Trigels-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; Glycerin; 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. 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 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. OverdosageThe 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. 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. DescriptionTrigels-F Forte is a brown oblong shaped softgel with laser imprinted “TL518” containing dark brown paste.
Statement of Identity
- Dietary Supplement
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
- 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.
Associated Company Information & Roles
Trigen Laboratories LLC
Alpharetta,
GA
30005
Roles for this Product:
- Distributor