FDA Label for Tristart Dha
View Indications, Usage & Precautions
Tristart Dha Product Label
The following document was submitted to the FDA by the labeler of this product Carwin Pharmaceutical Associates, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
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.
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.
Contraindications
TriStart DHA™ 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
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
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 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).
Storage And Handling
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.
Other
Manufactured for:
CarWin Pharmaceutical Associates, LLC
Slidell, LA 70461
Rx
MADE IN CANADA
Rev. 05/2015
Principal Display Panel - 30 Capsule Bottle Label
15370-250-30
TriStart
DHA
PRENATAL SUPPLEMENT
Dye Free, Lactose, Gluten
and Sugar Free
Rx
30 Softgels
* Please review the disclaimer below.