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

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Taron™-Prex Prenatal
with DHA CAP

SUPPLEMENT FACTS

Taron-Prex Prenatal with DHA Supplement Facts Panel Rev. 06/2019

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 labelTaron Prex Prenatal Bottle label

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 TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:13811-543
Route of AdministrationORAL
Active Ingredient/Active Moiety
Ingredient NameBasis of StrengthStrength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID25 mg
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB) CALCIUM CATION160 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION30 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41) CHOLECALCIFEROL170 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9) .ALPHA.-TOCOPHEROL, D-30 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z) PYRIDOXINE HYDROCHLORIDE25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1.2 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC) DOCONEXENT265 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM55 mg
Inactive Ingredients
Ingredient NameStrength
GELATIN (UNII: 2G86QN327L)  
GLYCERIN (UNII: PDC6A3C0OX)  
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)  
WATER (UNII: 059QF0KO0R)  
YELLOW WAX (UNII: 2ZA36H0S2V)  
SORBITOL (UNII: 506T60A25R)  
SOYBEAN OIL (UNII: 241ATL177A)  
FD&C RED NO. 40 (UNII: WZB9127XOA)  
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
ETHYL VANILLIN (UNII: YC9ST449YJ)  
FD&C YELLOW NO. 6 (UNII: H77VEI93A8)  
FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
Packaging
#Item CodePackage DescriptionMarketing Start DateMarketing End Date
1NHRIC:13811-543-3030 in 1 BOTTLE
Marketing Information
Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
DIETARY SUPPLEMENT12/01/200907/31/2022
Supplement Facts
Serving Size : Serving per Container :
Amount Per Serving% Daily Value
color
flavor
imprint
scoring1
shape
size (solid drugs)20 mm
Labeler - Trigen Laboratories, LLC (830479668)

Revised: 6/2020
 
Trigen Laboratories, LLC