NDC | 13811-543-30 |
Set ID | f298af01-aae7-45d8-b2ea-db9139d858fc |
Category | DIETARY SUPPLEMENT |
Packager | Trigen Laboratories, LLC |
Generic Name | |
Product Class | |
Product Number | |
Application Number |
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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.
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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.
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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
- DESCRIPTION
- DIRECTIONS FOR USE
- HOW SUPPLIED
- STORAGE
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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. 09/2019Customer Service: 1-877-482-3788
Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807
www.trigenlab.com - PRINCIPAL DISPLAY PANEL
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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 capsuleProduct 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)