Trigelsd-F Forte

Precautions re: Allergies

This product contains soy.

Formulation re: Other

Trigels-F Forte is a prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

Precautions re: All Other

Contraindications Trigels-F Forte should not be used by patients with a known hypersensitivity to any of the listed ingredients including soy. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.

Precautions re: Children

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 re: All Other

Precautions Do not exceed recommended dose. The type of anemia and the underlying cause or causes should be determined before starting therapy with Trigels-F Forte. 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.

Precautions re: All Other

Folic Acid: 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 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurologic manifestations remain progressive.

Precautions re: Pregnant or Nursing or Prescription Medications

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

Formula re: Contains

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

Precautions re: Allergies

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Adverse Reactions Allergic sensitization has been reported following both oral and parenteral administration of folic acid, as well as possibly the use of other forms of folates, including reduced folates. Mild transient diarrhea, polycythemia vera, itching, transitory exanthema and the feeling of swelling of the entire body have been associated with cyanocobalamin.

Precautions re: All Other

Over dosage The clinical course 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.

Formulation re: Other

Description Trigels-F Forte is a brown, oblong shaped softgel with laser imprinted “TL518” containing dark brown paste.

Suggested/Recommended/Usage/Directions

Directions for Use Take one softgel capsule by mouth daily or as directed by a physician.

General Statements: All Other Content

How Supplied Trigels-F Forte is available in child resistant blister packs of 100 (10 x 10) softgel capsules.

Storage

Storage Store at 20 degrees -25 degrees C (68 degrees -77 degrees F), excursions permitted to 15 degrees -30 degrees C (59 degrees -86 degrees F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat.

Precautions re: Children

Keep this product out of reach of children.

General Statements: All Other Content

For use on the order of a healthcare practitioner

Precautions re: All Other

Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-888-9-TRIGEN (1-888-987-4436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

General Statements: All Other Content

Customer Service: 1-888-987-4436