TL-HEM 150 caplets are oval, beige, film-coated caplets debossed "TL606" .
| Each caplet for oral administration contains: | |
| Vitamin C (ascorbic acid) | 500 mg |
| Vitamin E (dl-alpha tocopheryl acetate) | 30 IU |
| Folic Acid | 1 mg |
| Vitamin B12 (cyanocobalamin) | 60 mcg |
| Biotin | 150 mcg |
| Iron (carbonyl iron) | 150 mg |
| Copper (cupric sulfate) | 3 mg |
| Docusate Sodium | 50 mg |
Inactive Ingredients
Microcrystalline Cellulose, Polyvinyl Alcohol, TriPotassium Citrate, Citric Acid, Titanium Dioxide, Povidone, Acacia, Stearic Acid, Fumed Silica, Magnesium Stearate, Talc, Polyethylene Glycol, FD&C Yellow #6, FD&C Blue #2.
Indications and Usage for TL-HEM 150
TL-HEM 150 is indicated in the treatment of most megaloblastic, macrocytic and iron-deficiency anemias, in the anemias of pregnancy, in those anemias occurring in a variety of malabsorption syndromes, and those of nutritional origin. It is a useful adjuvant in patients in whom erythropoiesis is suppressed due to severe infections, malignancies or to the toxic effects of certain chemotherapeutic agents. A deficiency of Vitamin E may increase the fragility of red blood cells, with resultants enhanced hemolysis.
TL-HEM 150 is a hematinic preparation containing multiple ingredients essential to normal erythropoiesis, plus a stool softener to counteract the possible constipating effects of iron. Vitamin C is present to aid the absorption of iron.
Contraindications
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
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.
Precautions
General
Do not exceed recommended dose.
Some patients affected with pernicious anemia may not respond to orally administered Vitamin B12 with intrinsic factor concentrate and there is no known way to predict which patients will respond or which patients may cease to respond. Periodic examinations, laboratory studies of pernicious anemia patients are essential and recommended. If any symptoms of intolerance occur, the drug should be temporarily or permanently discontinued, which should be determined by a physician.
Pediatric Use
Safety and effectiveness in pediatric patients with this product have not been established.
Geriatric Use
Sufficient 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 functions, and of concomitant disease or other drug therapy.
Adverse Reactions
Adverse reactions with iron therapy may include gastrointestinal intolerance, diarrhea, nausea, vomiting, dark stools and abdominal pain. Skin rashes of various types may occur. Such reactions may necessitate temporary or permanent changes in dosage or usage. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
TL-HEM 150 Dosage and Administration
One caplet daily or as prescribed by a physician.
How is TL-HEM 150 Supplied
TL-HEM 150 is supplied in bottles of 90 caplets.
NDC 13811-606-90
STORAGE
Store at Controlled Room Temperature 15°-30° C (59°- 86°F). [See USP].
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.
Rx Only
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.
Manufactured for:
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
www.trigenlab.com
Rev. 01/11
PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
NDC 13811-606-90
TL-HEM 150
Rx Only
TRIGEN
LABORATORIES
90 CAPLETS
| TL-HEM 150 ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, cyanocobalamin, biotin, iron, cupric sulfate, and docusate sodium tablet, film coated | ||||||||||||||||||||||||||||||||
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| Marketing Information | |||
| Marketing Category | Application Number or Monograph Citation | Marketing Start Date | Marketing End Date |
| Unapproved drug other | 01/01/2011 | ||
| Labeler - TRIGEN Laboratories, Inc. (830479668) |
