy and lactation. DOSAGE AND ADMINISTRATION One tablet daily or as directed by physician. HOW SUPPLIED Advanced Formula ZENATE® Tablets are white, film-coated scored, capsule-shaped tablets debossed "SOLVAY" on one side and "1472" on the other and supplied in child-resistant unit dose foil pouches. Unit dose pack of 30 tablets (1 x 30) NDC 0032-1472-26. Advanced Formula ZENATE® Tablets are supplied in child-resistant unit dose packaging. Do not repackage. Store at controlled room temperature: 15°- 30° C (59°- 86° F) CAUTION: Federal Law prohibits dispensing without prescription.

PATIENT INFORMATION Do not remove tablets from original unit-dose, child-resistant packaging until use.

OVERDOSE No information provided. CONTRAINDICATIONS This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

SIDE EFFECTS Allergic sensitization has been reported following both oral and parenteral adiministration of folic acid. DRUG INTERACTIONS No information provided.

WARNINGS See BOXED WARNING. PRECAUTIONS Folic acid may obscure pernicious anemia, in that hematologic remission can occur while neurologic manifestations remain progressive.