FOLIVANE-OB- ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, manganese sulfate, and zinc sulfate capsule

Folivane-OB by

Drug Labeling and Warnings

Folivane-OB by is a Other medication manufactured, distributed, or labeled by Trigen Laboratories, LLC. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SUPPLEMENT FACTS

Other Ingredients: Capsule (Hypromellose, Titanium Dioxide, FD&C Blue #1, FD&C Red #40) Microcrystalline Cellulose, Magnesium Stearate, and Fumed Silica.

Folivane™-OB is a prescription prenatal supplement designed to improve the nutritional status of women throughout pregnancy and during the postnatal period to lactating and non-lactating mothers. Folivane™-OB may also be used to improve the nutritional status of women. DO NOT ADMINISTER TO CHILDREN UNDER THE AGE OF 12.

CONTRAINDICATIONS

Folivane™-OB 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 anemia. Pernicious anemia is a contraindication, as folic acid may obscure its signs and symptoms.

WARNING

 WARNING: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUTOF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately.

PRECAUTION

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 cardiovascular diagnostic tests (e.g. troponin) and hormone test, and may 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™-OB 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 sensitization 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, giving Folivane™-OB after meals may control occasional G.I. disturbances. Folivane™-OB 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™-OB should be stored beyond the reach of children to prevent against accidental iron poisoning.

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™-OB are blue opaque capsules imprinted with “T535” in white ink on both cap and body.

DIRECTIONS FOR USE

One (1) capsule daily, between meals, or as prescribed by a physician.  Do not exceed recommended dosage.

HOW SUPPLIED

Folivane™-OB is dispensed in child-resistant bottles of 30 capsules.

Product Code: 13811-535-30

STORAGE

Store at 20°-25°C (68°-77°F), excursions permitted to 15°-30°C (59°-86°F) [See USP Controlled Room Temperature]. Dispense in a tight, light-resistant container as defined in the USP with a child-resistant closure.

KEEP OUT OF REACH OF CHILDREN.

HEALTH CLAIM

For use on the order of a healthcare practitioner.

Call your doctor about side effects. To report side effects, call Trigen Laboratories at 1-877-482-3788 or FDA at 1-800-FDA-1088.

Customer Service: 1-877-482-3788                                                                                                              Rev. 09/2019

Manufactured for:
Trigen Laboratories, LLC
Bridgewater, NJ 08807

PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label

13811-535-30

Folivane™-OB
with Ascorbic Acid Precursors

PRENATAL MULTIVITAMIN SUPPLEMENT

30 CAPSULES

INGREDIENTS AND APPEARANCE

FOLIVANE-OB 
ferrous fumarate, iron, ascorbic acid, folic acid, thiamine mononitrate, riboflavin, niacin, calcium pantothenate, pyridoxine hydrochloride, biotin, cyanocobalamin, cupric sulfate, magnesium sulfate, manganese sulfate, and zinc sulfate capsule

Product Information
Product Type	DIETARY SUPPLEMENT	Item Code (Source)	NHRIC:13811-535
Route of Administration	ORAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
Ferrous Fumarate (UNII: R5L488RY0Q) (Ferrous Cation - UNII:GW89581OWR)	Ferrous Cation	42.5 mg
Iron (UNII: E1UOL152H7) (Iron - UNII:E1UOL152H7)	Iron	42.5 mg
Ascorbic Acid (UNII: PQ6CK8PD0R) (Ascorbic Acid - UNII:PQ6CK8PD0R)	Ascorbic Acid	210 mg
Folic Acid (UNII: 935E97BOY8) (Folic Acid - UNII:935E97BOY8)	Folic Acid	1 mg
Thiamine Mononitrate (UNII: 8K0I04919X) (Thiamine Ion - UNII:4ABT0J945J)	Thiamine	5 mg
Riboflavin (UNII: TLM2976OFR) (Riboflavin - UNII:TLM2976OFR)	Riboflavin	5 mg
Niacin (UNII: 2679MF687A) (Niacin - UNII:2679MF687A)	Niacin	20 mg
Calcium Pantothenate (UNII: 568ET80C3D) (Calcium Cation - UNII:2M83C4R6ZB)	Calcium Cation	7 mg
Pyridoxine Hydrochloride (UNII: 68Y4CF58BV) (Pyridoxine - UNII:KV2JZ1BI6Z)	Pyridoxine Hydrochloride	25 mg
Biotin (UNII: 6SO6U10H04) (Biotin - UNII:6SO6U10H04)	Biotin	300 ug
Cyanocobalamin (UNII: P6YC3EG204) (Cyanocobalamin - UNII:P6YC3EG204)	Cyanocobalamin	10 ug
Cupric Sulfate (UNII: LRX7AJ16DT) (Cupric Cation - UNII:8CBV67279L)	Cupric Cation	800 ug
MAGNESIUM SULFATE HEPTAHYDRATE (UNII: SK47B8698T) (Magnesium Cation - UNII:T6V3LHY838)	MAGNESIUM SULFATE HEPTAHYDRATE	6.9 mg
Manganese Sulfate (UNII: W00LYS4T26) (Manganese Cation (2+) - UNII:H6EP7W5457)	Manganese Cation (2+)	1.3 mg
Zinc Sulfate (UNII: 89DS0H96TB) (Zinc Cation - UNII:13S1S8SF37)	Zinc Cation	18.2 mg

Inactive Ingredients
Ingredient Name	Strength
Hypromelloses (UNII: 3NXW29V3WO)
Cellulose, Microcrystalline (UNII: OP1R32D61U)
Magnesium Stearate (UNII: 70097M6I30)
Titanium Dioxide (UNII: 15FIX9V2JP)
FD&C Blue No. 1 (UNII: H3R47K3TBD)
FD&C Red No. 40 (UNII: WZB9127XOA)
SILICON DIOXIDE (UNII: ETJ7Z6XBU4)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NHRIC:13811-535-30	30 in 1 BOTTLE, PLASTIC

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
DIETARY SUPPLEMENT		01/01/2010

Supplement Facts
Serving Size :		Serving per Container :
	Amount Per Serving	% Daily Value
color
imprint
scoring	1
shape
size (solid drugs)	22 mm

Labeler - Trigen Laboratories, LLC (830479668)