DUET®DHA with Ferrazone®
and enteric-coated omega-3 fatty acid
(Duet®DHA)
by StuartNatal®
(Rx Only)
DESCRIPTION: Duet®DHA with Ferrazone® and enteric-coated omega-3 is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acids, supplied as tablets and enteric-coated softgel capsules.
Each yellow oval Duet® Tablet* with Ferrazone® contains:
VITAMINS
- A (beta carotene) 3,000 IU
- C (ascorbic acid) 130 mg
- D (cholecalciferol) 410 IU
- E (dl-alpha tocopheryl acetate) 30 mg
- B1 (thiamine mononitrate) 1.8 mg
- B2 (riboflavin) 4 mg
- Niacinamide 20 mg
- B6 (pyridoxine hydrochloride) 28 mg
- Folic acid 1 mg
- B12 (cyanocobalamin) 12 mcg
MINERALS
- Calcium (calcium carbonate) 230 mg
- Iron (soldioum EDTA, Ferrazone®) 30 mg
- Magnesium (magnesium oxide) 25 mg
- Zinc (zinc oxide) 26 mg
- Copper (cupric oxide) 2 mg
Each frosted golden-colored oval enteric-coated DHA Softgel
Capsule* contains: A clear solution with 440 mg purified omega-3 long-chain fatty acids including: DHA (docosahexaenoic acid);
EPA (eicosapentaenoic acid) and DPA (docasapentaenoic acid) in 628mg of fish oil.
OMEGA-3 FATTY ACIDS
- Total omega-3 long chain fatty acids 440 mg
- As DHA 295 mg
- As other omega-3 long-chain fatty acid 145 mg
OTHER INGREDIENTS (Duet® Tablet): Acacia, ascorbyl palmitate,
butylated hydroxytoluene, cornstarch, croscarmellose sodium,
dicalcium phosphate, dl-alpha tocopherol, gelatin, hypromellose,
magnesium stearate, microcrystalline cellulose, mixed glycerides,
polyethylene glycol, polysorbate 80, sodium
aluminum siliciate, sodium ascorbate,
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: The yellow oval Duet® Tablet is formulated in conformance with official U.S. Pharmacopeia (USP) standards of quality for potency,
purity and dissolution. Duet® Tablet, as manufactured, is subject to Quality Control Standards and Good Manufacturing Practices established by U.S. FDA. The enteric-coated DHA softgel capsule complies with the standards and methods outlined in the CRN Voluntary Monograph for potency and purity.
INDICATIONS: Duet®DHA 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®DHA 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 enteric-coated
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: NDC 66479-880-30. Duet®DHA 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. The yellow oval Duet® tablet is imprinted with the StuartNatal® logo (“heart-in-a-
heart”) on one side and “878” on the other. The frosted golden-colored
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.
To request medical information or to report suspected adverse reactions contact Xanodyne Medical Affairs at 1-877-773-7793.
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.
Ferrazone® is a registered trademark of AkzoNobel b v
© 2009, Xanodyne® Pharmaceuticals, Inc.
PI-880-A Revision 04/2009 LC-10855 |
