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.

Drug Label Information

Updated September 23, 2011

If you are a consumer or patient please visit this version.

  • BOXED WARNING(What is this?)

    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.

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  • SPL UNCLASSIFIED SECTION

    Rx Only

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  • 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.

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  • 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.

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  • CONTRAINDICATIONS

    This product is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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  • 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.

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  • 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.

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  • 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.

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  • DOSAGE AND ADMINISTRATION

    One caplet daily or as prescribed by a physician.

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  • HOW 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].

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  • 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.

    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

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  • PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label

    NDC 13811-606-90

    TL-HEM 150

    Rx Only

    TRIGEN
    LABORATORIES

    90 CAPLETS

    PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
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  • INGREDIENTS AND APPEARANCE
    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 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)
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