DUET®DHAec by StuartNatal®
(Rx Only)
DESCRIPTION: Duet®DHAec is a prescription regimen of prenatal
multi-vitamin, multi-mineral, and omega-3 fatty acid supplements,
supplied as tablets and enteric-coated softgel capsules.
Each yellow oval Duet® Tablet* contains:
VITAMINS
- A (beta carotene) 3,000 IU
- C (ascorbic acid) 120 mg
- D (cholecalciferol) 400 IU
- E (dl-alpha tocopheryl acetate) 3 mg
- B1 (thiamine mononitrate) 1.8 mg
- B2 (riboflavin) 4 mg
- Niacinamide 20 mg
- B6 (pyridoxine hydrochloride) 25 mg
- Folic acid 1 mg
- B12 (cyanocobalamin) 12 mcg
MINERALS
- Calcium (calcium carbonate) 200 mg
- Iron (ferrous bisglycinate HCl and IronAid®1) 29 mg
- Magnesium (magnesium oxide) 25 mg
- Zinc (zinc oxide) 25 mg
- Copper (cupric oxide) 2 mg
Each frosted golden-colored oval enteric-coated DHA softgel
capsule* contains:
- 430 mg purified omega-3 fatty acids including:
At least 295 mg DHA (docosahexaenoic acid); also contains
EPA (eicosapentaenoic acid) and other omega-3 fatty acids.
OTHER INGREDIENTS (Duet® Tablet): Acacia, ascorbyl palmitate,
butylated hydroxytoluene, casein, cornstarch, croscarmellose sodium,
dicalcium phosphate, dl-alpha tocopherol, gelatin, hypromellose,
magnesium stearate, microcrystalline cellulose, mixed glycerides,
polyethylene glycol, polysorbate 80, silicon dioxide, sodium
aluminum silicate, sodium ascorbate, sodium benzoate, sorbic acid,
sucrose, titanium dioxide.
OTHER INGREDIENTS (Enteric-coated DHA softgel capsule):
Ammonium hydroxide, ethylcellulose, fractionated coconut oil,
gelatin, glycerin, oleic acid, stearic acid, sodium alginate and DHA
and EPA concentrate derived from purified fish oil via a proprietary
process.
*USP Compliance: Duet® Tablet is formulated in conformance with
official U.S. Pharmacopeia (USP) standards of quality for potency,
purity and dissolution. The enteric-coated DHA softgel capsule
complies with the standards and methods outlined in the CRN
Voluntary Monograph for potency and purity.
INDICATIONS: Duet®DHAec is a 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. Duet®DHAec is also useful in improving
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.
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 a poison control center immediately.
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.
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 enteric-coated softgel capsule taken
by mouth daily, or as directed by a physician. The tablet and entericcoated
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 1gram (1,000 mg) per day.
HOW SUPPLIED: NDC 66479-870-30. Duet®DHAec is supplied
in child-resistant blister cards containing 30 doses per carton (1
Duet® tablet and 1 enteric-coated DHA softgel capsule equals 1
daily dose). Each unit-of-use dispensing carton contains 5 cards
with 6 unit-doses per card which is a 30-day supply. Duet® is a
yellow oval tablet imprinted with the StuartNatal® logo (“heart-ina-
heart”) on one side and “858” on the other. The frosted goldencolored
oval enteric-coated DHA softgel capsule is imprinted with
the StuartNatal® logo (“heart-in-a-heart” outlined traced) on one side
and X1 on the other.
STORAGE: Store at controlled room temperature 20-25˚C (68-
77˚F). Protect from moisture and excessive heat. Note that contact
with moisture may produce surface discoloration of the tablet.
DISPENSING: Keep in a well-closed, light-resistant container as
defined by the USP. Unit dose blisters are child-resistant to opening
as a safeguard against ingestion by children. KEEP THIS AND ALL
MEDICATIONS OUT OF THE REACH OF CHILDREN.
Questions or Comments:
1-877-926-6396
www.DuetDHA.com
Marketed by: Xanodyne Pharmaceuticals, Inc.
Newport, KY 41071 USA
StuartNatal, Duet and the “heart-in-a-heart” logo are registered trademarks of Xanodyne Pharmaceuticals, Inc. Patents pending. All rights reserved.
1.IronAid is a registered trademark of Chemi Nutra.
© 2008, Xanodyne® Pharmaceuticals, Inc.
PI-870-A Revision 07/08 |
