Taron-Prex

TRIGEN Laboratories, Inc.

Taron™-Prex Prenatal with DHA CAP

FULL PRESCRIBING INFORMATION: CONTENTS*

• TARON-PREX DESCRIPTION
• INDICATIONS
• TARON-PREX CONTRAINDICATIONS
• WARNING
• PRECAUTION
• TARON-PREX ADVERSE REACTIONS
• CAUTION
• RECOMMENDED USE
• HOW SUPPLIED
  • STORAGE
• PRINCIPAL DISPLAY PANEL - 30 Capsule Label

FULL PRESCRIBING INFORMATION

R_x Only

TARON-PREX DESCRIPTION

Taron™-Prex Prenatal with DHA capsules are a prescription prenatal/postnatal multivitamin/mineral softgel capsule with fish oil-based DHA. Each softgel capsule is oblong, maroon and imprinted with "T543"

• 1.25 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid from purified fish oil)
• Essential vitamins and minerals

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

INDICATIONS

Taron™-Prex Prenatal with DHA 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. Taron™-Prex Prenatal with DHA may be useful in improving the nutritional status of women prior to conception.

TARON-PREX CONTRAINDICATIONS

Taron™-Prex Prenatal with DHA capsules are 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.

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.

THIS PRODUCT CONTAINS SOY AND FISH OIL.

PRECAUTION

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias here 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.

TARON-PREX 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.

RECOMMENDED USE

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

HOW SUPPLIED

Taron™-Prex Prenatal with DHA capsules are available in bottles of 30 softgel capsules.

Product Code: 13811-543-30

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°- 86°F) [See USP controlled room temperature].

KEEP THIS AND ALL DRUGS OUT OF THE 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 statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Rx 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 equivalence.

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

Rev. 07/13

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

13811-543-30

R_x Only

Taron™-Prex Prenatal
with DHA CAP

R_X PRENATAL VITAMIN

• 1.2 mg Folic Acid and 265 mg DHA
  (key omega-3 fatty acid)
• Essential vitamins and minerals

30 CAPSULES

TRIGEN
LABORATORIES