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

Triveen-Duo DHA by

Drug Labeling and Warnings

Triveen-Duo DHA by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

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.

HEALTH CLAIM

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

PRINCIPAL DISPLAY PANEL - Kit Carton

13811-591-30

Triveen™-Duo DHA

30 Day Supply
30 tablets and 30 softgel capsules

TRIGEN
LABORATORIES

INGREDIENTS AND APPEARANCE

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

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-591

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-591-30	5 in 1 CARTON
1		1 in 1 BLISTER PACK

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	6
Part 2	1 BLISTER PACK	6

Part 1 of 2

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 tablet, film coated

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	3000 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	400 [iU]
.ALPHA.-TOCOPHEROL ACETATE, DL- (UNII: WR1WPI7EW8) (.ALPHA.-TOCOPHEROL, DL- - UNII:7QWA1RIO01)	.ALPHA.-TOCOPHEROL, DL-	15 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (Thiamine ION - UNII:4ABT0J945J)	THIAMINE	1.8 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	4 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1 mg
CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204)	CYANOCOBALAMIN	12 ug
CALCIUM CARBONATE (UNII: H0G9379FGK) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CARBONATE	200 mg
FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	25 mg
IRON PROTEIN SUCCINYLATE (UNII: VBJ9L90P4L) (IRON PROTEIN SUCCINYLATE - UNII:VBJ9L90P4L)	IRON PROTEIN SUCCINYLATE	4 mg
MAGNESIUM OXIDE (UNII: 3A3U0GI71G) (MAGNESIUM CATION - UNII:T6V3LHY838)	MAGNESIUM OXIDE	25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	2 mg

Inactive Ingredients
Ingredient Name	Strength
CASTOR OIL (UNII: D5340Y2I9G)
POTASSIUM CITRATE ANHYDROUS (UNII: 86R1NVR0HW)
CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)
HYPROMELLOSES (UNII: 3NXW29V3WO)
ACACIA (UNII: 5C5403N26O)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
POVIDONE K30 (UNII: U725QWY32X)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
STEARIC ACID (UNII: 4ELV7Z65AP)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
ETHYLCELLULOSES (UNII: 7Z8S9VYZ4B)
TALC (UNII: 7SEV7J4R1U)
HYDROXYPROPYL CELLULOSE (1600000 WAMW) (UNII: RFW2ET671P)
FD&C YELLOW NO. 5 (UNII: I753WB2F1M)
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)
MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 in 1 CARTON
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		11/01/2010

Part 2 of 2

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 capsule

Product Information
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	275 mg

Inactive Ingredients
Ingredient Name	Strength
MODIFIED CORN STARCH (1-OCTENYL SUCCINIC ANHYDRIDE) (UNII: 461P5CJN6T)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)
CARRAGEENAN (UNII: 5C69YCD2YJ)
SORBITOL (UNII: 506T60A25R)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1		5 in 1 CARTON
1		6 in 1 BLISTER PACK

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		11/01/2010

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		11/01/2010

Labeler - Trigen Laboratories, LLC (830479668)