Duet DHA

Manufacturer
Eckson Labs, LLC
Effective date
2023-09-07
Label type
HUMAN PRESCRIPTION DRUG LABEL
Version
4
Source
legacy-cache
Hydrated at
2026-08-01 21:26:24

Label at a glance#

ProductDuet DHA 400
Active ingredient.BETA.-CAROTENE, ASCORBIC ACID, CHOLECALCIFEROL, .ALPHA.-TOCOPHEROL ACETATE, D-, THIAMINE MONONITRATE, RIBOFLAVIN, NIACINAMIDE, PYRIDOXINE HYDROCHLORIDE, FOLIC ACID, CYANOCOBALAMIN, CALCIUM CARBONATE, IRON, MAGNESIUM OXIDE, ZINC OXIDE, CUPRIC OXIDE, IODINE, OMEGA-3 FATTY ACIDS
Label structure11 sections

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.

Storage and handling

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: Eckson Labs,...

Label contents#

Full prescribing information#

DESCRIPTION:

DESCRIPTION SECTION

This product is a gluten free prescription regimen of prenatal multi-vitamin, multi-mineral and omega-3 fatty acids, supplied as tablets and softgel capsules.

Each tablet contains:

Supplement Facts
Serving Size: 1 Tablet
Amount Per Serving
Vitamin A (beta carotene)2,800 IU
Vitamin C (ascorbic acid)120 mg
Vitamin D (cholecalciferol)820 IU
Vitamin E (dl-alpha tocopheryl acetate)3 mg
Vitamin B 1 (thiamine mononitrate) 1.8 mg
Vitamin B 2 (riboflavin) 4 mg
Niacinamide20 mg
Vitamin B 6 (pyridoxine hydrochloride) 50 mg
Folic acid1 mg
Vitamin B 12 (cyanocobalamin) 12 mcg
Calcium (calcium carbonate)200 mg
Iron (polysaccharide iron complex and sodium iron (III) ethylenediaminetetraacetate, Ferrazone ®) 25 mg
Magnesium (magnesium oxide)25 mg
Zinc (zinc oxide)25 mg
Copper (cupric oxide)2 mg
Iodine220 mcg

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 400 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid) and EPA (eicosapentaenoic acid).

Supplement Facts
Serving Size: 1 Softgel Capsule
Amount Per Serving
Total omega-3 long-chain fatty acids (as DHA and EPA)400 mg

OTHER INGREDIENTS: gelatin, glycerin, purified water

INDICATIONS:

INDICATIONS & USAGE SECTION

This product is a gluten free 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. This product is also useful in improving the nutritional status prior to conception.

CONTRAINDICATIONS:

CONTRAINDICATIONS SECTION

This product is contraindicated in patients with known hypersensitivity to any of the ingredients, including fish or fish oil.

WARNINGS:

WARNINGS SECTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B 12 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.

KEEP OUT OF REACH OF CHILDREN.

PRECAUTIONS:

PRECAUTIONS SECTION

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:

DRUG INTERACTIONS SECTION

Pyridoxine supplements should be avoided in patients receiving levodopa alone, as the actions of levodopa may be antagonized.

ADVERSE REACTIONS:

ADVERSE REACTIONS SECTION

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

DOSAGE AND ADMINISTRATION:

DOSAGE & ADMINISTRATION SECTION

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:

HOW SUPPLIED SECTION

A 30-day regimen supplied in a carton, NDC 44118-807-30, consisting of one bottle containing 30 maroon tablets, imprinted “800”, and one bottle containing 30 softgel capsules. These child-resistant bottles are tamper evident by foil seal under cap.

