TL-HEM 150 by TRIGEN Laboratories, Inc. TL-HEM 150 Caplets

TL-HEM 150 by

Drug Labeling and Warnings

TL-HEM 150 by is a Prescription medication manufactured, distributed, or labeled by TRIGEN Laboratories, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

TL-HEM 150- ascorbic acid, .alpha.-tocopherol acetate, dl-, folic acid, cyanocobalamin, biotin, iron, cupric sulfate, and docusate sodium tablet, film coated 
Trigen Laboratories, LLC

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.

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TL-HEM 150
Caplets

Rx Only

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 Acid1 mg
Vitamin B12 (cyanocobalamin)60 mcg
Biotin150 mcg
Iron (carbonyl iron)150 mg
Copper (cupric sulfate)3 mg
Docusate Sodium50 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

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.

DOSAGE AND ADMINISTRATION

One caplet daily or as prescribed by a physician.

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].

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

PRINCIPAL DISPLAY PANEL - 90 Caplet Bottle Label
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 TypeHUMAN PRESCRIPTION DRUGItem Code (Source)NDC: 13811-606
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R) Ascorbic Acid500 mg
.Alpha.-Tocopherol Acetate, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01) .ALPHA.-TOCOPHEROL, DL-30 [iU]
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8) Folic Acid1 mg
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204) Cyanocobalamin60 ug
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04) Biotin150 ug
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7) Iron150 mg
Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L) Cupric Cation3 mg
Docusate Sodium (UNII: F05Q2T2JA0) (Docusate - UNII:M7P27195AG) Docusate Sodium50 mg
Inactive Ingredients
Ingredient NameStrength
Cellulose, Microcrystalline (UNII: OP1R32D61U)  
POLYVINYL ALCOHOL, UNSPECIFIED (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 GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)  
FD&C Yellow No. 6 (UNII: H77VEI93A8)  
FD&C Blue No. 2 (UNII: L06K8R7DQK)  
Product Characteristics
ColorBROWN (beige) Scoreno score
ShapeOVAL (caplet) Size19mm
FlavorImprint Code TL606
Contains    
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NDC: 13811-606-9090 in 1 BOTTLE; Type 0: Not a Combination Product01/01/201108/31/2019
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
UNAPPROVED DRUG OTHER01/01/201108/31/2019
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 11/2019
 
Trigen Laboratories, LLC