Complete SPL Sections#
DESCRIPTION:
DESCRIPTION SECTION
Full Prescribing Information: Each Serving Size of 2 caplets contain: Vitamin A (as Retinyl Acetate)................................................... 3000 mcg RAE Vitamin C (as Ascorbic Acid)............................................................... 500 mg Vitamin D (as Cholecalciferol).......................................... 3 27.5 mcg (1100 IU) Vitamin E (as DL-alpha Tocopheryl Acetate)........................................... 90 mg Thiamin (as Thiamine Mononitrate)....................................................... 6.5 mg Riboflavin ............................................................................................. 6.7 mg Niacin (as Niacinamide)......................................................................... 45 mg Vitamin B6 (as Pyridoxine HCl)............................................................... 12 mg Folate 1700 mcg DFE (as L-5-Methyltetrahydrofolate calcium salt).........(1000 mcg as L-Methyfolate) Vitamin B12 (as Methylcobalamin)....................................................... 26 mcg Biotin ................................................................................................ 200 mcg Pantothenic Acid (as Calcium Pantothenate)........................................... 30 mg Calcium (as Calcium Carbonate)...........................................................150 mg Iron (as Ferrous Fumarate)......................................................................18 mg Iodine (as Potassium Iodide)................................................................50 mcg Magnesium (as Magnesium Oxide)........................................................ 75 mg Zinc (as Zinc Gluconate)......................................................................... 30 mg Selenium (as Selenomethionine)...........................................................60 mcg Copper (as Copper Oxide)....................................................................... 2 mg Manganese (as Manganese Sulfate).......................................................1.5 mg Chromium (as Chromium Polynicotinate)..............................................75 mcg Molybdenum (as Sodium Molybdate)................................................... 50 mcg Potassium (as Potassium Chloride)....................................................... 49 mg Boron (as Boron Citrate)...................................................................... 50 mcg Other Ingredients: Microcrystalline Cellulose, Silicon Dioxide, Crospovidone, Magnesium Stearate, Coating:(Sodium Carboxymethylcellulose, Dextrose Monohydrate, Titanium Dioxide, Dextrin, Purified Stearic Acid, FD&C Yellow #6/Sunset Yellow FCF Aluminum Lake).
INDICATIONS:
INDICATIONS & USAGE SECTION
Folitin-Z TM is indicated for the treatment of iron deficiency anemia and folate deficiency as in extended convalescence, menorrhagia, pregnancy, puberty, excessive blood loss, and advanced age. Also for the treatment of the condition in which iron deficiency and vitamin C deficiency occurs together, along with a deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.
CONTRAINDICATIONS:
CONTRAINDICATIONS SECTION
This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.
WARNING:
WARNINGS SECTION
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 poison control center immediately. Administration of folic acid alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.
OVERDOSE:
OVERDOSAGE SECTION
Iron: Signs and Symptoms: Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness, and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Folitin-Z TM should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this and all other drugs out of reach of children.
DOSAGE AND ADMINISTRATION:
DOSAGE & ADMINISTRATION SECTION
Adults (persons over 12 years of age) Two (2) Folitin-Z TM caplet daily, between meals or as directed by a physician. Do not administer to children under the age of 12.
HOW SUPPLIED:
HOW SUPPLIED SECTION
Folitin-Z TM are yellow with slightly brown speckled, coated caplets. Bottles contain 60 caplets – NDC 59088-181-58. Dispense in a tight, light-resistant container as defined in the USP/NF with a child-resistant closure.
STORAGE:
STORAGE AND HANDLING SECTION
Do not use if bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20o to 25oC (68o to 77oF). [See USP]. Protect from light and moisture and avoid excessive heat. To report a serious adverse event or to obtain product information, contact 1-877-921-7873.
Chronocap
SPL UNCLASSIFIED SECTION
Folitin-Z TM
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 Questions? Call toll-free: 1-877-921-7873
