TriphroCaps

TRIGEN Laboratories, Inc.

TriphroCaps Softgels

FULL PRESCRIBING INFORMATION: CONTENTS*

• TRIPHROCAPS DESCRIPTION
• TRIPHROCAPS INDICATIONS AND USAGE
• TRIPHROCAPS CONTRAINDICATIONS
• WARNINGS
• PRECAUTIONS
  • Pediatric Use
  • Geriatric Use
• TRIPHROCAPS ADVERSE REACTIONS
• TRIPHROCAPS DOSAGE AND ADMINISTRATION
• HOW SUPPLIED
• STORAGE
• PRINCIPAL DISPLAY PANEL - 100 Softgel Bottle Label

FULL PRESCRIBING INFORMATION

Rx Only

TRIPHROCAPS 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."

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.

TRIPHROCAPS 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.

TRIPHROCAPS 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.

TRIPHROCAPS ADVERSE REACTIONS

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

TRIPHROCAPS 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
R_x Only

TriphroCaps
Softgels

100 SOFTGELS

TRIGEN
LABORATORIES