TRIVEEN-DUO DHA- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopheryol acetate-dl, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, ferrous bisglycinate, iron protein succinylate, magnesium oxide, zinc oxide, cupric oxide, and doconexent
Trigen Laboratories, Inc.
DESCRIPTION
Triveen�-Duo DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules. The Triveen�-Duo DHA tablet is a yellow, oval tablet debossed with "T591″ on one side. The DHA softgel capsule is a clear, oblong softgel capsule containing pale yellow oil.
INDICATION
Triveen�-Duo DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, 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. Triveen�-Duo DHA is also useful in improving nutritional status prior to conception.
The daily regimen of Triveen�-Duo DHA contains:
(1)
Triveen�-Duo DHA prenatal vitamin tablet plus
(1)
Softgel capsule containing at least 275mg of DHA.
�
400mg of omega-3 fatty acids.
�
15 vitamins and minerals - including 1mg folic acid.
�
25mg of vitamin B6 .
As with any prescription strength product containing folic acid, omega-fatty acids, iron or the non-water soluble Vitamin D and E, adhere carefully to the dosages prescribed by your physician.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients includingfish 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. Since daily ingestion of more than 3 grams per day of omega-3 fatty acids (including alpha linolenic acid (ALA), eicosapentaenoic acid (EPA) 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.
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.
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.
Supplement FactsServings per Carton: 30
Serving Size: 1 Tablet and 1 Softgel CapsuleEach Tablet contains %DV for Pregnant and Lactating Women
Vitamin A (beta carotene) 3000 IU 38%
Vitamin C (ascorbic acid) 120 mg 200%
Vitamin D (cholecalciferol) 400 IU 100%
Vitamin E (dl-alpha-tocopheryl acetate) 30 mg 177%
Vitamin B1 (thiamine mononitrate) 1.8 mg 106%
Vitamin B2 (riboflavin) 4 mg 200%
Niacinamide 20 mg 100%
Vitamin B6 (pyridoxine HCl) 25 mg 1000%
Folic Acid 1 mg 125%
Vitamin B12 (cyanocobalamin) 12 mcg 150%
Calcium (calcium carbonate) 200 mg 15%
Iron (ferrous bisglycinate HCl and iron protein succinylate) 29 mg 161%
Magnesium (magnesium oxide) 25 mg 6%
Zinc (zinc oxide) 25 mg 167%
Copper (cupric oxide) 2 mg 100%
Each oblong DHA soft gelatin capsule contains: 400 mg purified omega-3 fatty acids including: at least 275 mg DHA (docosahexaenoic acid); also contains EPA (eicosapentaenoic) and other omega-3 fatty acids.
Inactive Ingredients
Triveen�-Duo DHA Tablet: Microcrystalline Cellulose, Croscarmellose Sodium, TriPotassium Citrate, Hypromellose, Citric Acid, Acacia, Titanium Dioxide, Povidone K30, Fumed Silica, Magnesium Stearate, Stearic Acid, Polyethylene Glycol, Ethyl Cellulose, Talc, Polysorbate 80, FD&C Yellow #5 Lake, Vegetable Oil, Hydroxypropyl Cellulose, FD&C #6 Yellow Lake.
Triveen�-Duo DHA Softgel: Gelatin, Glycerin, Purified Water and Vitamin E.
DOSAGE AND ADMINISTRATION
Before, during and after pregnancy, one tablet and one softgel taken by mouth daily, or as directed by a physician. The tablet and softgel capsule may be taken together or at different times of the day. Caution should be excercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.
HOW SUPPLIED
Triveen�-Duo DHA is supplied in child-resistant unit-dose blister cards containing 6 Triveen�-Duo DHA tablets and 6 DHA softgel capsules per card. Each unit-of-use dispensing carton contains 5 unit-dose blister cards which is a 30-day supply.
PRODUCT CODE: 13811-591-30
Rx Only
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 discolorations of the tablet.
KEEP OUT OF REACH OF CHILDREN.
Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).
All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalences.
See package insert for prescribing and product information.
