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TriStart DHA (ascorbic acid 55 mg cholecalciferol 1000 [iu] .alpha.-tocopherol acetate, d- 15 [iu] thiamine hydrochloride 1.3 mg riboflavin 1.8 mg niacin 5 mg pyridoxine hydrochloride 35 mg levomefolate magnesium 600 ug folic acid 400 ug cyanocobalamin 14 ug iron pentacarbonyl 31 mg potassium iodide 200 ug magnesium oxide 30 mg doconexent 200 mg icosapent 15 mg) Dailymed



IMPRINT: TRISTART     SHAPE: oval
    COLOR: brown

Boxed Warning

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.


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Description Section

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 DHAâ„¢ Softgel capsules are dye free, lactose, gluten and sugar free. They do not contain any artificial flavors or sweeteners. TriStart DHAâ„¢ contains bovine gelatin.

Indications


TriStart DHAâ„¢ 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 DHAâ„¢ 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.

Contraindications


TriStart DHAâ„¢ is contraindicated in patients with a known hypersensitivity to any of the ingredients.

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.

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.

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.

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

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


TriStart DHAâ„¢ 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).

STORAGE AND HANDLING SECTION


Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature.]

TriStart DHAâ„¢ 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.


Manufactured for: CarWin Pharmaceutical Associates, LLC Slidell, LA 70461

RxMADE IN CANADA

Rev. 05/2015

Principal Display Panel - 30 Capsule Bottle Label


15370-250-30

TriStart DHA PRENATAL SUPPLEMENT

Dye Free, Lactose, Glutenand Sugar Free

Rx 30 Softgels

DISCLAIMER:

"This tool does not provide medical advice, and is for informational and educational purposes only, and is not a substitute for professional medical advice, treatment or diagnosis. Call your doctor to receive medical advice. If you think you may have a medical emergency, please dial 911."

"Do not rely on openFDA to make decisions regarding medical care. While we make every effort to ensure that data is accurate, you should assume all results are unvalidated. We may limit or otherwise restrict your access to the API in line with our Terms of Service."

"This product uses publicly available data from the U.S. National Library of Medicine (NLM), National Institutes of Health, Department of Health and Human Services; NLM is not responsible for the product and does not endorse or recommend this or any other product."

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