VemaVite-PRx 2

TRIGEN Laboratories, Inc.

VemaVite™-PRx 2 Rx Prenatal Vitamin with Fish-Based DHA

FULL PRESCRIBING INFORMATION: CONTENTS*

• VEMAVITE-PRX 2 DESCRIPTION
• INDICATIONS
• VEMAVITE-PRX 2 CONTRAINDICATIONS
• WARNING
• PRECAUTION
• VEMAVITE-PRX 2 ADVERSE REACTIONS
• CAUTION
• VEMAVITE-PRX 2 DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

• 1.25 mg Folic Acid and 300 mg DHA (key omega-3 fatty acid)
• Essential vitamins and minerals
• Gentle stool softener

VEMAVITE-PRX 2 DESCRIPTION

VemaVite™-PRx 2 is a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish-based DHA. Each softgel capsule is an oblong, maroon softgel capsule imprinted with "T598" in white ink.

Inactive Ingredients: FD&C Blue #1, FD&C Red #40, FD&C Yellow #6, Natural Creamy Orange Flavor, Gelatin, Glycerin, Lecithin, Purified Water, Soybean Oil, Titanium Dioxide, Ethyl Vanillin, Yellow Beeswax.

INDICATIONS

VemaVite™-PRx 2 softgel capsules are indicated to provide vitamin/mineral and fish-based DHA supplementation throughout pregnancy, during the postnatal period for both lactating and non-lactating mothers, and throughout the childbearing years. VemaVite™-PRx 2 may be useful in improving the nutritional status of women prior to conception.

VEMAVITE-PRX 2 CONTRAINDICATIONS

VemaVite™-PRx 2 is contraindicated in patients with a known hypersensitivity to any of the ingredients, including fish or fish oil. Do not take this product if you are presently taking mineral oil, unless directed by a doctor.

THIS PRODUCT CONTAINS FISH OIL AND SOY.

WARNING

Ingestion of more than 3 grams of omega-3 fatty acids (such as DHA) per day has been shown to have potential antithrombotic effects, including an increased bleeding time and International Normalized Ratio (INR). Administration of omega-3 fatty acids should be avoided in patients taking anticoagulants and in those known to have an inherited or acquired predisposition to bleeding.

PRECAUTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B₁₂ is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.

VEMAVITE-PRX 2 ADVERSE REACTIONS

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

CAUTION

Exercise caution to ensure that the prescribed dosage of DHA does not exceed 1 gram (1000 mg) per day.

VEMAVITE-PRX 2 DOSAGE AND ADMINISTRATION

Before, during and/or after pregnancy, one softgel capsule daily or as directed by a physician.

HOW SUPPLIED

Bottles of 30 softgel capsules.

NDC 13811-598-30

KEEP THIS AND ALL DRUGS OUT OF THE REACH OF CHILDREN.

Store at Controlled Room Temperature 20°-25°C (68°-77°F). [See USP].

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 equivalence.

Rx Only

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

MADE IN CANADA

Rev. 10/10

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

NDC 13811-598-30
R_x Only

VemaVite™-PRx 2
Softgel Capsule

30 CAPSULES

TRIGEN
LABORATORIES