BOXED WARNING 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.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL.
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label 15370-250-30 TriStart DHA PRENATAL SUPPLEMENT Dye Free, Lactose, Gluten and Sugar Free Rx 30 Softgels
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
INDICATIONS & USAGE SECTION.
INDICATIONS TriStart DHA 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 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.
DOSAGE & ADMINISTRATION SECTION.
DIRECTIONS Adults Take one softgel daily with or without food, or as prescribed by a healthcare practitioner. Children under 12 Consult a doctor. Do not exceed the recommended dose.
HOW SUPPLIED SECTION.
HOW SUPPLIED TriStart DHA is available as oval, brown softgel capsules with a yellow imprint "TriStart". They are available in child-resistant bottles containing 30 softgels (15370-250-30) and in a 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 should be administered only under the direct supervision of a 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.
SPL UNCLASSIFIED SECTION.
Manufactured for: CarWin Pharmaceutical Associates, LLC Slidell, LA 70461 Rx MADE IN CANADA Rev. 05/2015
Supplement Facts Serving Size: 1 Softgel Servings per container: 30 Amount Per Serving %Daily Value %Daily Value for Pregnant and Lactating Women Vitamin C 55 mg 92% 92% (as ascorbic acid) Vitamin D3 1000 IU 250% 250% (as cholecalciferol) Vitamin E 15 IU 50% 50% (as d-alpha-tocopheryl acetate) Thiamin 1.3 mg 87% 76% (as thiamine HCl, Vitamin B1) Riboflavin (Vitamin B2) 1.8 mg 106% 90% Niacin (as nicotinic acid) 5 mg 25% 25% Vitamin B6 35 mg 1750% 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 mg 250% 125% Vitamin B12 14 mcg 233% 175% (as cyanocobalamin) Iron (as carbonyl iron) 31 mg 172% 172% Iodine 200 mcg 133% 133% (as Potassium Iodide) Magnesium 30 mg 8% 7% (as Magnesium Oxide) Docosahexaenoic Acid 200mg Daily Values (DV) not established. (DHA) Eicosapentaenoate Acid 15 mg (EPA) OTHER INGREDIENTS: Gelatin (bovine), Glycerin, Purified Water, Yellow Bees Wax, Caramel Powder, Soy Lecithin, Natural Orange Flavor, Ethyl Vanillin. Contains: Soy and Fish TriStart DHA Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHA contains bovine gelatin.
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 3 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.
CONTRAINDICATIONS TriStart DHA is contraindicated in patients with a known hypersensitivity to any of the ingredients.
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.