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Ferralet 90

RxNorm 836268· IRON, FOLIC ACID, CYANOCOBALAMIN, ASCORBIC ACID, AND DOCUSATE SODIUM· ORAL

Vitamin C [EPC], Vitamin B12 [EPC] · Mission Pharmacal Company

Boxed Warning

WARNING Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

Indications and usage

INDICATIONS AND USAGE Ferralet ® 90 is indicated for the treatment of all anemias that are responsive to oral iron therapy. These include: hypochromic anemia associated with pregnancy, chronic and/or acute blood loss, metabolic disease, postsurgical convalescence, and dietary needs.

Dosage and administration

DOSAGE AND ADMINISTRATION One tablet daily or as directed by a physician.

Warnings

WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.

Contraindications

CONTRAINDICATIONS Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.

Adverse events

Most frequently reported events (FDA FAERS). Report frequency does not imply causation.

  • asthenia3
  • fatigue3
  • muscle spasms3
  • abdominal pain upper2
  • depression2
  • flushing2
  • gastrooesophageal reflux disease2
  • hepatic enzyme increased2
  • oedema peripheral2
  • product quality issue2
  • pruritus2
  • abdominal discomfort1
  • autoimmune hepatitis1
  • back pain1
  • blood albumin decreased1
  • blood cholesterol increased1

Adverse reactions (label)

ADVERSE REACTIONS Adverse reactions with iron therapy may include GI irritation, constipation, diarrhea, nausea, vomiting, and dark stools. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

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