TARON-PREX PRENATAL: Package Insert and Label Information

TARON-PREX PRENATAL- ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, .alpha.-tocopherol, d-, pyridoxine hydrochloride, folic acid, doconexent and docusate sodium capsule
Trigen Laboratories, LLC

SUPPLEMENT FACTS

Taron-Prex Prenatal with DHA Supplement Facts Panel Rev. 06/2019
(click image for full-size original)

Other Ingredients: Gelatin (Bovine), Glycerin, Soy Lecithin, Purified Water, Yellow Beeswax, Natural and Artificial Orange Cream Flavor, Sorbitol, Soybean Oil, FD&C Red #40, Titanium Dioxide, Ethyl Vanillin, FD&C Yellow #6, and FD&C Blue #1

THIS PRODUCT CONTAINS SOY AND FISH OIL (ANCHOVY).

Taron™-Prex Prenatal with DHA capsules is a prescription multivitamin/mineral indicated to provide 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 soy or fish products. Do not take this product if you are currently taking mineral oil, unless directed by a doctor.

WARNINGS

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 REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTIONS

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.

The patient’s medical conditions and consumption of other drugs, herbs, and/or supplements should be considered.

DRUG INTERACTIONS

Taron™-Prex Prenatal with DHA capsules is not recommended for and should not be given to patients receiving levodopa because the action of levodopa is antagonized by pyridoxine. There is a possibility of increased bleeding due to pyridoxine interaction with anticoagulants (e.g., Aspirin, Heparin, Clopidogrel).

ADVERSE REACTIONS

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

DESCRIPTION

Taron™-Prex Prenatal with DHA is a maroon, oblong softgel capsule imprinted with “T543”.

DIRECTIONS FOR USE

Take one softgel capsule by mouth daily or as prescribed by a physician.

HOW SUPPLIED

Taron™-Prex Prenatal with DHA is dispensed 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 OUT OF REACH OF CHILDREN.


For use on the order of a healthcare practitioner.


Call your doctor about side effects. To report side effects, call Trigen Laboratories, LLC at 1-877-482-3788 or FDA at 1-800-FDA-1088.


Rev. 09/2019

Customer Service: 1-877-482-3788 Rev072018


Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807
www.trigenlab.com

PRINCIPAL DISPLAY PANEL

13811-543-30

Taron™-Prex Prenatal
with DHA CAP

30 CAPSULES

TRIGEN LABORATORIES

Taron Prex Prenatal Bottle label
(click image for full-size original)
Taron Prex Prenatal Bottle label
(click image for full-size original)

TARON-PREX PRENATAL ascorbic acid, tribasic calcium phosphate, ferrous fumarate, cholecalciferol, d-alpha tocopherol, pyridoxine hydrochloride, folic acid, docosahexaenoic acid, and docusate sodium capsule
Product Information
Product Type 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) CALCIUM CATION 160 mg
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 30 mg
CHOLECALCIFEROL (CHOLECALCIFEROL) CHOLECALCIFEROL 170 [iU]
.ALPHA.-TOCOPHEROL, D- (.ALPHA.-TOCOPHEROL, D-) .ALPHA.-TOCOPHEROL, D- 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
GLYCERIN
LECITHIN, SOYBEAN
WATER
YELLOW WAX
SORBITOL
SOYBEAN OIL
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 Size 20mm
Flavor ORANGE Imprint Code T543
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13811-543-30 30 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 12/01/2009
Labeler — Trigen Laboratories, LLC (830479668)

Revised: 06/2020 Trigen Laboratories, LLC

DrugInserts.com provides trustworthy package insert and label information about marketed drugs as submitted by manufacturers to the US Food and Drug Administration. Package information is not reviewed or updated separately by DrugInserts.com. Every individual package label entry contains a unique identifier which can be used to secure further details directly from the US National Institutes of Health and/or the FDA.

As the leading independent provider of trustworthy medication information, we source our database directly from the FDA's central repository of drug labels and package inserts under the Structured Product Labeling standard. Our material is not intended as a substitute for direct consultation with a qualified health professional.

Terms of Use | Copyright © 2020. All Rights Reserved.