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

TARON-PREX by

Drug Labeling and Warnings

TARON-PREX by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

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].

HEALTH CLAIM

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. 06/2019

 Customer Service: 1-877-482-3788                                                                                                                           

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

INGREDIENTS AND APPEARANCE

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	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-543
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R)	ASCORBIC ACID	25 mg
TRIBASIC CALCIUM PHOSPHATE (UNII: 91D9GV0Z28) (CALCIUM CATION - UNII:2M83C4R6ZB)	CALCIUM CATION	160 mg
FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR)	FERROUS CATION	30 mg
CHOLECALCIFEROL (UNII: 1C6V77QF41) (CHOLECALCIFEROL - UNII:1C6V77QF41)	CHOLECALCIFEROL	170 [iU]
.ALPHA.-TOCOPHEROL, D- (UNII: N9PR3490H9) (.ALPHA.-TOCOPHEROL, D- - UNII:N9PR3490H9)	.ALPHA.-TOCOPHEROL, D-	30 [iU]
PYRIDOXINE HYDROCHLORIDE (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	PYRIDOXINE HYDROCHLORIDE	25 mg
FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8)	FOLIC ACID	1.2 mg
DOCONEXENT (UNII: ZAD9OKH9JC) (DOCONEXENT - UNII:ZAD9OKH9JC)	DOCONEXENT	265 mg
DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG)	DOCUSATE SODIUM	55 mg

Inactive Ingredients
Ingredient Name	Strength
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 Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-543-30	30 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		12/01/2009

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
flavor
imprint
scoring	1
shape
size (solid drugs)	20 mm

Labeler - Trigen Laboratories, LLC (830479668)