Search by Drug Name or NDC
NDC 44118-0750-05 Duet DHA Balanced Details
Duet DHA Balanced
Duet DHA Balanced is a KIT in the HUMAN PRESCRIPTION DRUG category. It is labeled and distributed by Eckson Labs, LLC. The primary component is .
Product Information
| NDC | 44118-0750 |
|---|---|
| Product ID | 44118-750_9a9ec604-5432-635e-e053-2995a90a78d6 |
| Associated GPIs | 78512097006316 |
| GCN Sequence Number | 071284 |
| GCN Sequence Number Description | PNV 117/iron/folic/om3/dha/epa COMBO. PKG 25 MG-1 MG ORAL |
| HIC3 | C6F |
| HIC3 Description | PRENATAL VITAMIN PREPARATIONS |
| GCN | 35028 |
| HICL Sequence Number | 040515 |
| HICL Sequence Number Description | PRENATAL VITS NO.117/SOD FEREDET.-IRON PS/FOLIC/OM3/DHA/EPA |
| Brand/Generic | Brand |
| Proprietary Name | Duet DHA Balanced |
| Proprietary Name Suffix | n/a |
| Non-Proprietary Name | .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, IO |
| Product Type | HUMAN PRESCRIPTION DRUG |
| Dosage Form | KIT |
| Route | n/a |
| Active Ingredient Strength | n/a |
| Active Ingredient Units | n/a |
| Substance Name | n/a |
| Labeler Name | Eckson Labs, LLC |
| Pharmaceutical Class | n/a |
| DEA Schedule | n/a |
| Marketing Category | UNAPPROVED DRUG OTHER |
| Application Number | n/a |
| Listing Certified Through | 2022-12-31 |
Package
Package Images
NDC 44118-0750-05 (44118075005)
| NDC Package Code | 44118-750-05 |
|---|---|
| Billing NDC | 44118075005 |
| Package | 1 KIT in 1 CARTON (44118-750-05) * 30 TABLET in 1 BLISTER PACK (44118-751-30) * 30 CAPSULE, GELATIN COATED in 1 BLISTER PACK (44118-752-30) |
| Marketing Start Date | 2012-10-30 |
| NDC Exclude Flag | N |
| Pricing Information | N/A |
Standard Product Labeling (SPL)/Prescribing Information SPL f7445e81-8ae7-47fb-81c0-6b14837edbe4 Details
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:
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:
DRUG INTERACTIONS:
ADVERSE REACTIONS:
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:
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
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 |
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|
||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| Labeler - Eckson Labs, LLC (078435242) |