Folivane-Plus with Ascorbic Acid Precursors: Package Insert and Label Information

FOLIVANE-PLUS WITH ASCORBIC ACID PRECURSORS- ferrous fumarate, iron, ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hydrochloride, folic acid, cyanocobalamin, biotin and calcium pantothenate capsule
Trigen Laboratories, LLC

SUPPLEMENT FACTS

Rev.072018
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Folivane™ — Plus is a prescription multivitamin nutritional supplement indicated for improving nutritional status in adults with certainty illnesses or vitamin deficiencies. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.

CONTRAINDICATIONS

Folivane™ — Plus is contraindicated in patients with known hypersensitivity to any of its ingredients; also, all iron compounds are contraindicated in patients with hemosiderosis, hemochromatosis, or hemolytic anemias. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

WARNINGS

WARNING BOX
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PRECAUTIONS

General: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where B12 is deficient. Folic acid in doses above 0.1 mg daily may obscure pernicious anemia assessment, such that hematologic remission can occur while neurological manifestations remain progressive.


Biotin levels higher than the recommended daily allowance may cause interference with some laboratory tests, including 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.

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


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

DRUG INTERACTIONS

Folivane™ — Plus 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

Folic Acid: Allergic sensitizations have been reported following both oral and parenteral administration of folic acid.


Ferrous Fumarate: Gastrointestinal disturbances (anorexia, nausea, diarrhea, constipation) occur occasionally, but are usually mild and may subside with continuation of therapy. Although the absorption of iron is best when taken between meals, taking Folivane™ — Plus after meals may diminish occasional G.I. disturbances. Folivane™ — Plus is best absorbed when taken at bedtime.

OVERDOSAGE

Acute overdosage of iron may cause abdominal pain, nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other more chronic symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300 mg/kg body weight. Toxic effects are seen at 10-20 mg/kg elemental iron. When overdoses are ingested by children, severe reactions, including fatalities, have resulted. Folivane™-Plus should be stored beyond the reach of children to prevent against accidental iron poisoning. Keep this product out of the reach of children.

Treatment: For specific therapy, exchange transfusion and chelating agents should be used. For general management, perform gastric lavage with sodium bicarbonate solution or milk. Administer intravenous fluids and electrolytes and use oxygen.

DESCRIPTION

Folivane™ — Plus are maroon capsules imprinted “T539” in white.

DIRECTIONS FOR USE

Adults and children over 12 years of age: One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dosage.

HOW SUPPLIED

Folivane™ — Plus is dispensed in child-resistant bottles of 90 capsules.

Product Code: 13811-539-90

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature].

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 at 1-770-509-4500 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


PLR-FOLPLUS-00001-1 Rev. 12/2021


Manufactured For: trigen logo
Trigen Laboratories, LLC
Alpharetta, GA 30005

PRINCIPAL DISPLAY PANEL

Folivane-Plus with Ascorbic Acid Precursors 90ct

13811-539-90

Folivane Plus BL Rev. 12/2021
(click image for full-size original)
FOLIVANE-PLUS WITH ASCORBIC ACID PRECURSORS
ascorbic acid, thiamine mononitrate, riboflavin, niacin, pyridoxine hcl, folic acid, cyanocobalamin, biotin, d-calcium pantothenate, ferrous fumarate, and polysaccharide iron complex capsule
Product Information
Product Type Item Code (Source) NDC:13811-539
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
FERROUS FUMARATE (FERROUS CATION) FERROUS CATION 62.5 mg
IRON (IRON) IRON 62.5 mg
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 210 mg
THIAMINE MONONITRATE (Thiamine ION) THIAMINE 5 mg
RIBOFLAVIN (RIBOFLAVIN) RIBOFLAVIN 5 mg
NIACIN (NIACIN) NIACIN 20 mg
PYRIDOXINE HYDROCHLORIDE (PYRIDOXINE) PYRIDOXINE HYDROCHLORIDE 25 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 10 ug
BIOTIN (BIOTIN) BIOTIN 300 ug
CALCIUM PANTOTHENATE (PANTOTHENIC ACID) PANTOTHENIC ACID 7 mg
Inactive Ingredients
Ingredient Name Strength
HYPROMELLOSES
TITANIUM DIOXIDE
FD&C RED NO. 40
FD&C BLUE NO. 1
MICROCRYSTALLINE CELLULOSE
MAGNESIUM STEARATE
SILICON DIOXIDE
Product Characteristics
Color red (maroon) Score no score
Shape CAPSULE Size 23mm
Flavor Imprint Code T539
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:13811-539-90 90 CAPSULE in 1 BOTTLE None
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/01/2017
Labeler — Trigen Laboratories, LLC (830479668)

Revised: 01/2022 Trigen Laboratories, LLC

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