PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.


PRINCIPAL DISPLAY PANEL 30 Capsule Bottle Label. 15370-250-30TriStartDHAPRENULLTAL SUPPLEMENTDye Free, Lactose, Glutenand Sugar FreeRx 30 Softgels Principal Display Panel 30 Capsule Bottle Label.

ADVERSE REACTIONS SECTION.


ADVERSE REACTIONS. Allergic sensitization has been reported following both oral and parenteral administration of folic acid.You should call your doctor for medical advice about serious adverse events. To report adverse side effects or to obtain product information, contact CarWin Pharmaceutical Associates, LLC at 1-985-288-5122.

BOXED WARNING 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.

CONTRAINDICATIONS SECTION.


CONTRAINDICATIONS. TriStart DHA(TM) is contraindicated in patients with known hypersensitivity to any of the ingredients.

DESCRIPTION SECTION.


Supplement FactsServing Size: SoftgelServings per container: 30Amount Per Serving%Daily Value%Daily Value for Pregnant and Lactating WomenVitamin C55 mg92%92% (as ascorbic acid)Vitamin D31000 IU250%250% (as cholecalciferol)Vitamin E15 IU50%50% (as d-alpha-tocopheryl acetate)Thiamin1.3 mg87%76% (as thiamine HCl, Vitamin B1)Riboflavin (Vitamin B2)1.8 mg106%90%Niacin (as nicotinic acid)5 mg25%25%Vitamin B635 mg1750%1400% (as pyridoxine HCl)Folate (as 630 mcg of L-Methylfolate Magnesium, molar equivalent to 600mcg of L-Methylfolic acid; and 400mcg of folic acid)1 mg250%125%Vitamin B1214 mcg233%175% (as cyanocobalamin)Iron (as carbonyl iron)31 mg172%172%Iodine200 mcg133%133% (as Potassium Iodide)Magnesium30 mg8%7% (as Magnesium Oxide)Docosahexaenoic Acid200mgDaily Values (DV) not established. (DHA)Eicosapentaenoate Acid15 mg (EPA)OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin.Contains: Soy and FishTriStart DHA(TM) Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA(TM) contains bovine gelatin.

DOSAGE & ADMINISTRATION SECTION.


DIRECTIONS. Adults. Take one softgel daily with or without food, or as prescribed by healthcare practitioner.. Children under 12. Consult doctor.Do not exceed the recommended dose.

HOW SUPPLIED SECTION.


HOW SUPPLIED. TriStart DHA(TM) is available as oval, brown softgel capsules with yellow imprint TriStart. They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in 3ct professional sample (15370-250-03).. Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F) [See USP Controlled Room Temperature.]TriStart DHA(TM) should be administered only under the direct supervision of healthcare practitioner.Avoid excessive heat, light and moisture.Keep out of reach of children.. Tamper Evident. Do not use if seal is broken or missing.

INDICATIONS & USAGE SECTION.


INDICATIONS. TriStart DHA(TM) is an orally administered multivitamin/multimineral fatty acid dietary supplement indicated to improve the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers. TriStart DHA(TM) can also be beneficial in improving the nutritional status of women prior to conception.This statement has not been evaluated by the Food and Drug Administration. This product is not intended to diagnose, treat, cure, or prevent disease.

PRECAUTIONS SECTION.


PRECAUTIONS. 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 neurological manifestations progress.Ingestion of more than grams of omega-3 fatty acids (such as DHA and EPA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

SPL UNCLASSIFIED SECTION.


Adults. Take one softgel daily with or without food, or as prescribed by healthcare practitioner.

STORAGE AND HANDLING SECTION.


Store at 20-25C (68-77F); excursions permitted to 15-30C (59-86F) [See USP Controlled Room Temperature.]TriStart DHA(TM) should be administered only under the direct supervision of healthcare practitioner.Avoid excessive heat, light and moisture.Keep out of reach of children.

WARNINGS SECTION.


Caution is recommended in patients taking anticonvulsant medications as folate may interfere with anticonvulsant medication, and may lower seizure threshold. Furthermore, anticonvulsant medications may interfere with folate metabolism.