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, LLC
----------
Triveen™-Duo DHA
SUPPLEMENT FACTS
Multivitamin/Multimineral Tablet
Other Ingredients: Tablet: Microcrystalline Cellulose, Yellow Coating (Hypromellose, Titanium Dioxide, Polyvinyl Alcohol, Polyethylene Glycol,Talc, FD&C Yellow #5 Lake, FD&C Yellow #6 Lake, FD&C Blue #2 Lake) Croscarmellose Sodium, Tripotassium Citrate, Citric Acid, Acacia, Povidone K30, Fumed Silica, Magnesium Stearate and Stearic Acid.
Omega-3 Fatty Acid Capsule
Other Ingredients: Vegetarian Softgel: Modified Food Starch, Carrageenan, Sorbitol, Glycerin, and Purified Water.
THIS PRODUCT CONTAINS FISH OIL (ANCHOVY).
Triveen™-Duo DHA is a prescription prenatal multivitamin/ multimineral and omega-3 fatty acid supplement indicated for use in improving the nutritional status of women prior to conception, throughout pregnancy, and in the post-natal period for both lactating and non-lactating mothers.
CONTRAINDICATIONS
This product is contraindicated in patients with known hypersensitivity to any of the ingredients including fish oil.
WARNINGS
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.
| 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. |
PRECAUTIONS
General: 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 remain progressive.
The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.
This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible persons. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.
Pediatric Use: Safety and effectiveness in pediatric patients have not been established
Geriatric Use: Safety and effectiveness in elderly populations have not been established.
DRUG INTERACTIONS
Triveen™-Duo DHA is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).
ADVERSE REACTIONS
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DESCRIPTION
Triveen™-Duo DHA tablet is a yellow, oval tablet imprinted with “T591” on one side. Triveen™-Duo DHA softgel capsule is a clear, oval softgel containing yellow oil.
DIRECTIONS FOR USE
Take one tablet and one soft gelatin capsule by mouth daily, or as prescribed by a physician. The tablet and soft gelatin capsule may be taken together or at different times of the day.
HOW SUPPLIED
Triveen™-Duo DHA is supplied in a 30 day child-resistant unit-of-use dispensing carton containing 5 blister cards of 6 tablets and 6 soft gelatin capsules each.
Product Code: 13811-591-30
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 OUT OF REACH OF CHILDREN.
For use on the order of a healthcare practitioner.
Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088.
Customer Service: 1-877-482-3788 Rev. 08/2019
Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807
www.trigenlab.com
| 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 kit |
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Trigen Laboratories, LLC (830479668) |