STORAGE:

STORAGE AND HANDLING SECTION

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:
Eckson Labs, LLC
1000 N. West St., Suite 1200, #927
Wilmington, DE 19801

Ferrazone® is a registered trademark of AkzoNobel b v

1800009 v1 Rev. 07/2018

PACKAGE LABEL.PRINCIPAL DISPLAY PANEL

carton.jpgcarton.jpg

DailyMed Billing Units#

Package NDC, Billing unit, Product NDC table
Package NDCBilling unitProduct NDCDailyMed indexing SPLSPL versionEffective
44118-807-30EA - Each44118-807851aabc6-71c7-4f2b-8de9-51f72f2c31f112013-07-02

DailyMed Socrata Ingredients#

Ingredient, Type, UNII table
IngredientTypeUNIISPL versionUploaded
.ALPHA.-TOCOPHEROL ACETATE, D-ACTIVE INGREDIENTA7E6112E4N1
.BETA.-CAROTENEACTIVE INGREDIENT01YAE03M7J1
ASCORBIC ACIDACTIVE INGREDIENTPQ6CK8PD0R1
CALCIUM CARBONATEACTIVE INGREDIENTH0G9379FGK1
CHOLECALCIFEROLACTIVE INGREDIENT1C6V77QF411
CUPRIC OXIDEACTIVE INGREDIENTV1XJQ704R41
CYANOCOBALAMINACTIVE INGREDIENTP6YC3EG2041
FOLIC ACIDACTIVE INGREDIENT935E97BOY81
IODINEACTIVE INGREDIENT9679TC07X41
IRONACTIVE INGREDIENTE1UOL152H71
MAGNESIUM OXIDEACTIVE INGREDIENT3A3U0GI71G1
NIACINAMIDEACTIVE INGREDIENT25X51I8RD41
OMEGA-3 FATTY ACIDSACTIVE INGREDIENT71M78END5S1
PYRIDOXINE HYDROCHLORIDEACTIVE INGREDIENT68Y4CF58BV1
RIBOFLAVINACTIVE INGREDIENTTLM2976OFR1
THIAMINE MONONITRATEACTIVE INGREDIENT8K0I04919X1
ZINC OXIDEACTIVE INGREDIENTSOI2LOH54Z1
.ALPHA.-TOCOPHEROL, D-ACTIVE MOIETYN9PR3490H91
.BETA.-CAROTENEACTIVE MOIETY01YAE03M7J1
ASCORBIC ACIDACTIVE MOIETYPQ6CK8PD0R1
CALCIUM CATIONACTIVE MOIETY2M83C4R6ZB1
CHOLECALCIFEROLACTIVE MOIETY1C6V77QF411
CUPRIC CATIONACTIVE MOIETY8CBV67279L1
CYANOCOBALAMINACTIVE MOIETYP6YC3EG2041
FOLIC ACIDACTIVE MOIETY935E97BOY81
IODINEACTIVE MOIETY9679TC07X41
IRONACTIVE MOIETYE1UOL152H71
MAGNESIUM CATIONACTIVE MOIETYT6V3LHY8381
NIACINAMIDEACTIVE MOIETY25X51I8RD41
OMEGA-3 FATTY ACIDSACTIVE MOIETY71M78END5S1
PYRIDOXINEACTIVE MOIETYKV2JZ1BI6Z1
RIBOFLAVINACTIVE MOIETYTLM2976OFR1
THIAMINE IONACTIVE MOIETY4ABT0J945J1
ZINC CATIONACTIVE MOIETY13S1S8SF371
.ALPHA.-TOCOPHEROL, D-INACTIVE INGREDIENTN9PR3490H91
CELLULOSE, MICROCRYSTALLINEINACTIVE INGREDIENTOP1R32D61U1
ETHYL VANILLININACTIVE INGREDIENTYC9ST449YJ1
FD&C BLUE NO. 1INACTIVE INGREDIENTH3R47K3TBD1
FD&C BLUE NO. 2INACTIVE INGREDIENTL06K8R7DQK1
FD&C RED NO. 40INACTIVE INGREDIENTWZB9127XOA1
GELATININACTIVE INGREDIENT2G86QN327L1
GLYCERININACTIVE INGREDIENTPDC6A3C0OX1
MAGNESIUM STEARATEINACTIVE INGREDIENT70097M6I301
POLYETHYLENE GLYCOLSINACTIVE INGREDIENT3WJQ0SDW1A1
POLYVINYL ALCOHOLINACTIVE INGREDIENT532B59J9901
SILICON DIOXIDEINACTIVE INGREDIENTETJ7Z6XBU41
STARCH, CORNINACTIVE INGREDIENTO8232NY3SJ1
TALCINACTIVE INGREDIENT7SEV7J4R1U1
TITANIUM DIOXIDEINACTIVE INGREDIENT15FIX9V2JP1
WATERINACTIVE INGREDIENT059QF0KO0R1

Products#

Every source-derived product name is available through these pages.

