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Chromagen Forte Soft Gelatin Capsules (Ther-Rx)
P4817 12/04
DESCRIPTION
Each soft gelatin capsule for oral administration contains:
Iron
Ferrochel® * (elemental iron) ................................ 70 mg
Ferrous fumerate (elemental iron) .......................... 81 mg
Vitamin C as Ester-C® †
Ascorbic acid (as calcium ascorbate) .................... 60 mg
Threonic acid (as calcium threonate) .................... 0.8 mg
Folic Acid, USP ...................................................... 1 mg
Vitamin B 12 (cyanocobalamin) .............................. 10 mcg
* Ferrochel® (ferrous bis-glycinate chelate) is a registered trademark of Albion International, Inc., Clearfield, Utah, and is protected under U.S. Patent Nos. 4,599,152 and 4,830,716.
† Ester-C® is a patented pharmaceutical grade material consisting of calcium ascorbate and calcium threonate. Ester-C® is a licensed trademark of Zila Nutraceuticals, Inc.
Inactive Ingredients: Soybean oil, gelatin, glycerine, lecithin (unbleached), yellow beeswax, titanium dioxide, methyl paraben, ethyl vanillin, FD& Yellow No. 6, FD&Red No. 40, propyl paraben, FD& Blue No. 1.
INDICATIONS AND USAGE
For the treatment of all anemias responsive to oral iron therapy, such as hypochromic anemia associated with pregnancy, chronic or acute blood loss, dietary restriction, metabolic disease and post-surgical convalescence.
CONTRAINDICATIONS
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 is deficient.
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. Allergy Alert: These gelatin capsules contain a soy product.
PRECAUTIONS
General
Do not exceed recommended dose.
Folic Acid
Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive. Pernicious anemia should be excluded before using this product since folic acid may mask the symptoms of pernicious anemia.
Pediatric Use
Safety and effectiveness in pediatric patients have not been established.
Geriatric Use
Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for an elderly patient should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function, and of concomitant disease or other drug therapy.
ADVERSE REACTIONS
Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
Usual adult dose is 1 to 2 soft gelatin capsules daily, or as directed by a physician.
HOW SUPPLIED
Chromagen® Forte Capsules are brown soft gelatin capsules imprinted with "THX 0131" in grey ink in child- resistant, unit-dose packages of 100 capsules (10 x 10 Unit Dose Packs) (NDC 64011-131-11).
Store at controlled room temperature 25°C (77°F); excursions permitted to 15°- 30°C (59°- 86°F). [See USP Controlled Room Temperature.] Avoid excessive heat 40°C (104°F). Avoid freezing.
Mktd. by Ther-Rx Corp.
St. Louis, MO 63044
U.S. Patent Nos. 4,599,152; 4,822,816; 4,830,716; 5,070,085.
P4817 12/04
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