Drug Facts
Composition & Profile
Identifiers & Packaging
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.); PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Label NDC 0178-0089-90 Rx Only Ferralet ® 90 90 mg Dual-Iron Delivery 90 Coated Tablets MISSION ® PHARMACAL Label
- 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.)
- PRINCIPAL DISPLAY PANEL - 90 mg Tablet Bottle Label NDC 0178-0089-90 Rx Only Ferralet ® 90 90 mg Dual-Iron Delivery 90 Coated Tablets MISSION ® PHARMACAL Label
Overview
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.
Indications & 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 & Administration
One tablet daily or as directed by a physician.
Warnings & Precautions
WARNING Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B 12 is deficient.
Boxed 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.
Contraindications
Hypersensitivity to any of the ingredients. Hemolytic anemia, hemochromatosis, and hemosiderosis are contraindications to iron therapy.
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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