Folivane Generic Name: multivitamin capsules Brand Name: Folivane side effects drug center folivane (multivitamin capsules) drug Related Drugs BiferaRx PROFESSIONAL SIDE EFFECTS Contents Drug Description Indications & Dosage Side Effects & Drug Interactions Warnings & Precautions Overdosage & Contraindications Clinical Pharmacology Medication Guide Drug Description 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) Capsules DESCRIPTION Folivane™-OB are blue opaque capsules imprinted “T535” on one side. Folivane™-OB is a prescription prenatal multivitamin supplement. Supplement Facts Servings per Bottle: 30 Serving Size: 1 Capsule %DV for Pregnant and Lactating Women Each Capsule contains Ferrous Fumarate (anhydrous) (Equiv. to about 42.5 mg of Elemental Iron) 130 mg 722% Polysaccharide Iron Complex (Equiv. to 92.4 mg 513% about 42.5 mg of Elemental Iron) Vitamin C* (ascorbic acid) 210 mg 350% Folic Acid 1 mg 125% Vitamin B1 (thiamine mononitrate) 5 mg 294% Vitamin B2 (riboflavin) 5 mg 250% Vitamin B3 (niacin) 20 mg 100% Vitamin B5 (d-calcium pantothenate) 7 mg 70% Vitamin Bg (pyridoxine HCl) 25 mg 1000% Vitamin B7 (biotin) 300 mcg 100% Vitamin B12 (cyanocobalamin) 10 mcg 125% Copper (as copper sulfate) 800 mcg 40% Magnesium (as magnesium sulfate) 6.9 mg 2% Manganese (as manganese sulfate) 1.3 mg 57% Zinc (as zinc sulfate) 18.2 mg 121% *Also containing Ascorbic Acid Precursors as (1) Acid Metabolites including niacinamide ascorbate, calcium ascorbate, magnesium ascorbate, potassium ascorbate and sodium ascorbate (2) Basic Amino Acids including lysine acetate; (3) Flavonoids including hesperidin; and (4 ) Glutathione. Inactive Ingredients Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, Fumed Silica, FD&C Red #40. Indications & Dosage INDICATIONS 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. DOSAGE AND ADMINISTRATION 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. 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]. 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 Side Effects & Drug Interactions SIDE EFFECTS 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. DRUG INTERACTIONS No Information provided Warnings & Precautions 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. Overdosage & Contraindications OVERDOSE 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. 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: Accidental overdose of iron-containing products is a leading cause of fatal poisoning in children under 6. KEEP THIS PRODUCT OUT OF REACH OF CHILDREN. In case of accidental overdose, call a doctor or poison control center immediately. Clinical Pharmacology CLINICAL PHARMACOLOGY No information provided. Medication Guide PATIENT INFORMATION No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
