TL-HEM 150

Generic Name: ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, cyanocobalamin, biotin, iron, cupric sulfate and docusate sodium
Dosage Form: tablet, film coated

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

TL-HEM 150
Caplets

Rx Only

TL-HEM 150 Description

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.

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.

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
Product Information
Product Type HUMAN PRESCRIPTION DRUG LABEL Item Code (Source) NDC:13811-606
Route of Administration ORAL DEA Schedule     
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 500 mg
.Alpha.-Tocopherol Acetate, DL- (.Alpha.-Tocopherol Acetate, DL-) .Alpha.-Tocopherol Acetate, DL- 30 [iU]
Folic Acid (Folic Acid) Folic Acid 1 mg
Cyanocobalamin (Cyanocobalamin) Cyanocobalamin 60 ug
Biotin (Biotin) Biotin 150 ug
Iron (Iron) Iron 150 mg
Cupric Sulfate (Cupric Cation) Cupric Sulfate 3 mg
Docusate Sodium (Docusate) Docusate Sodium 50 mg
Inactive Ingredients
Ingredient Name Strength
Cellulose, Microcrystalline  
Polyvinyl Alcohol  
Potassium Citrate Anhydrous  
Citric Acid Monohydrate  
Titanium Dioxide  
Povidone  
Acacia  
Stearic Acid  
Silicon Dioxide  
Magnesium Stearate  
Talc  
Polyethylene Glycols  
FD&C Yellow No. 6  
FD&C Blue No. 2  
Product Characteristics
Color BROWN (beige) Score no score
Shape OVAL (caplet) Size 19mm
Flavor Imprint Code TL606
Contains         
Packaging
# Item Code Package Description
1 NDC:13811-606-90 90 TABLET, FILM COATED (TABLET) in 1 BOTTLE
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)
Revised: 09/2011
 
TRIGEN Laboratories, Inc.
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