STORAGE AND HANDLING SECTION.

STORAGE:. Do not use if the bottle seal is broken. KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN. Store at controlled room temperature 20 to 25C (68 to 77F). [See USP]. Protect from light and moisture and avoid excessive heat. To report serious adverse event or to obtain product information, contact 1-877-921-7873.

ADVERSE REACTIONS SECTION.

Adverse Reactions:. Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation)occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Ribotin-E(TM) after meals may control occasional gastrointestinal disturbances. Ribotin-E(TM) is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. 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 contraindication, as folic acid may obscure its signs and symptoms.

DESCRIPTION SECTION.

DESCRIPTION:. Full Prescribing Information:Each Serving Size of caplets contain: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). Supplement.

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. Adults (persons over 12 years of age) Two (2) Ribotin-E TM caplets daily, between meals or as directed by physician. Do not administer to children under the age of 12 unless directed by physician.

DRUG INTERACTIONS SECTION.

Drug Interactions:. Ribotin-E TM is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel).

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Ribotin-E TM are yellow with slightly brown speckled, coated caplets. Bottles contain 60 caplets NDC 59088-182-58. Dispense in tight, light-resistant container as defined in the USP/NF with child-resistant closure.

INDICATIONS & USAGE SECTION.

INDICATIONS:. Ribotin-E 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 deficiency occur together, along with deficient intake or increased need for B-Complex vitamins in chronic and acute illness, as well as cases of metabolic stress, and in convalescence.

OVERDOSAGE SECTION.

OVERDOSE:. 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. Ribotin-E(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. Treatment:. For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Ribotin-E TM Manufactured in the USA by:PureTek CorporationPanorama City, CA 91402 Questions Call toll-free: 1-877-921-7873 Label.

PRECAUTIONS SECTION.

Precaution Section. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.The patients medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.For use on the order of healthcare practitioner.Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

SPL UNCLASSIFIED SECTION.

Treatment:. For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

WARNINGS SECTION.

WARNING:. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call 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.. Precaution Section. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.There is potential danger in administering folic acid to patients with undiagnosed anemia, since folic acid may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurologic complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurologic changes caused by pernicious anemia.The patients medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.For use on the order of healthcare practitioner.Call your doctor about side effects. To report side effects, call PureTek Corporation at 1-877-921-7873 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. Drug Interactions:. Ribotin-E TM is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, or Clopidogrel). Adverse Reactions:. Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation)occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, giving Ribotin-E(TM) after meals may control occasional gastrointestinal disturbances. Ribotin-E(TM) is best absorbed when taken at bedtime. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usually recommended levels, has been associated with gastrointestinal intolerance in some patients.