TRIPHROCAPS- folic acid, ascorbic acid, niacinamide, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, and biotin capsule

TriphroCaps by

Drug Labeling and Warnings

TriphroCaps 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: Soybean Oil, Bovine Gelatin, Glycerin, Water, Yellow Beeswax, Lecithin, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Yellow #5, FD&C Yellow #6, and Iron Oxide Red 

THIS PRODUCT CONTAINS SOY. 

 TriphroCaps are an orally administered prescription vitamin used for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation.

CONTRAINDICATIONS

TriphroCaps are contraindicated in patients with a known hypersensitivity to any of the ingredients including soy.

PRECAUTIONS

Folic acid alone is an improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where 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.

Pediatric Use: Safety and effectiveness in pediatric patients have not been established.

Geriatric Use: Safety and effectiveness in elderly patients have not been established.

Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including cardiovascular diagnostic tests (e.g. troponin) and hormone tests, and may lead to incorrect test results. Tell your healthcare provider about all prescription and over-the-counter medicines, vitamins, and dietary supplements that you take, including biotin.

This product contains FD&C Yellow No. 5 (tartrazine) which may cause allergic-type reactions (including bronchial asthma) in certain susceptible patients. Although the overall incidence of FD&C Yellow No. 5 (tartrazine) sensitivity in the general population is low, it is frequently seen in patients who also have aspirin hypersensitivity.

DRUG INTERACTIONS

TriphroCaps 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

TriphroCaps are red, oval softgel capsules, imprinted with "T9".

DIRECTIONS FOR USE

Take one softgel capsule daily or as prescribed by a physician. On dialysis days, take one TriphroCaps softgel after dialysis.

HOW SUPPLIED

TriphroCaps are supplied in bottles of 100 softgel capsules.

Product Code: 13811-525-01

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

 

PRINCIPAL DISPLAY PANEL - 100 Softgel Bottle Label

13811-525-01

TriphroCaps
Softgels

100 SOFTGELS

TRIGEN
LABORATORIES

INGREDIENTS AND APPEARANCE

TRIPHROCAPS 
folic acid, ascorbic acid, niacinamide, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, and biotin capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-525
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
folic acid (UNII: 935E97BOY8) (folic acid - UNII:935E97BOY8)	folic acid	1 mg
ascorbic acid (UNII: PQ6CK8PD0R) (ascorbic acid - UNII:PQ6CK8PD0R)	ascorbic acid	100 mg
niacinamide (UNII: 25X51I8RD4) (niacinamide - UNII:25X51I8RD4)	niacinamide	20 mg
thiamine mononitrate (UNII: 8K0I04919X) (THIAMINE ION - UNII:4ABT0J945J)	Thiamine	1.5 mg
riboflavin (UNII: TLM2976OFR) (riboflavin - UNII:TLM2976OFR)	riboflavin	1.7 mg
pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (PYRIDOXINE - UNII:KV2JZ1BI6Z)	pyridoxine Hydrochloride	10 mg
cyanocobalamin (UNII: P6YC3EG204) (cyanocobalamin - UNII:P6YC3EG204)	cyanocobalamin	6 ug
calcium pantothenate (UNII: 568ET80C3D) (PANTOTHENIC ACID - UNII:19F5HK2737, CALCIUM CATION - UNII:2M83C4R6ZB)	PANTOTHENIC ACID	5 mg
biotin (UNII: 6SO6U10H04) (biotin - UNII:6SO6U10H04)	biotin	150 ug

Inactive Ingredients
Ingredient Name	Strength
soybean oil (UNII: 241ATL177A)
GELATIN TYPE B BOVINE (160 BLOOM) (UNII: 1T8387508X)
glycerin (UNII: PDC6A3C0OX)
water (UNII: 059QF0KO0R)
yellow wax (UNII: 2ZA36H0S2V)
titanium dioxide (UNII: 15FIX9V2JP)
FD&C Red No. 40 (UNII: WZB9127XOA)
ethyl vanillin (UNII: YC9ST449YJ)
FD&C yellow No. 5 (UNII: I753WB2F1M)
FD&C yellow No. 6 (UNII: H77VEI93A8)
ferric oxide red (UNII: 1K09F3G675)
LECITHIN, SOYBEAN (UNII: 1DI56QDM62)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-525-01	100 in 1 BOTTLE

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		01/27/2016

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	13 mm

Labeler - Trigen Laboratories, LLC (830479668)