Vena-Bal DHA by Trigen Laboratories, Inc. Vena-Bal DHA
Vena-Bal DHA by
Drug Labeling and Warnings
Vena-Bal DHA by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, Inc.. Drug facts, warnings, and ingredients follow.
Drug Details [pdf]
VENA-BAL DHA- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, potassium iodide, iron, magnesium oxide, zinc oxide, cupric oxide and omega-3 fatty acids
Trigen Laboratories, LLC
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Vena-Bal DHA
DESCRIPTION
Vena-Bal DHA is a gluten free prescription regimen of prenatal multivitamin, multimineral, and omega-3 fatty acids, supplied as tablets and enteric coated softgel capsules. The Vena-Bal DHA tablet is a yellow, oval tablet debossed "TL601". The enteric-coated DHA softgel capsule is a clear, oblong softgel capsule containing pale yellow oil.
| Supplement Facts Servings per Carton: 30 |
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|---|---|---|
| Serving Size: 1 Tablet Each Tablet contains | %DV for Pregnant and Lactating Women |
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| Vitamin A (beta carotene) | 2850 IU | 36% |
| Vitamin C (ascorbic acid) | 120 mg | 200% |
| Vitamin D (cholecalciferol) | 840 IU | 210% |
| Vitamin E (dl-alpha-tocopheryl acetate) | 3 mg | 18% |
| Vitamin B1 (thiamine mononitrate) | 1.8 mg | 106% |
| Vitamin B2 (riboflavin) | 4 mg | 200% |
| Niacinamide | 20 mg | 100% |
| Vitamin B6 (pyridoxine HCl) | 50 mg | 2000% |
| Folic Acid | 1 mg | 125% |
| Vitamin B12 (cyanocobalamin) | 12 mcg | 150% |
| Calcium (calcium carbonate) | 219 mg | 17% |
| Iron (sodium iron EDTA & polysaccharide iron complex) | 27 mg | 150% |
| Magnesium (magnesium oxide) | 25 mg | 6% |
| Zinc (zinc oxide) | 25 mg | 167% |
| Copper (cupric oxide) | 2 mg | 100% |
| Iodine | 220 mcg | 147% |
Inactive Ingredients(Vena-Bal DHA Tablet): Microcrystalline Cellulose, Hypromellose, TriPotassium Citrate, Croscarmellose Sodium, Titanium Dioxide, Acacia, Citric Acid, Povidone K30, Stearic Acid, Magnesium Stearate, Polyethylene Glycol, Ethyl Cellulose, Talc, Fumed Silica, Polysorbate 80, FD&C Yellow #5 Lake, Mineral Oil, Hydroxypropyl Cellulose, Ascorbyl Palmitate, FD&C Yellow #6 Lake.
Each oblong, Enteric-coated DHA Softgel Capsule contains: Not less than 430 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), and DPA (docasapentaenoic acid) in approximately 628 mg of fish oil.
| OMEGA-3 FATTY ACIDS | |
| Total Omega-3 long-chain fatty acids | No less than 430 mg |
| As DHA | No less than 295 mg |
| As other omega-3 long-chain fatty acids | No less than 135 mg |
Inactive Ingredients (Enteric-coated DHA Softgel Capsule): Gelatin, Glycerin, Purified Water, Enteric Coating (Dewaxed Shellac USP, Sodium Aliginate, Ammonium Hydroxide, Glycerin, Acetylated Monoglycerides, Polysorbate 80, Potassium Sorbate, and Carnauba Wax)
INDICATIONS
Vena-Bal DHA is a gluten free prescription regimen of prenatal multivitamin, multimineral, and omega-3 fatty acid supplements indicated for use in improving the nutritional status of women throughout pregnancy and in the post-natal period for both lactating and non-lactating mothers. Vena-Bal DHA is also useful in improving the nutritional status prior to conception.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.
WARNINGS
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
| 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. |
THIS PRODUCT CONTAINS FISH OIL.
Since daily ingestion of more than 3 grams per day of omega-3 fatty acids [including alpha-linolenic acid (ALA), and docosahexaenoic acid (DHA)] from fish oils may have potential antithrombotic activities and may increase bleeding times, administration of DHA should be avoided in patients with inherited or acquired bleeding diatheses, including those taking anticoagulants.
PRECAUTIONS
Folic acid in doses above 0.1 mg daily may obscure the diagnosis of pernicious anemia (hematologic remission may occur while neurological manifestations remain progressive).
DRUG INTERACTIONS
Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION
Before, during and after pregnancy, One tablet and One enteric-coated softgel capsule taken by mouth daily, or as prescribed by a physician. The tablet and enteric-coated softgel capsule may be taken together or at different times of the day. Caution should be exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
HOW SUPPLIED
Vena-Bal DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 tablet and 1 enteric-coated DHA softgel capsule equals 1 daily dose). Each unit-of-use dispensing carton contains 5 cards with 6 unit-doses per card which is a 30-day supply.
PRODUCT CODE: 13811-601-30
STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discoloration of the tablet. Keep in a well-closed, light-resistant container as defined by the USP.
Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).
| VENA-BAL DHA
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol acetate, dl-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, potassium iodide, iron, magnesium oxide, zinc oxide, cupric oxide and omega-3 fatty acids kit |
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| Labeler - Trigen Laboratories, LLC (830479668) |