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

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TriphroCaps
Softgels

Rx Only

DESCRIPTION

TriphroCaps are an orally administered prescription vitamin for the dietary management of patients with nutritional deficiencies or are in need of nutritional supplementation. TriphroCaps are red, oval softgel capsules, imprinted "T9."

Supplement Facts
Servings per Bottle: 100
Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains
%DV Adults & Children
4 Years or More
Folate 1 mg 250%
Vitamin C (ascorbic acid) 100 mg 167%
Niacin (niacinamide) 20 mg 100%
Thiamine (thiamine mononitrate) 1.5 mg 100%
Riboflavin 1.7 mg 100%
Vitamin B6 (pyridoxine HCl) 10 mg 500%
Vitamin B12 (cyanocobalamin) 6 mcg 100%
Pantothenic Acid (calcium pantothenate) 5 mg 50%
Biotin 150 mcg 50%

Inactive Ingredients: Soybean Oil, Gelatin, Glycerin, Purified Water, Yellow Bees Wax, Lecithin, Titanium Dioxide, FD&C Red #40, Ethyl Vanillin, FD&C Yellow #5, FD&C Yellow #6, Iron Oxide.

INDICATIONS AND USAGE

TriphroCaps are indicated for the supplemental requirements of patients with nutritional deficiencies or are in need of nutritional supplementation.

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

CONTRAINDICATIONS

TriphroCaps is contraindicated in patients with a known hypersensitivity to any of the ingredients.

WARNINGS

Folic acid alone is 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.

THIS PRODUCT CONTAINS SOY.

PRECAUTIONS

Pediatric Use

Safety and effectiveness in pediatric patients have not been established.

Geriatric Use

Clinical studies on this product have not been performed in sufficient numbers of subjects aged 65 and over to determine whether elderly subjects respond differently from younger subjects. In general, dose selection for elderly patients should be cautious, usually starting at the low end of the dosing range, reflecting the greater frequency of decreased hepatic, renal, or cardiac function of concomitant disease or other drug therapy.

ADVERSE REACTIONS

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

DOSAGE AND ADMINISTRATION

Take one TriphroCaps softgel 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].

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

KEEP OUT OF REACH OF CHILDREN

Rx Only

All prescriptions using this product shall be pursuant to state statutes as applicable. This is not an Orange Book product. There are no implied or explicit claims on therapeutic equivalence.

Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.com

Rev. 03/13

PRINCIPAL DISPLAY PANEL - 100 Softgel Bottle Label

13811-525-01
Rx Only

TriphroCaps
Softgels

100 SOFTGELS

TRIGEN
LABORATORIES

Principal Display Panel - 100 Softgel Bottle Label
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 DEA Schedule     
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 (UNII: 2G86QN327L)  
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)  
Product Characteristics
Color RED Score no score
Shape OVAL Size 13mm
Flavor Imprint Code T9
Contains     
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 10/01/2009
Labeler - Trigen Laboratories, Inc. (830479668)

Revised: 5/2013
Document Id: ad5e7aa2-7649-4ccb-9d34-b1d8cc1145e4
Set id: 189aa6c1-e279-4ee5-968f-da869c1cda5a
Version: 1
Effective Time: 20130515
 
Trigen Laboratories, Inc.