FDA records indicate that there are no current recalls for this drug.
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Side Effects & Adverse Reactions
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 poison control center immediately. |
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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 Folivane™-OB after meals may control occasional G.I. disturbances. Folivane™-OB is best absorbed when taken at bedtime.
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. Folivane™-OB should be stored beyond the reach of children to prevent against accidental iron poisoning.
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.
KEEP OUT OF THE REACH OF CHILDREN.
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Uses
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History
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Sources
Folivane-ob Manufacturers
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Trigen Laboratories, Inc.
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