Trigels-F Forte (folic acid 1 mg ascorbic acid 60 mg cyanocobalamin 10 ug ferrous fumarate 151 mg) Dailymed
Generic: folic acid, ascorbic acid, cyanocobalamin, and ferrous fumarate is used for the treatment of Anemia, Pernicious Diabetic Neuropathies Multiple Sclerosis Vitamin B 12 Deficiency Alcoholic Neuropathy Common Cold Hyperoxaluria Methemoglobinemia Scurvy Wounds, Penetrating Tyrosinemias Anemia, Hemolytic Anemia, Megaloblastic Hemochromatosis Hemosiderosis Pregnancy Complications, Hematologic Anemia, Iron-Deficiency Anemia, Aplastic Folic Acid Deficiency Neural Tube Defects
IMPRINT: TL518
SHAPE: oval
COLOR: brown
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Description
Other Ingredients: Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Soy Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1
THIS PRODUCT CONTAINS SOY.
Trigels-F Forte is a prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.
Inactive Ingredients
Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&C Red #40, FD&C Yellow #5, FD&C Blue #1.
Contraindications
Trigels-F Forte should not be used by patients with a known hypersensitivity to any of the uled ingredients including soy. All iron compounds are contraindicated in patients with hemochromatosis, hemosiderosis, or hemolytic anemias.
Warnings Section
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.
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. 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.
Description
Trigels-F Forte is a brown, oblong shaped softgel with laser imprinted “TL518” containing dark brown paste.
Directions For Use
Take one softgel capsule by mouth daily or as directed by a physician.
How Supplied
Trigels-F Forte is available in child resistant buler packs of 100 (10 x 10) softgel capsules.
Product Code: 13811-518-10
Storage
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat.
Health Claim Section
KEEP THIS PRODUCT 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, LLC at 1-770-509-4500 or FDA at1-800-FDA-1088 or www.fda.gov/medwatch.
PLR-TRIGELSF-00001-1 Rev. 11/2021
Manufactured for:Trigen Laboratories, LLCAlpharetta, GA 30005www.trigenlab.com
Principal Display Panel - 100 Softgel Blister Pack Carton
13811-518-10
Trigels-FForte
Softgels
100 SOFTGELS
TRIGENLABORATORIES
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