Taron-Prex Prenatal

Generic Name: ascorbic acid, tribasic calcium phosphate, iron, cholecalciferol, alpha-tocopherol, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium
Dosage Form: capsule

Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.

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 LABEL Item Code (Source) NDC: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
# Item Code Package Description
1 NDC:13811-543-30 30 CAPSULE (CAPSULE) in 1 BOTTLE
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: 09/2011
 
TRIGEN Laboratories, Inc.
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