Label: TL-HEM 150- ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, cyanocobalamin, biotin, iron, cupric sulfate, and docusate sodium tablet, film coated
- NDC Code(s): 13811-606-90
- Packager: TRIGEN Laboratories, Inc.
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
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.
Updated September 23, 2011
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- BOXED WARNING(What is this?)
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.Close
- SPL UNCLASSIFIED SECTION
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
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
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.Close
This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.Close
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.Close
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.
Safety and effectiveness in pediatric patients with this product have not been established.
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.Close
- DOSAGE AND ADMINISTRATION
One caplet daily or as prescribed by a physician.Close
- HOW SUPPLIED
TL-HEM 150 is supplied in bottles of 90 caplets.
- SPL UNCLASSIFIED SECTION
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.
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.
TRIGEN Laboratories, Inc.
Sayreville, NJ 08872
- PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
- INGREDIENTS AND APPEARANCE
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 Item Code (Source) NDC:13811-606 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid 500 mg .Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.Alpha.-Tocopherol Acetate, DL- - UNII:WR1WPI7EW8) .Alpha.-Tocopherol Acetate, DL- 30 [iU] Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid 1 mg Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin 60 ug Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin 150 ug Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron 150 mg Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Sulfate 3 mg Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium 50 mg Inactive Ingredients Ingredient Name Strength Cellulose, Microcrystalline (UNII: OP1R32D61U) Polyvinyl Alcohol (UNII: 532B59J990) Potassium Citrate Anhydrous (UNII: 86R1NVR0HW) Citric Acid Monohydrate (UNII: 2968PHW8QP) Titanium Dioxide (UNII: 15FIX9V2JP) Povidone (UNII: FZ989GH94E) Acacia (UNII: 5C5403N26O) Stearic Acid (UNII: 4ELV7Z65AP) Silicon Dioxide (UNII: ETJ7Z6XBU4) Magnesium Stearate (UNII: 70097M6I30) Talc (UNII: 7SEV7J4R1U) Polyethylene Glycols (UNII: 3WJQ0SDW1A) FD&C Yellow No. 6 (UNII: H77VEI93A8) FD&C Blue No. 2 (UNII: L06K8R7DQK) Product Characteristics Color BROWN (beige) Score no score Shape OVAL (caplet) Size 19mm Flavor Imprint Code TL606 Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:13811-606-90 90 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)