TriStart DHA
ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE HYDROCHLORIDE, RIBOFLAVIN, NIACIN, PYRIDOXINE HYDROCHLORIDE, LEVOMEFOLATE MAGNESIUM, FOLIC ACID, CYANOCOBALAMIN, IRON PENTACARBONYL, POTASSIUM IODIDE, MAGNESIUM OXIDE, DOCONEXENT, and ICOSAPENT · Capsule, Liquid Filled · Oral
Uses
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 and administration
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.
Contraindications
TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Warnings
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.
Side effects
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
Description
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.
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°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [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.
Storage
Store at 20°-25°C (68°-77°F); excursions permitted to 15°-30°C (59°-86°F) [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.
Label text from the FDA structured product label by CarWin Pharmaceutical Associates, LLC (revised Jan 9, 2024). Long sections are shortened; the complete label is on DailyMed.
Active ingredients
- Ascorbic Acid in 1 product
- Cholecalciferol in 1 product
- .alpha.-tocopherol Acetate, D- in 1 product
- Thiamine Hydrochloride in 1 product
- Riboflavin in 1 product
- Niacin in 1 product
- Pyridoxine Hydrochloride in 1 product
- Levomefolate Magnesium in 1 product
- Folic Acid in 1 product
- Cyanocobalamin in 1 product
- Iron Pentacarbonyl in 1 product
- Potassium Iodide in 1 product
TriStart DHA NDC products (1)
| NDC | Strength & form | Labeler | Type |
|---|---|---|---|
| 15370-250 | Ascorbic Acid 55 mg/1; Cholecalciferol 1000 [iU]/1; .alpha.-tocopherol Acetate, D- 15 [iU]/1; Thiamine Hydrochloride… Capsule, Liquid Filled | CarWin Pharmaceutical Associates, LLC | UNAPPROVED DRUG OTHER |
Frequently asked questions
What is TriStart DHA used for?
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…
What are the side effects of TriStart DHA?
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 See the full label for the complete list.
Who makes TriStart DHA?
TriStart DHA is listed by 1 labeler in the FDA NDC directory, including CarWin Pharmaceutical Associates, LLC.