Trigels-F Forte by Trigen Laboratories

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Supplement Facts

Serving Size: 1 Softgel Capsule(s), 1 time daily

Servings Per Container: 100

Amount Per Serving % Daily Value* (Adults and children 4 or more years of age)

Calories 10 Calorie(s)

Total Fat 0.50 Gram(s) 1%

Carbohydrate 1 Gram(s) 1%

Vitamin C (Ascorbic Acid) 60 mg 67%

Folate 1,667 mcg DFE 417%

Folate 1,000 mcg

Vitamin B12 (Cyanocobalamin) 10 mcg 417%

Iron (Ferrous Fumarate) 151 mg 839%

* Percent Daily Values (DV) are based on a 2,000 calorie diet. † Daily Value not established.

Other Ingredients: Soybean Oil, Gelatin, Glycerin, Water, Purified, yellow Beeswax, Soy Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1.

Statements

Suggested Use:

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

Warnings:

This product contains soy.

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.

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
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.

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

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.

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.

Overdosage
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.

Keep this product out of reach of children.

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.

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.

Other Information:

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

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

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