ADVERSE REACTIONS SECTION.

Adverse Reactions:. Allergic sensitization and other hypersensitivity reactions have been reported with oral folate supplementation. Ferrous Fumarate: Gastrointestinal disturbances, including anorexia, nausea, diarrhea, and constipation, have been reported. These effects are generally mild and may resolve with continued use. Administration of Boostervite(TM) with food may reduce the occurrence of gastrointestinal disturbances, although iron absorption may be decreased when taken with meals. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients. Call your healthcare provider for medical advice about side effects. You may report side effects to PureTek Corporation at 1-877-921-7873. You may also report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

CLINICAL PHARMACOLOGY SECTION.

CLINICAL PHARMACOLOGY:. Vitamins and minerals are absorbed and metabolized through normal biological pathways, contributing to various physiological functions. The botanical extracts provide additional support for energy levels and overall well-being.

CONTRAINDICATIONS SECTION.

CONTRAINDICATIONS:. This product is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias.

DESCRIPTION SECTION.

DESCRIPTION:. Each Tablet Contains:Vitamin (as ascorbic acid)..................................... 100 mg Vitamin D3 (as cholecalciferol)....................... 10 mcg (400 IU) Thiamin (as thiamine mononitrate)............................... 10 mg Riboflavin .................................................................. 10 mg Niacin (as niacinamide)..............................................10 mg Vitamin B6 (as pyridoxine hydrochloride).......................10 mg Folate (as L-5-Methyltetrahydrofolate calcium salt)........... 1700 mcg DFE (1000 mcg L-5-Methylfolate) Vitamin B12 (as methylcobalamin)............................. 100 mcg Biotin (as d-Biotin)..................................................... 300 mcg Pantothenic Acid (as d-Calcium Pantothenate)................ 50 mg Iron (as Ferrous Fumarate).......................................... 18 mg Withania somnifera (Ashwagandha) Root Powder............ 60 mg Brassica oleracea acephala (Kale) Powder.................... 2.5 mg Brassica oleracea italica (Broccoli) Sprout Powder........... 2.5 mg Citrus sinensis (Orange) Juice Powder............................. 2.5 mg Prunus cerasus (Tart Cherry) Extract................................. 2.5 mg Other Ingredients:Croscarmellose Sodium, Dicalcium Phosphate, Magnesium Stearate (vegetable source), Microcrystalline Cellulose, Silicon Dioxide, Stearic Acid (vegetable source), Coating (Hydroxypropyl Methylcellulose, Polyethylene Glycol 400, Organic Maltodextrin, Organic Sunflower Lecithin, Organic Sunflower Oil, Organic Guar Gum).

DOSAGE & ADMINISTRATION SECTION.

DOSAGE AND ADMINISTRATION:. Take one (1) tablet daily with food, or as directed by healthcare provider. Dosage may be adjusted based on individual patient requirements and clinical response. Do not exceed the recommended dose.

DRUG INTERACTIONS SECTION.

Drug Interactions:. Boostervite(TM) is not recommended for use in patients receiving levodopa, as pyridoxine may antagonize the effects of levodopa. Pyridoxine may antagonize levodopa effects. It may also increase bleeding risk with anticoagulants (e.g., heparin, warfarin) or antiplatelet agents (e.g., aspirin, clopidogrel).

HOW SUPPLIED SECTION.

HOW SUPPLIED:. Boostervite(TM) tablets are yellow to brown, speckled, film-coated tablets, supplied in bottles of 30 tablets (NDC 59088-022-54). Dispense in tight, light-resistant container as defined in the USP/NF, with child-resistant closure. Store at 20 to 25C (68 to 77F) [see USP Controlled Room Temperature]. Protect from light and moisture.

INDICATIONS & USAGE SECTION.

INDICATIONS AND USAGE:. Boostervite(TM) contains combination of vitamins, minerals, and botanical extracts intended to supplement nutritional intake in patients with low energy associated with nutritional needs, under the supervision of healthcare provider.

OVERDOSAGE SECTION.

