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

TL-HEM 150 by

Drug Labeling and Warnings

TL-HEM 150 by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS TABLE

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.

CONTRAINDICATIONS

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.

WARNINGS

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: 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

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.

DESCRIPTION

TL-HEM 150 caplets are oval, beige, film-coated caplets debossed “TL606”.

DIRECTIONS FOR USE

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

HOW SUPPLIED

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

PRODUCT CODE 13811-609-90

STORAGE

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

HEALTH CLAIM

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

PRINCIPAL DISPLAY PANEL

TL-HEM 150

NDC: 13811-609-90

90 Count

Rev072018

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	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-609
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, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	30 [iU]
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1000 ug
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 CATION	3 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	50 mg

Inactive Ingredients
Ingredient Name	Strength
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
POLYVINYL ALCOHOL, UNSPECIFIED (UNII: 532B59J990)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POLYETHYLENE GLYCOLS (UNII: 3WJQ0SDW1A)
TALC (UNII: 7SEV7J4R1U)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
POVIDONE K30 (UNII: U725QWY32X)
ACACIA (UNII: 5C5403N26O)
STEARIC ACID (UNII: 4ELV7Z65AP)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-609-90	90 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		04/01/2018

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	19 mm

Labeler - Trigen Laboratories, LLC (830479668)