TRICARE PRENATAL DHA ONE - multivitamin/mineral capsule, gelatin coated
Medecor Pharma, LLC
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
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TriCare® Prenatal DHA ONE® Softgel
Description:
Each purple softgel contains:
| Essential Fatty Acids |
|
| Fish Oil Concentrate 10/50 TG | 500 mg |
| DHA | 215 mg |
| EPA | 45 mg |
| Vitamins |
|
| Vitamin B-1 (Thiamine Nitrate) | 3 mg |
| Vitamin B-2 (Riboflavin) | 3.4 mg |
| Vitamin B-3 (Inositol Nicotinate) | 20 mg |
| Vitamin B-6 (Pyridoxine Hydrochloride) | 25 mg |
| Vitamin B-12 (Cyanocobalamin) | 100 mcg |
| Folic Acid | 1 mg |
| Vitamin C (Ascorbic Acid) | 60 mg |
| Vitamin D3 (Cholecalciferol) | 800 IU |
| Vitamin E (d-alpha-Tocopherol) | 30 IU |
| Biotin | 300 mcg |
| Minerals |
|
| Iron (Ferrous Fumarate) | 27 mg |
| Zinc (Zinc Sulfate Monohydrate) | 10 mg |
| Copper (Cupric Sulfate Anhydrous) | 2 mg |
| Docusate Sodium | 25 mg |
INACTIVE INGREDIENTS:
Gelatin, Glycerol, Hydrogenated Vegetable Oil, Purified Water, Yellow Beeswax, Lecithin, Colloidal Anhydrous Silica, Ethanol, Natural Lime Oil Ordinary 479208/ARTG 1258, Cochineal C175470, Lemon Oil, Titanium Dioxide, Polysorbate 80, Brilliant Blue FCF C142090
INDICATIONS AND USAGE:
TriCare® Prenatal DHA ONE® Multivitamin/Mineral softgels are indicated to provide multivitamin/mineral/essential fatty acid supplementation throughout pregnancy and during the postnatal period for both the lactating and non-lactating mother. It is also useful for improving nutritional status prior to conception.
CONTRAINDICATIONS:
This product 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.
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B-12 is deficient.
PRECAUTIONS:
Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress.
ADVERSE REACTIONS:
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
HOW SUPPLIED:
TriCare® Prenatal DHA ONE® Multivitamin/Mineral Softgels for oral administration are supplied as purple softgels, imprinted in gray ink: TriCare DHA 401 in a child-resistant plastic bottle of 90 softgels. (NDC 67112-401-90).
WARNING:
Ingestion of more than 3 grams of Omega-3 fatty acids (such as DHA) 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 aniticoagulants and in those known to have an inherited or acquired predisposition to bleeding.
| TRICARE PRENATAL DHA ONE
multivitamin/mineral capsule, gelatin coated |
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| Labeler - Medecor Pharma, LLC (830621046) |
| Registrant - Medecor Pharma, LLC (830621046) |
| Establishment | |||
| Name | Address | ID/FEI | Business Operations |
|---|---|---|---|
| Catalent Australia PTY LTD | 753617638 | manufacture | |