Data from FDA - Curated by EPG Health - Last updated 30 August 2017

Indication(s)

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.

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Advisory information

contraindications
CONTRAINDICATIONS TriStart DHA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients.
Special warnings and precautions
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
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

Usage information

Dosing and administration
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.

More information

Category Value
Agency product number 1VZZ62R081
Orphan designation No
Product NDC 15370-250
Date Last Revised 04-06-2015
Type HUMAN PRESCRIPTION DRUG
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.
Marketing authorisation holder CarWin Pharmaceutical Associates, LLC
Warnings 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.