Duet DHA
Duet DHA 400
FULL PRESCRIBING INFORMATION: CONTENTS*
- DUET DHA DESCRIPTION:
- INDICATIONS:
- DUET DHA CONTRAINDICATIONS:
- WARNINGS:
- PRECAUTIONS:
- DRUG INTERACTIONS:
- DUET DHA ADVERSE REACTIONS:
- DUET DHA DOSAGE AND ADMINISTRATION:
- HOW SUPPLIED:
- STORAGE:
FULL PRESCRIBING INFORMATION
Rx Only
DESCRIPTION:
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 (d-alpha tocopheryl acetate) | 3 mg |
| Vitamin B1 (thiamine mononitrate) | 1.8 mg |
| Vitamin B2 (riboflavin) | 4 mg |
| Niacinamide | 20 mg |
| Vitamin B6 (pyridoxine hydrochloride) | 50 mg |
| Folic acid | 1 mg |
| Vitamin B12 (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 |
| Iodine | 220 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, surelease dispersion, d-alpha tocopherol, ethyl vanillin
INDICATIONS:
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:
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 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:
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 44118-807-30, 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:
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
Duet DHA.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 KIT
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