TARON FORTE- iron, calcium ascorbate, cyanocobalamin, and folic acid capsule

Taron Forte by

Drug Labeling and Warnings

Taron Forte by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

Taron Forte Multivitamin/Mineral with Iron capsules are indicated for the distinctive nutritional requirements of persons being treated for iron deficiencies by a physician.

CONTRAINDICATIONS

Taron Forte Capsules are 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: The type of anemia and the underlying cause or causes should be determined before starting therapy with Taron Forte Capsules. Since the anemia may be a result of a systemic disturbance, such as recurrent blood loss, the underlying cause or causes should be corrected, if possible.

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient.
Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use: Safety and effectiveness of this product have not been established in pediatric patients.

ADVERSE REACTIONS

Adverse reactions with iron therapy may include constipation, diarrhea, nausea, vomiting, dark stools, and abdominal pain. Adverse reactions with iron therapy are usually transient. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

The clinical cause of acute iron overdosage can be variable. Initial symptoms may include: abdominal pain, nausea, vomiting, diarrhea, tarry stools, melena, hematemesis, hypotension, tachycardia, metabolic acidosis, hyperglycemia, dehydration, drowsiness, pallor, cyanosis, lassitude, seizures, shock, and coma.

DESCRIPTION

Taron Forte Capsules are orange, imprinted with “TL042”. 

DIRECTIONS FOR USE

One (1) capsule daily or as directed by a physician. 

HOW SUPPLIED

Taron Forte Capsules are packaged in child-resistant bottles of 100 capsules.

PRODUCT CODE 13811-042-10.

STORAGE

Store at 20°-25°C (68°-77°F), excursion permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from light and moisture.  Dispense in a tight, light-resistant container with a child-resistant closure as defined in the USP/NF.

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 - 100 Capsule Bottle Label

13811-042-10

100 Capsules

Taron Forte
CAPSULES

TRIGEN
LABORATORIES

INGREDIENTS AND APPEARANCE

TARON FORTE 
iron, calcium ascorbate, cyanocobalamin, and folic acid capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-042
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	150 mg
CALCIUM ASCORBATE (UNII: 183E4W213W) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	60 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	25 ug
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg

Inactive Ingredients
Ingredient Name	Strength
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
GELATIN (UNII: 2G86QN327L)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
FD&C RED NO. 3 (UNII: PN2ZH5LOQY)
MAGNESIUM STEARATE (UNII: 70097M6I30)
PROPYLENE GLYCOL (UNII: 6DC9Q167V3)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C RED NO. 40 (UNII: WZB9127XOA)
SHELLAC (UNII: 46N107B71O)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-042-10	100 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		05/01/2009

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	22 mm

Labeler - Trigen Laboratories, LLC (830479668)