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Chromagen Soft Gelatin Capsules (Ther-Rx)
- Drugs index
Each soft gelatin capsule for oral administration contains:
Iron (as Ferrochel® * elemental iron) 70 mg
Vitamin C as Ester-C® **/*
Ascorbic acid (as calcium ascorbate)150 mg
Threonic acid (as calcium threonate) 2 mg
Vitamin B 12 (cyanocobalamin) 10 mcg
Desiccated stomach substance100 mg
* 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, yellow beeswax, lecithin (unbleached), titanium dioxide, methyl/propyl paraben blend, ethyl vanillin, FD&C Red No. 40, FD&C Yellow No. 6, FD&C 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.
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindications to iron therapy.
Allergy Alert: These gelatin capsules contain a soy product.
Do not exceed recommended dose.
Safety and effectiveness in pediatric patients have not been established.
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 with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools and abdominal pain. Adverse reactions with iron therapy are usually transient.
DOSAGE AND ADMINISTRATION
Usual adult dose is 1 soft gelatin capsule daily, or as directed by a physician.
Chromagen® Capsules are red soft gelatin capsules imprinted with "THX 0129" in grey ink in child-resistant, unit-dose packages of 100 capsules (10 × 10 Unit Dose Packs) (NDC 64011-129-11).
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.