Folivane

Folivane™-OB is a 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.

Adults (persons over 12 years of age), One (1) capsule daily, between meals, or as prescribed by a physician. Do not exceed recommended dos age. Do not administer to children under the age of 12.

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.

WARNINGS

Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.

PRECAUTIONS

General

Folic acid in doses above 0.1 mg - 0.4 mg daily may obscure pernicious anemia, in that hematologic remission can occur while neurological manifestations remain progressive.

Pediatric Use

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

Geriatric Use

No clinical studies have been performed in patients age 65 and older to determine whether older persons respond differently from younger persons. Dosage should always begin at the low end of the dosage scale and should consider that elderly persons may have decreased hepatic, renal, or cardiac function, and/or concomitant diseases.

No Information provided

Folic Acid

Allergic sensitization has 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.

Iron

Signs And Symptoms

Iron is toxic. Acute overdosage of iron may cause nausea and vomiting and, in severe cases, cardiovascular collapse and death. Other symptoms include pallor and cyanosis, melena, shock, drowsiness and coma. The estimated overdose of orally ingested iron is 300-mg/kg body weight. 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.

No information provided.

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) . Keep in a cool, dry place. Capsules are not USP. Dispense in a tight, lightresistant container as defined in the USP with a child-resistant closure.

Call your doctor about side effects. You may report side effects by calling 888 9 TRIGEN (888- 987-4436).

KEEP OUT OF THE REACH OF CHILDREN.

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. Revised : May 2013