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  <title>Trigels-F<br/> Forte</title>
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                <name>Trigels-F Forte</name>
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                    <name>Folic Acid, Ascorbic Acid, Cyanocobalamin, and Ferrous Fumarate</name>
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                    <name>titanium dioxide</name>
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                    <name>FD&amp;C Blue No. 1</name>
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          <title>DESCRIPTION</title>
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            <paragraph>
              <content styleCode="bold">Other Ingredients</content>: Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Soy Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&amp;C Red #40, FD&amp;C Yellow #5, FD&amp;C Blue #1</paragraph>
            <paragraph>
              <br/>
              <content styleCode="bold">THIS PRODUCT CONTAINS SOY.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold"> </content>
              <br/>Trigels-F Forte is a prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.</paragraph>
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          <effectiveTime value="20211124"/>
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              <title>Inactive Ingredients</title>
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                <paragraph>Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Beeswax, Lecithin, Ethyl Vanillin, Titanium Dioxide, FD&amp;C Red #40, FD&amp;C Yellow #5, FD&amp;C Blue #1.</paragraph>
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          <title>CONTRAINDICATIONS</title>
          <text>
            <paragraph>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.</paragraph>
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                    <content styleCode="bold">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.</content>
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          <title>PRECAUTIONS</title>
          <text>
            <paragraph>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.<br/>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Folic Acid: </content>Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B<sub>12</sub> 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.<br/>
            </paragraph>
            <paragraph>The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.<br/>
            </paragraph>
            <paragraph>This product contains FD&amp;C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&amp;C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.<br/>
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          <title>ADVERSE REACTIONS</title>
          <text>
            <paragraph>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.</paragraph>
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          <title>OVERDOSAGE</title>
          <text>
            <paragraph>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.<br/>
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          <title>DESCRIPTION</title>
          <text>
            <paragraph>Trigels-F Forte is a brown, oblong shaped softgel with laser imprinted “TL518” containing dark brown paste.<br/>
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          <title>DIRECTIONS FOR USE</title>
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            <paragraph>Take one softgel capsule by mouth daily or as directed by a physician.</paragraph>
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          <title>HOW SUPPLIED</title>
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            <paragraph>Trigels-F Forte is available in child resistant blister packs of 100 (10 x 10) softgel capsules.</paragraph>
            <paragraph>
              <br/>
              <content styleCode="bold">Product Code: 13811-518-10</content>
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          <title>STORAGE</title>
          <text>
            <paragraph>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. </paragraph>
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            <paragraph>
              <content styleCode="bold">KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">For use on the order of a healthcare practitioner</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <br/>Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-770-509-4500 or FDA at<br/>1-800-FDA-1088 or www.fda.gov/medwatch.</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">
                <br/>PLR-TRIGELSF-00001-1                                                                Rev. 11/2021<br/>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Manufactured for:<br/>Trigen Laboratories, LLC<br/>Alpharetta, GA 30005<br/>www.trigenlab.com</content>
            </paragraph>
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            <paragraph>
              <content styleCode="bold">13811-518-10<br/>
                <br/>
              </content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Trigels-F<br/>Forte</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">Softgels</content>
            </paragraph>
            <paragraph>
              <content styleCode="bold">100 SOFTGELS</content>
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              <content styleCode="bold">TRIGEN<br/>LABORATORIES</content>
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              <text>Trigels F Forte Carton Rev. 11/2021</text>
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