Chromagen Soft Gelatin Capsules (Ther-Rx), Drug Reference Encyclopedia




Chromagen Soft Gelatin Capsules (Ther-Rx)

Description

Indications and Usage

Dosage and Administration

How Supplied

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P4809 12/04

DESCRIPTION

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.

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

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.

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.

DOSAGE AND ADMINISTRATION

Usual adult dose is 1 soft gelatin capsule daily, or as directed by a physician.

HOW SUPPLIED

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.

P4809 12/04

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