Vena-Bal DHA

TRIGEN Laboratories, Inc.

Vena-Bal DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• VENA-BAL DHA DESCRIPTION
• INDICATIONS
• VENA-BAL DHA CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
• DRUG INTERACTIONS
• VENA-BAL DHA ADVERSE REACTIONS
• VENA-BAL DHA DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - Kit Carton

FULL PRESCRIBING INFORMATION

VENA-BAL DHA DESCRIPTION

Vena-Bal DHA is a gluten free prescription regimen of prenatal multivitamin, multimineral, and omega-3 fatty acids, supplied as tablets and enteric coated softgel capsules. The Vena-Bal DHA tablet is a yellow, oval tablet debossed "TL601". The enteric-coated DHA softgel capsule is a clear, oblong softgel capsule containing pale yellow oil.

Inactive Ingredients(Vena-Bal DHA Tablet): Microcrystalline Cellulose, Hypromellose, TriPotassium Citrate, Croscarmellose Sodium, Titanium Dioxide, Acacia, Citric Acid, Povidone K30, Stearic Acid, Magnesium Stearate, Polyethylene Glycol, Ethyl Cellulose, Talc, Fumed Silica, Polysorbate 80, FD&C Yellow #5 Lake, Mineral Oil, Hydroxypropyl Cellulose, Ascorbyl Palmitate, FD&C Yellow #6 Lake.

Each oblong, Enteric-coated DHA Softgel Capsule contains: Not less than 430 mg purified omega-3 long-chain fatty acids including DHA (docosahexaenoic acid), EPA (eicosapentaenoic acid), and DPA (docasapentaenoic acid) in approximately 628 mg of fish oil.

Inactive Ingredients (Enteric-coated DHA Softgel Capsule): Gelatin, Glycerin, Purified Water, Enteric Coating (Dewaxed Shellac USP, Sodium Aliginate, Ammonium Hydroxide, Glycerin, Acetylated Monoglycerides, Polysorbate 80, Potassium Sorbate, and Carnauba Wax)

INDICATIONS

Vena-Bal DHA is a gluten free prescription regimen of prenatal multivitamin, multimineral, 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. Vena-Bal DHA is also useful in improving the nutritional status prior to conception.

VENA-BAL DHA 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.

THIS PRODUCT CONTAINS FISH OIL.

Since daily ingestion of more than 3 grams per day of omega-3 fatty acids [including alpha-linolenic acid (ALA), 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.

VENA-BAL DHA ADVERSE REACTIONS

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

VENA-BAL DHA DOSAGE AND ADMINISTRATION

Before, during and after pregnancy, One tablet and One enteric-coated softgel capsule taken by mouth daily, or as prescribed 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

Vena-Bal DHA is supplied in child-resistant blister cards containing 30 doses per carton (1 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.

PRODUCT CODE: 13811-601-30

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 discoloration of the tablet. Keep in a well-closed, light-resistant container as defined by the USP.

KEEP THIS PRODUCT OUT OF REACH OF CHILDREN.

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

R_x Only

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.

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

Rev. 04/13

PRINCIPAL DISPLAY PANEL - Kit Carton

13811-601-30
R_x Only

Vena-Bal DHA

Gluten-Free Prenatal

Multivitamin/Multimineral

TRIGEN
LABORATORIES