TL-HEM 150

Other Ingredients: Microcrystalline Cellulose, Coating (Polyvinyl Alcohol, Titanium Dioxide, Polyethylene Glycol, Talc, FD&C Yellow #6 Lake, FD&C Blue #2 Lake), Tripotassium Citrate, Citric Acid, Povidone K30, Acacia, Stearic Acid, Fumed Silica, and Magnesium Stearate.

TL-HEM 150 is a hematinic multivitamin/multimineral dietary supplement used to improve the nutritional status of patients with iron deficiency.

This product is contraindicated in patients with a known hypersensitivity to any of the components of this product. Hemochromatosis and hemosiderosis are contraindications to iron therapy.

General: 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. Do not exceed recommended daily 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. Periodic clinical assessment of pernicious anemia patients by a physician are recommended. If any symptoms of intolerance to TL-HEM 150, including but not limited to nausea, vomiting, abdominal cramps or rash occur, the drug should be discontinued, as determined by a physician.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone test, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Safety and effectiveness in elderly patients have not been established.

Adverse reactions with iron therapy may include constipation, 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 caplets are oval, beige, film-coated caplets debossed “TL606”.

Usual adult dose is one caplet daily or as prescribed by a physician.

TL-HEM 150 is supplied in bottles of 90 caplets.

PRODUCT CODE 13811-609-90

Store at 20°-25°C (68°-77°F), excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

KEEP OUT OF REACH OF CHILDREN.

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Customer Service: 1-888-987-4436                             Rev. 07/2018

Manufactured for:

Trigen Laboratories, LLC

Bridgewater, NJ 08807

TRIGEN LOGO

TL-HEM 150

NDC 13811-609-90

90 Count

Rev072018