DailyMed product names page 1 of 2 · 45 matching rows.

NDC Codes#

Product NDC, Package NDC table
Product NDCPackage NDC
44118-80744118-807-30
44118-80344118-803-30
44118-80544118-805-30

Ingredients#

Every source-derived ingredient row is available through these pages.

DailyMed ingredient rows page 1 of 1 · 33 matching rows.

Source Document#

Source XML · Source PDF

Inactive ingredient matches#

Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.

Inactive ingredient links page 1 of 8 · 430 matching rows.

DailyMed ingredient, IID ingredient, UNII table
DailyMed ingredientIID ingredientUNIIDosage form / routePotencyMaximum daily exposureMatch
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCAPSULE, DELAYED RELEASE / ORAL2 mgExact identifier — unii candidate
37 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, CHEWABLE, EXTENDED RELEASE / ORAL144 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE / RESPIRATORY (INHALATION)NAExact identifier — unii candidate
40 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61USUSPENSION / ORAL1600 mgExact identifier — unii candidate
28 equally ranked IID candidates
GELATINGELATIN2G86QN327LGUM, CHEWING / BUCCAL102 mgExact identifier — unii candidate
44 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPTABLET, ORALLY DISINTEGRATING, DELAYED RELEASE / ORAL42 mgExact identifier — unii candidate
40 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, COATED, EXTENDED RELEASE / ORALNAExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UGRANULE, DELAYED RELEASE / ORAL525 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET / RECTAL32.4 mgExact identifier — unii candidate
35 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXINJECTION, EMULSION / INTRAVENOUS24100 mgExact identifier — unii candidate
75 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER / ORAL25 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDLIQUID / TOPICALNAExact identifier — unii candidate
37 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, CHEWABLE / ORAL254 mgExact identifier — unii candidate
49 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGUM, CHEWING / BUCCAL230 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXAEROSOL / TOPICAL3 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOASUSPENSION/ DROPS / ORAL1 mgExact identifier — unii candidate
28 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPPASTE / DENTAL0.5 %w/wExact identifier — unii candidate
40 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4FILM, EXTENDED RELEASE / TRANSDERMAL49 mgExact identifier — unii candidate
49 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED PELLETS / ORAL4.4 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOACAPSULE, COATED PELLETS / ORALNAExact identifier — unii candidate
28 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE, DELAYED RELEASE / ORAL216 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30TABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
39 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXELIXIR / ORAL5621 mgExact identifier — unii candidate
75 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSPRAY / NASAL22.3 mg/1mlExact identifier — unii candidate
75 equally ranked IID candidates
TALCTALC7SEV7J4R1UPELLET / ORAL69 mgExact identifier — unii candidate
35 equally ranked IID candidates
TALCTALC7SEV7J4R1UELIXIR / ORAL4.5 mg/5mlExact identifier — unii candidate
35 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPLOTION / TOPICALNAExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, COATED / ORAL256 mgExact identifier — unii candidate
22 equally ranked IID candidates
GELATINGELATIN2G86QN327LSUPPOSITORY / VAGINALNAExact identifier — unii candidate
44 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET / ORAL27.53 mgExact identifier — unii candidate
37 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXSYRUP / ORAL16734 mgExact identifier — unii candidate
