What is Folivane and how is it used?
Folivane is a prescription and over the counter medicine used as a multivitamin and iron product used to treat or prevent vitamin deficiency. Folivane may be used alone or with other medications.
Folivane belongs to a class of drugs called Iron Products; Vitamin and Mineral Combinations.
It is not known if Folivane is safe and effective in children.
What are the possible side effects of Folivane?
Folivane may cause serious side effects including:
- difficulty breathing,
- swelling of your face, lips, tongue, or throat,
- severe dizziness,
- rash, and
Get medical help right away, if you have any of the symptoms listed above.
The most common side effects of Folivane include:
- loss of appetite,
- diarrhea, and
Tell the doctor if you have any side effect that bothers you or that does not go away.
These are not all the possible side effects of Folivane. For more information, ask your doctor or pharmacist.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
(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
Folivane™-OB are blue opaque capsules imprinted “T535” on one side. Folivane™-OB is a prescription prenatal multivitamin supplement.
|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.|
Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, Fumed Silica, FD&C Red #40.
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.
Folivane™-OB is dispensed in child-resistant bottles of 30 capsules.
Product Code: 13811-535-30
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
Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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.
No Information provided
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B is deficient.
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.
Safety and effectiveness of this product have not been established in pediatric patients.
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.
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.
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.
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.
No information provided. Please refer to the WARNINGS and PRECAUTIONS sections.
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