Triveen-Duo DHA

TRIGEN Laboratories, Inc.

Triveen™-Duo DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• TRIVEEN-DUO DHA DESCRIPTION
• INDICATION
• TRIVEEN-DUO DHA CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• DRUG INTERACTIONS
• TRIVEEN-DUO DHA ADVERSE REACTIONS
• Inactive Ingredients
• TRIVEEN-DUO DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - Kit Carton

FULL PRESCRIBING INFORMATION

TRIVEEN-DUO DHA DESCRIPTION

Triveen™-Duo DHA is a prescription regimen of prenatal multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as tablets and softgel capsules. The Triveen™-Duo DHA tablet is a yellow, oval tablet debossed with "T591" on one side. The DHA softgel capsule is a clear, oblong softgel capsule containing pale yellow oil.

INDICATION

Triveen™-Duo 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. Triveen™-Duo DHA is also useful in improving nutritional status prior to conception.

The daily regimen of Triveen™-Duo DHA contains:

• (1)Triveen™-Duo DHA prenatal vitamin tablet plus
• (1)Softgel capsule containing at least 275mg of DHA.
• •400mg of omega-3 fatty acids.
• •15 vitamins and minerals - including 1mg folic acid.
• •25mg of vitamin B₆.

As with any prescription strength product containing folic acid, omega-fatty acids, iron or the non-water soluble Vitamin D and E, adhere carefully to the dosages prescribed by your physician.

TRIVEEN-DUO DHA CONTRAINDICATIONS

This product is contraindicated in patients with known hypersensitivity to any of the ingredients includingfish 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.

This product contains fish oil.

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.

TRIVEEN-DUO DHA ADVERSE REACTIONS

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Inactive Ingredients

Triveen™-Duo DHA Tablet: Microcrystalline Cellulose, Croscarmellose Sodium, TriPotassium Citrate, Hypromellose, Citric Acid, Acacia, Titanium Dioxide, Povidone K30, Fumed Silica, Magnesium Stearate, Stearic Acid, Polyethylene Glycol, Ethyl Cellulose, Talc, Polysorbate 80, FD&C Yellow #5 Lake, Vegetable Oil, Hydroxypropyl Cellulose, FD&C #6 Yellow Lake.

Triveen™-Duo DHA Softgel: Gelatin, Glycerin, Purified Water and Vitamin E.

TRIVEEN-DUO DHA DOSAGE AND ADMINISTRATION

Before, during and after pregnancy, one tablet and one softgel 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 excercised to ensure that the prescribed dose of DHA does not exceed 1 gram (1,000 mg) per day.

HOW SUPPLIED

Triveen™-Duo DHA is supplied in child-resistant unit-dose blister cards containing 6 Triveen™-Duo DHA tablets and 6 DHA softgel capsules per card. Each unit-of-use dispensing carton contains 5 unit-dose blister cards which is a 30-day supply.

PRODUCT CODE: 13811-591-30

R_x Only

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Protect from moisture and excessive heat. Note that contact with moisture may produce surface discolorations of the tablet.

KEEP OUT OF REACH OF CHILDREN.

Call your doctor about side effects. You may report side effects by calling 888-9-TRIGEN (888-987-4436).

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalences.

See package insert for prescribing and product information.

Manufactured for:
TRIGEN Laboratories, Inc., Sayerville, NJ 08872
www.trigenlab.com

Rev. 02/13

PRINCIPAL DISPLAY PANEL - Kit Carton

13811-591-30
R_x Only

Triveen™-Duo DHA

WITH DHA, AN OMEGA-3 FATTY ACID

DESCRIPTION: Triveen™-Duo DHA is a prescription regimen of prenatal
multi-vitamin, multi-mineral, and omega-3 fatty acid supplements, supplied as
tablets and softgel capsules. The Triveen™-Duo DHA tablet is a yellow, oval tablet
debossed with "T591" on one side. The DHA softgel capsule is a clear, oblong
softgel capsule containing pale yellow oil.

INDICATION: Triveen™-Duo 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. Triveen™-Duo DHA
is also useful in improving nutritional status prior to conception.

The daily regimen of Triveen™-Duo DHA contains:

• (1)Triveen™-Duo DHA prenatal vitamin tablet plus
• (1)Softgel capsule containing at least 275mg of DHA.
• •400mg of omega-3 fatty acids.
• •15 vitamins and minerals - including 1mg folic acid.
• •25mg of vitamin B₆.

30 Day Supply
30 tablets and 30 softgel capsules

TRIGEN
LABORATORIES