Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium
FDA Drug Information • Also known as: Ferralet 90
- Brand Names
- Ferralet 90
- Drug Class
- Vitamin C [EPC], Vitamin B12 [EPC]
- Route
- ORAL
- Dosage Form
- TABLET, FILM COATED
- Product Type
- HUMAN PRESCRIPTION DRUG
⚠ Boxed Warning (Black Box)
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.
Description
DESCRIPTION Each green film-coated tablet for oral administration contains: Iron (Carbonyl iron, ferrous gluconate) 90 mg Folic Acid 1 1 mg Vitamin B 12 (Cyanocobalamin) 12 mcg Vitamin C (Ascorbic acid) 120 mg Docusate sodium 50 50 mg Inactive Ingredients: Povidone, croscarmellose sodium, acrylic resin, color added, magnesium stearate, FD&C Yellow No. 5, magnesium silicate, FD&C Blue No. 1, polyethylene glycol, vitamin A palmitate, ethyl vanillin.
What Is Iron, Folic Acid, Cyanocobalamin, Ascorbic Acid, And Docusate Sodium Used For?
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.
Side Effects (Adverse Reactions)
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.
Warnings and Precautions
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.
Overdosage
OVERDOSAGE Symptoms: abdominal pain, metabolic acidosis, anuria, CNS damage, coma, convulsions, death, dehydration, diffuse vascular congestion, hepatic cirrohosis, hypotension, hypothermia, lethargy, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, tachycardia, hyperglycemia, drowsiness, pallor, cyanosis, lassitude, seizures, and shock.
How Supplied
HOW SUPPLIED Ferralet ® 90 (NDC 0178-0089-90) is a green, modified rectangle shaped, film-coated tablet, debossed with "F6" on one side and blank on the other, and packaged in bottles of 90. Store at 25°C (77°F). Excursions permitted to 15°-30°C (59°-86°F). (See USP Controlled Room Temperature.)
About This Information
This drug information is sourced from FDA-approved labeling via the openFDA database. It is intended for educational and reference purposes only. This is not medical advice. Always consult your healthcare provider before making decisions about medication. Drug information may be updated by the FDA; check with your pharmacist for the most current information.
What are side effects?
Side effects are unwanted reactions that can occur when taking a medication. They range from mild (headache, nausea) to severe (allergic reactions, organ damage). Not everyone experiences side effects, and severity varies. Report any concerning side effects to your doctor.
What are drug interactions?
Drug interactions occur when a medication is affected by another drug, food, or supplement. Interactions can make medications less effective or cause dangerous side effects. Always tell your doctor about all medications and supplements you take.