Label: 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
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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, oval softgel capsules, imprinted "T9."
Supplement Facts
Servings per Bottle: 100Serving Size: 1 Softgel Capsule
Each Softgel Capsule contains%DV Adults & Children
4 Years or MoreFolate 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.
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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
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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 pernicious anemia in that hematologic remission can occur while neurological manifestations remain progressive.
THIS PRODUCT CONTAINS SOY.
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PRECAUTIONS
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
- DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- HEALTH CLAIM
- WARNINGS
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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 equivalence.
Manufactured for:
TRIGEN Laboratories, Inc., Sayreville, NJ 08872
www.trigenlab.comThis Product was Repackaged By:
State of Florida DOH Central Pharmacy
104-2 Hamilton Park Drive
Tallahassee, FL 32304
United States
- PACKAGE LABEL
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INGREDIENTS AND APPEARANCE
TRIPHROCAPS
folic acid, ascorbic acid, niacinamide, thiamine mononitrate, riboflavin, pyridoxine hydrochloride, cyanocobalamin, calcium pantothenate, and biotin capsuleProduct Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:53808-0987(NDC: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) 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) Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:53808-0987-1 30 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 01/01/2013 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color shape scoring 1 imprint size (solid drugs) 13 mm Labeler - State of Florida DOH Central Pharmacy (829348114) Establishment Name Address ID/FEI Business Operations State of Florida DOH Central Pharmacy 829348114 repack(53808-0987)
