DUET DHA BALANCED- .beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline, omega-3 fatty acids kit

Duet DHA Balanced by

Drug Labeling and Warnings

Duet DHA Balanced by is a Prescription medication manufactured, distributed, or labeled by Eckson Labs, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Rx Only

DESCRIPTION:

This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega fatty acids, supplied as tablets and softgel capsules.

Each tablet contains:

• Vitamin A (beta carotene): 2,800 IU
• Vitamin C (ascorbic acid): 120 mg
• Vitamin D 3 (cholecalciferol): 640 IU
• Vitamin E (dl-alpha tocopheryl acetate): 15 mg
• Vitamin B 1 (thiamine mononitrate): 1.5 mg
• Vitamin B 2 (riboflavin): 2 mg
• Niacinamide: 20 mg
• Vitamin B 6 (pyridoxine HCl): 50 mg
• Folic acid: 1 mg
• Vitamin B 12 (cyanocobalamin): 12 mcg
• Calcium (calcium carbonate): 215 mg
• Iron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone ®): 25 mg
• Magnesium (magnesium oxide): 25 mg
• Zinc (zinc oxide): 25 mg
• Selenium (sodium selenate): 65 mcg
• Copper (cupric oxide): 1.8 mg
• Iodine (potassium iodide): 210 mcg
• Choline (choline bitartrate): 55 mg

Other ingredients: microcrystalline cellulose, starch, silica, magnesium stearate, polyethylene glycol, polyvinyl alcohol, titanium dioxide, talc, FD&C red no. 40 aluminum lake, FD&C blue no. 1 & no. 2 aluminum lake

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.

Each softgel capsule contains in a clear solution of 267 mg purified omega long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), DPA (docosapentaenoic acid) and ALA (alpha-linolenic acid):

• Total omega long-chain fatty acids (as DHA, EPA, DPA and ALA): 267 mg

Other ingredients: gelatin, rice bran oil, glycerin, purified water

INDICATIONS:

This product is a gluten-free prescription regimen of prenatal multi-vitamin, multi-mineral and omega 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. This product 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.

Since daily ingestion of more than 3 grams per day of omega-3 fatty acids, including ALA (alpha-linolenic acid), EPA (eicosapentaenoic acid) and DHA (docosahexaenoic acid), 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.

KEEP OUT OF REACH OF CHILDREN.

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 softgel capsule 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 exercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

HOW SUPPLIED:

A 30-day regimen supplied in a carton, NDC: 44118-750-30, containing 6 child-resistant blister cards. Each blister card contains 5 maroon Duet® tablets (imprinted “750”) and 5 softgel capsules. Tamper evident by foil seal.

STORAGE:

Store at controlled room temperature 20° to 25°C (68° to 77°F), excursions permitted to 15° to 30°C (59° to 86°F). Relative humidity not to exceed 65%. Protect from moisture, excessive heat and freezing. Note that contact with moisture may produce surface discoloration of the tablet.

To report a serious adverse event or obtain product information, call 1-855-899-4237.

www.DuetDHA.com

Manufactured for:
1000 N. West St., Suite 1200, #927
Wilmington, DE 19801

Ferrazone ® is a registered trademark of AkzoNobel b v

827582 v1 Rev. 08/2017

PRINCIPAL DISPLAY PANEL

INGREDIENTS AND APPEARANCE

DUET DHA BALANCED 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline, omega-3 fatty acids kit

Product Information
Product Type	HUMAN PRESCRIPTION DRUG	Item Code (Source)	NDC: 44118-750

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44118-750-30	1 in 1 CARTON; Type 0: Not a Combination Product	10/30/2012
2	NDC: 44118-750-05	1 in 1 CARTON; Type 0: Not a Combination Product	10/30/2012

Quantity of Parts
Part #	Package Quantity	Total Product Quantity
Part 1	1 BLISTER PACK	30
Part 2	1 BLISTER PACK	30

Part 1 of 2

DUET DHA BALANCED 
.beta.-carotene, ascorbic acid, cholecalciferol, .alpha.-tocopherol, d-, thiamine mononitrate, riboflavin, niacinamide, pyridoxine hydrochloride, folic acid, cyanocobalamin, calcium carbonate, iron, magnesium, zinc oxide, sodium selenate, cupric oxide, iodine, choline tablet

Product Information
Item Code (Source)	NDC: 44118-751
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	50 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	215 mg
IRON (UNII: E1UOL152H7) (IRON - UNII:E1UOL152H7)	IRON	25 mg
MAGNESIUM (UNII: I38ZP9992A) (MAGNESIUM - UNII:I38ZP9992A)	MAGNESIUM	25 mg
ZINC OXIDE (UNII: SOI2LOH54Z) (ZINC OXIDE - UNII:SOI2LOH54Z)	ZINC OXIDE	25 mg
SODIUM SELENATE (UNII: 5DQP25600A) (SELENATE ION - UNII:6X37R1DB70)	SODIUM SELENATE	65 ug
CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L)	CUPRIC CATION	1.8 mg
IODINE (UNII: 9679TC07X4) (IODINE - UNII:9679TC07X4)	IODINE	210 ug
CHOLINE (UNII: N91BDP6H0X) (CHOLINE - UNII:N91BDP6H0X)	CHOLINE	55 mg
.BETA.-CAROTENE (UNII: 01YAE03M7J) (.BETA.-CAROTENE - UNII:01YAE03M7J)	.BETA.-CAROTENE	2800 [iU]
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	120 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	640 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (UNII: A7E6112E4N) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	15 mg
THIAMINE MONONITRATE (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	THIAMINE MONONITRATE	1.5 mg
RIBOFLAVIN (UNII: TLM2976OFR) (RIBOFLAVIN - UNII:TLM2976OFR)	RIBOFLAVIN	2 mg
NIACINAMIDE (UNII: 25X51I8RD4) (NIACINAMIDE - UNII:25X51I8RD4)	NIACINAMIDE	20 mg

Inactive Ingredients
Ingredient Name	Strength
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
CELLULOSE, MICROCRYSTALLINE (UNII: OP1R32D61U)
TALC (UNII: 7SEV7J4R1U)
FD&C RED NO. 40 (UNII: WZB9127XOA)
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)
FD&C BLUE NO. 2 (UNII: L06K8R7DQK)
STARCH, CORN (UNII: O8232NY3SJ)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)
MAGNESIUM STEARATE (UNII: 70097M6I30)
POLYETHYLENE GLYCOL, UNSPECIFIED (UNII: 3WJQ0SDW1A)
POLYVINYL ALCOHOL (UNII: 532B59J990)

Product Characteristics
Color	red (MAROON)	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	750
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44118-751-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/30/2012

Part 2 of 2

DUET DHA BALANCED 
omega-3 fatty acids capsule, gelatin coated

Product Information
Item Code (Source)	NDC: 44118-752
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
OMEGA-3 FATTY ACIDS (UNII: 71M78END5S) (OMEGA-3 FATTY ACIDS - UNII:71M78END5S)	OMEGA-3 FATTY ACIDS	267 mg

Inactive Ingredients
Ingredient Name	Strength
GELATIN (UNII: 2G86QN327L)
RICE BRAN OIL (UNII: LZO6K1506A)
GLYCERIN (UNII: PDC6A3C0OX)
WATER (UNII: 059QF0KO0R)

Product Characteristics
Color	yellow	Score	no score
Shape	CAPSULE	Size	21mm
Flavor		Imprint Code	NONE
Contains

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 44118-752-30	30 in 1 BLISTER PACK; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/30/2012

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
unapproved drug other		10/30/2012

Labeler - Eckson Labs, LLC (078435242)