DuetDHA Balanced: Package Insert / Prescribing Information - Drugs.com

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# DuetDHA Balanced

Package insert / prescribing information
Generic name: prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids
Dosage form: tablets / capsules

Medically reviewed by Drugs.com. Last updated on Nov 21, 2022.

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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:

Supplement Facts Serving Size: 1 Tablet |
| Amount Per Serving
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):

Supplement Facts Serving Size: 1 Softgel Capsule |
| Amount Per Serving
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

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 LABEL | Item Code (Source) | NDC:44118-750

Packaging
# | Item Code | Package Description
1 | NDC:44118-750-30 | 1 KIT in 1 CARTON
2 | NDC:44118-750-05 | 1 KIT in 1 CARTON

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 | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) | PYRIDOXINE HYDROCHLORIDE | 50 mg
FOLIC ACID (FOLIC ACID) | FOLIC ACID | 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) | CYANOCOBALAMIN | 12 ug
CALCIUM CARBONATE (CALCIUM CATION) | CALCIUM CARBONATE | 215 mg
IRON (IRON) | IRON | 25 mg
MAGNESIUM (MAGNESIUM) | MAGNESIUM | 25 mg
ZINC OXIDE (ZINC OXIDE) | ZINC OXIDE | 25 mg
SODIUM SELENATE (SELENATE ION) | SODIUM SELENATE | 65 ug
CUPRIC OXIDE (CUPRIC CATION) | CUPRIC CATION | 1.8 mg
IODINE (IODINE) | IODINE | 210 ug
CHOLINE (CHOLINE) | CHOLINE | 55 mg
.BETA.-CAROTENE (.BETA.-CAROTENE) | .BETA.-CAROTENE | 2800 [iU]
ASCORBIC ACID (ASCORBIC ACID) | ASCORBIC ACID | 120 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) | CHOLECALCIFEROL | 640 [iU]
.ALPHA.-TOCOPHEROL ACETATE, D- (.ALPHA.-TOCOPHEROL, D-) | .ALPHA.-TOCOPHEROL, D- | 15 mg
THIAMINE MONONITRATE (THIAMINE ION) | THIAMINE MONONITRATE | 1.5 mg
RIBOFLAVIN (RIBOFLAVIN) | RIBOFLAVIN | 2 mg
NIACINAMIDE (NIACINAMIDE) | NIACINAMIDE | 20 mg

Inactive Ingredients
Ingredient Name | Strength
TITANIUM DIOXIDE |
CELLULOSE, MICROCRYSTALLINE |
TALC |
FD&C RED NO. 40 |
FD&C BLUE NO. 1 |
FD&C BLUE NO. 2 |
STARCH, CORN |
SILICON DIOXIDE |
MAGNESIUM STEARATE |
POLYETHYLENE GLYCOL, UNSPECIFIED |
POLYVINYL ALCOHOL |

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

Packaging
# | Item Code | Package Description
1 | NDC:44118-751-30 | 30 TABLET in 1 BLISTER PACK

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 | DEA Schedule |

Active Ingredient/Active Moiety
Ingredient Name | Basis of Strength | Strength
OMEGA-3 FATTY ACIDS (OMEGA-3 FATTY ACIDS) | OMEGA-3 FATTY ACIDS | 267 mg

Inactive Ingredients
Ingredient Name | Strength
GELATIN |
RICE BRAN OIL |
GLYCERIN |
WATER |

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

Packaging
# | Item Code | Package Description
1 | NDC:44118-752-30 | 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK

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)

Eckson Labs, LLC

## More about DuetDHA Balanced (multivitamin, prenatal)

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