Taron-Prex Prenatal

Dosage Form: capsule
Taron™-Prex Prenatal with DHA CAP

Rx Prenatal Vitamin

Rx Only

Taron-Prex Prenatal 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" in white ink.

• 1.2 mg Folic Acid and 265 mg DHA (key omega-3 fatty acid from purified fish oil)


• Essential vitamins and minerals


• Gentle stool softener

Each softgel capsule contains:
* From approximately 350 mg of Omegas derived from approximately 380 mg of purified fish oil.
Vitamin C (ascorbic acid, USP)	25 mg
Calcium (tribasic calcium phosphate, NF)	160 mg
Iron (ferrous fumarate, USP)	30 mg
Vitamin D3 (cholecalciferol, USP)	170 IU
Vitamin E (d-alpha tocopherol, USP)	30 IU
Vitamin B6 (pyridoxine hydrochloride, USP)	25 mg
Folic Acid, USP	1.2 mg
DHA (Docosahexaenoic Acid)	265 mg*
Docusate Sodium, USP	not more than 55 mg

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, 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.

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.

WARNING

Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF THE REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

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.

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.

Taron-Prex Prenatal Dosage and Administration

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

How is Taron-Prex Prenatal Supplied

Bottles of 30 softgel capsules

NDC 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).

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. 06/11

PRINCIPAL DISPLAY PANEL - 30 Capsule Label

NDC 13811-543-30

Rx Only

Taron™-Prex Prenatal

with DHA CAP

RX PRENATAL VITAMIN

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


• Essential vitamins and minerals


• Gentle stool softener

30 CAPSULES

TRIGEN

LABORATORIES

TARON-PREX  PRENATAL ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent, and docusate sodium  capsule

Product Information Product Type HUMAN PRESCRIPTION DRUG NDC Product Code (Source) 13811-543 Route of Administration ORAL DEA Schedule

Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength Ascorbic Acid (Ascorbic Acid) Ascorbic Acid 25 mg Tribasic Calcium Phosphate (Calcium Cation) Tribasic Calcium Phosphate 160 mg Iron (Iron) Iron 30 mg Cholecalciferol (Cholecalciferol) Cholecalciferol 170 [iU] Alpha-Tocopherol (Alpha-Tocopherol) Alpha-Tocopherol 30 [iU] Pyridoxine Hydrochloride (Pyridoxine) Pyridoxine Hydrochloride 25 mg Folic Acid (Folic Acid) Folic Acid 1.2 mg Doconexent (Doconexent) Doconexent 265 mg Docusate Sodium (Docusate) Docusate Sodium 55 mg

Inactive Ingredients Ingredient Name Strength Gelatin   Soybean Oil   Glycerin   Water   Yellow Wax   FD&C Red No. 40   Titanium Dioxide   Ethyl Vanillin   FD&C Yellow No. 6   FD&C Blue No. 1

Product Characteristics Color RED (maroon) Score no score Shape CAPSULE (oblong) Size 20mm Flavor ORANGE Imprint Code T543 Contains

Packaging # NDC Package Description Multilevel Packaging 1 13811-543-30 30 CAPSULE In 1 BOTTLE None

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Unapproved drug other		12/01/2009

Labeler - TRIGEN Laboratories, Inc. (830479668)

Revised: 09/2011TRIGEN Laboratories, Inc.