DUET^®DHA^ec by StuartNatal^®
(Rx Only)

DESCRIPTION: Duet^®DHA^ec 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) 430 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: DuetDHA^ec 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. DuetDHA^ec 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 entericcoated 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 66479-861-30. DuetDHA^ec is supplied in child-resistant, unit-dose blister cards containing 6 Duet^® tablets and 6 enteric-coated DHA softgel capsules per card. Each unit-of-use dispensing carton contains 5 unit-dose cards which is a 30-day supply. Duet^® is a yellow oval tablet imprinted with the StuartNatal^® logo (“heart-in-a-heart”) on one side and “858” 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).

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.
© 2007, Xanodyne™ Pharmaceuticals, Inc.
PI-861-A Revision 08/07