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

NHRIC Code(s): 53808-0987(NDC:13811-525), 53808-0987-1
Packager: State of Florida DOH Central Pharmacy
This is a repackaged label.
Source NDC Code(s): 13811-525

Category: DIETARY SUPPLEMENT
DEA Schedule: None
Marketing Status: Dietary Supplement

Drug Label Information

Updated April 24, 2014

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HEALTH CLAIM
Rx Only

Rx Only
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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 ...

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 ...

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

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

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.
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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 ...

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.

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

Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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DOSAGE AND ADMINISTRATION
Take one TriphroCaps softgel daily or as prescribed by a physician. On dialysis days, take one TriphroCaps softgel after dialysis.

Take one TriphroCaps softgel daily or as prescribed by a physician. On dialysis days, take one TriphroCaps softgel after dialysis.
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HOW SUPPLIED
TriphroCaps are supplied in bottles of 100 softgel capsules. They are supplied by State of Florida DOH Central Pharmacy as follows: NDCQuantity/FormColorSource Prod ...

TriphroCaps are supplied in bottles of 100 softgel capsules.

They are supplied by State of Florida DOH Central Pharmacy as follows:

NDC Quantity/Form Color Source Prod. Code

53808-0987-1 30 Capsules in a Blister Pack RED 13811-525

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STORAGE
Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP controlled room temperature].
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HEALTH CLAIM
Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888-987-4436).
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WARNINGS
KEEP OUT OF REACH OF CHILDREN

KEEP OUT OF REACH OF CHILDREN
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HEALTH CLAIM
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 ...

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

This Product was Repackaged By:

State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States

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PACKAGE LABEL
Label Image for 53808-0987

Label Image for 53808-0987

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Supplement Facts Servings per Bottle: 100
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%

NDC	Quantity/Form	Color	Source Prod. Code
53808-0987-1	30 Capsules in a Blister Pack	RED	13811-525

INGREDIENTS AND APPEARANCE

Product Information

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:53808-0987(NDC:13811-525)
Route of Administration	ORAL

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
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)	PANTOTHENIC ACID	5 mg
BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04)	BIOTIN	150 ug

Ingredient Name	Strength
Inactive Ingredients
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)

#	Item Code	Package Description	Marketing Start Date	Marketing End Date
Packaging
1	NHRIC:53808-0987-1	30 in 1 BLISTER PACK

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
DIETARY SUPPLEMENT		01/01/2013

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

Labeler - State of Florida DOH Central Pharmacy (829348114)

Name	Address	ID/FEI	Business Operations
Establishment
State of Florida DOH Central Pharmacy		829348114	repack(53808-0987)

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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%

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