Trigelsd-F Forte

Product Overview

Brand: Trigen Laboratories

Barcode: 3 13811 51810 8

Net Contents: 100 Softgel(s)

Serving Size (Overview): 1 Softgel Capsule(s)

Product Type: Other Combinations [A1325]

Form: Softgel Capsule [E0161]

Date Entered: Dec 18, 2021

Market Status: On Market

Suggested Use (Overview): Directions for UseTake one softgel capsule by mouth daily or as directed by a physician.

Product Self-Roles:

No specific self-roles defined.

Dietary Supplement Facts

Ingredient	Category	Amount Per Serving	Unit	% Daily Value	Target Group	Serving Size (Fact)
Calories	other	10	Calorie(s)	N/A	N/A	1 Softgel Capsule(s)
Total Fat	fat	0.5	Gram(s)	<1	Adults and children 4 or more years of age	1 Softgel Capsule(s)
Total Carbohydrates	sugar	<1	Gram(s)	<1	Adults and children 4 or more years of age	1 Softgel Capsule(s)
Vitamin C	vitamin	60	mg	67	Adults and children 4 or more years of age	1 Softgel Capsule(s)
Folate	vitamin	1667	mcg DFE	417	Adults and children 4 or more years of age	1 Softgel Capsule(s)
Folic Acid	vitamin	1000	mcg	N/A	N/A	1 Softgel Capsule(s)
Vitamin B12	vitamin	10	mcg	417	Adults and children 4 or more years of age	1 Softgel Capsule(s)
Iron	mineral	151	mg	839	Adults and children 4 or more years of age	1 Softgel Capsule(s)

Other Ingredients

Soybean Oil; Gelatin; Water; Purified; yellow Beeswax; Soy Lecithin; Ethyl Vanillin; Titanium Dioxide; FD&C Red #40; FD&C Yellow #5; FD&C Blue #1

Label Statements

Precautions

This product contains soy. ContraindicationsTrigels-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. PrecautionsDo 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. 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. 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.Adverse ReactionsAllergic 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. Over dosageThe 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 at1-800-FDA-1088 or www.fda.gov/medwatch.

Formulation

Trigels-F Forte is a prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. 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. DescriptionTrigels-F Forte is a brown oblong shaped softgel with laser imprinted “TL518” containing dark brown paste.

Suggested Use

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

Other

How SuppliedTrigels-F Forte is available in child resistant blister packs of 100 (10 x 10) softgel capsules. For use on the order of a healthcare practitioner Customer Service: 1-888-987-4436

Product Specific Information

StorageStore 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.