75 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UGRANULE / ORAL29520 mgExact identifier — unii candidate
28 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTROCHE / ORAL300 mgExact identifier — unii candidate
28 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET / SUBLINGUAL10 mgExact identifier — unii candidate
49 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDSOLUTION / DENTALNAExact identifier — unii candidate
37 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET, DELAYED RELEASE / ORAL2210 mgExact identifier — unii candidate
28 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDCONCENTRATE / BUCCALNAExact identifier — unii candidate
37 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPCAPSULE, COATED / ORAL17 mgExact identifier — unii candidate
40 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJTABLET, FILM COATED / ORAL2000 mgExact identifier — unii candidate
22 equally ranked IID candidates
GELATINGELATIN2G86QN327LPOWDER / ORAL100 mgExact identifier — unii candidate
44 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJCAPSULE / ORAL5785 mgExact identifier — unii candidate
22 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30GRANULE / ORAL629 mgExact identifier — unii candidate
39 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4GRANULE / ORAL5000 mgExact identifier — unii candidate
49 equally ranked IID candidates
GELATINGELATIN2G86QN327LCAPSULE, LIQUID FILLED / ORAL1042 mgExact identifier — unii candidate
44 equally ranked IID candidates
SILICON DIOXIDESILICON DIOXIDEETJ7Z6XBU4TABLET, FILM COATED, EXTENDED RELEASE / ORAL336 mgExact identifier — unii candidate
49 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30RING / VAGINAL2 mgExact identifier — unii candidate
39 equally ranked IID candidates
TITANIUM DIOXIDETITANIUM DIOXIDE15FIX9V2JPFILM / BUCCAL3 mgExact identifier — unii candidate
40 equally ranked IID candidates
FD&C BLUE NO. 1FD&C BLUE NO. 1H3R47K3TBDTABLET, SUGAR COATED / ORALNAExact identifier — unii candidate
37 equally ranked IID candidates
GELATINGELATIN2G86QN327LPASTE / DENTAL252 mgExact identifier — unii candidate
44 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / TRANSDERMAL500 mgExact identifier — unii candidate
75 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / BUCCAL18 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30CAPSULE, DELAYED RELEASE / ORAL1060 mgExact identifier — unii candidate
39 equally ranked IID candidates
FD&C RED NO. 40FD&C RED NO. 40WZB9127XOATABLET / ORAL7 mgExact identifier — unii candidate
28 equally ranked IID candidates
GLYCERINGLYCERINPDC6A3C0OXGEL / OPHTHALMIC0.88 %w/wExact identifier — unii candidate
75 equally ranked IID candidates
GELATINGELATIN2G86QN327LTABLET, DELAYED RELEASE / ORAL19 mgExact identifier — unii candidate
44 equally ranked IID candidates
CELLULOSE, MICROCRYSTALLINEMICROCRYSTALLINE CELLULOSEOP1R32D61UTABLET / ORAL6184 mgExact identifier — unii candidate
28 equally ranked IID candidates
MAGNESIUM STEARATEMAGNESIUM STEARATE70097M6I30POWDER, FOR SUSPENSION / ORAL120 mgExact identifier — unii candidate
39 equally ranked IID candidates
GELATINGELATIN2G86QN327LSOLUTION / ORAL34.8 mgExact identifier — unii candidate
44 equally ranked IID candidates
TALCTALC7SEV7J4R1UTABLET, ORALLY DISINTEGRATING / ORAL80 mgExact identifier — unii candidate
35 equally ranked IID candidates
STARCH, CORNSTARCH, CORNO8232NY3SJINSERT / VAGINAL147 mgExact identifier — unii candidate
22 equally ranked IID candidates

openFDA label cross-check#

OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.

Matched openFDA labels page 1 of 1 · 1 matching rows.

Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
04c70e1e-a02c-879a-e063-6394a90a13fb9532f8de-115c-4f37-9148-2e6899800f652023-09-07Warnings, Adverse reactionsExact identifier
spl id: 04c70e1e-a02c-879a-e063-6394a90a13fb
spl set id: 9532f8de-115c-4f37-9148-2e6899800f65

Reported adverse events (FAERS/openFDA)#

Adverse event summaries are temporarily unavailable. Other product information remains available.