OVERDOSE:. Signs and symptoms: Iron is toxic in excessive amounts. Acute ingestion of iron may cause nausea, vomiting, abdominal pain, and in severe cases, gastrointestinal bleeding, shock, cardiovascular collapse, and death. Other symptoms may include pallor, cyanosis, melena (black tarry stools), drowsiness, and coma. Severe reactions, including fatalities, have occurred in children from accidental overdose. The estimated toxic dose of orally ingested elemental iron is approximately 300 mg/kg body weight.. Treatment:. For management of iron overdosage, initiate appropriate supportive and symptomatic therapy. Gastric lavage may be performed using sodium bicarbonate solution or milk. Intravenous fluids and electrolyte replacement should be administered as indicated. Oxygen therapy may be required. In cases of severe toxicity, chelation therapy with appropriate agents (e.g., deferoxamine) should be considered. Exchange transfusion may be indicated in life-threatening situations. Management should be guided by healthcare provider based on clinical status and laboratory parameters.

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.

Boostervite(TM). Manufactured in the USA by: PureTek Corporation Panorama City, CA 91402 label.

PRECAUTIONS SECTION.

PRECAUTIONS:. Folate in doses above 0.1 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive. There is potential danger in administering folate to patients with undiagnosed anemia, since folate may obscure the diagnosis of pernicious anemia by alleviating the hematologic manifestations of the disease while allowing the neurological complications to progress. This may result in severe nervous system damage before the correct diagnosis is made. Adequate doses of vitamin B12 may prevent, halt, or improve the neurological changes caused by pernicious anemia. The patients medical conditions and consumption of other drugs, herbs, and/or supplements should be considered. Use with caution in patients receiving sedatives, antihypertensive agents, antidiabetic medications, thyroid hormone therapy, or immunosuppressive therapy, as ashwagandha may potentiate pharmacologic effects. To be used only under the supervision of healthcare provider.. Drug Interactions:. Boostervite(TM) is not recommended for use in patients receiving levodopa, as pyridoxine may antagonize the effects of levodopa. Pyridoxine may antagonize levodopa effects. It may also increase bleeding risk with anticoagulants (e.g., heparin, warfarin) or antiplatelet agents (e.g., aspirin, clopidogrel). Adverse Reactions:. Allergic sensitization and other hypersensitivity reactions have been reported with oral folate supplementation. Ferrous Fumarate: Gastrointestinal disturbances, including anorexia, nausea, diarrhea, and constipation, have been reported. These effects are generally mild and may resolve with continued use. Administration of Boostervite(TM) with food may reduce the occurrence of gastrointestinal disturbances, although iron absorption may be decreased when taken with meals. Adverse reactions have been reported with specific vitamins and minerals but generally at levels substantially higher than those contained herein. However, allergic and idiosyncratic reactions are possible at lower levels. Iron, even at the usual recommended levels, has been associated with gastrointestinal intolerance in some patients. Call your healthcare provider for medical advice about side effects. You may report side effects to PureTek Corporation at 1-877-921-7873. You may also report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

SPL UNCLASSIFIED SECTION.

Treatment:. For management of iron overdosage, initiate appropriate supportive and symptomatic therapy. Gastric lavage may be performed using sodium bicarbonate solution or milk. Intravenous fluids and electrolyte replacement should be administered as indicated. Oxygen therapy may be required. In cases of severe toxicity, chelation therapy with appropriate agents (e.g., deferoxamine) should be considered. Exchange transfusion may be indicated in life-threatening situations. Management should be guided by healthcare provider based on clinical status and laboratory parameters.

STORAGE AND HANDLING SECTION.

Do not use if the seal under the bottle cap is broken.KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.

USE IN SPECIFIC POPULATIONS SECTION.

USE IN SPECIFIC POPULATIONS:. The formulas safety and efficacy have not been established in certain populations. Safety and effectiveness in pregnant or nursing women, pediatric patients, and geriatric patients have not been established. Use in these populations should be under the supervision of healthcare provider.

WARNINGS SECTION.

WARNING:. Accidental overdose of iron-containing products is leading cause of fatal poisoning in children under 6. Keep this product out of reach of children. In case of accidental overdose, call doctor or poison control center immediately. Administration of folate alone is improper therapy for pernicious anemia and other megaloblastic anemias in which vitamin B12 is deficient.