Folivane-OB
Folivane™-OB Capsules
FULL PRESCRIBING INFORMATION: CONTENTS*
- FOLIVANE-OB DESCRIPTION
- INDICATIONS
- FOLIVANE-OB CONTRAINDICATIONS
- WARNING
- PRECAUTION
- FOLIVANE-OB ADVERSE REACTIONS
- OVERDOSAGE
- FOLIVANE-OB DOSAGE AND ADMINISTRATION
- HOW SUPPLIED
- STORAGE
- PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
FULL PRESCRIBING INFORMATION
Rx Only
FOLIVANE-OB 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 Each Capsule contains |
%DV for Pregnant and Lactating Women |
|
| Ferrous Fumarate (anhydrous)(Equiv. to about 42.5 mg of Elemental Iron) | 130 mg | 722% |
| Polysaccharide Iron Complex (Equiv. to about 42.5 mg of Elemental Iron) | 92.4 mg | 513% |
|
Vitamin C |
210 mg | 350% |
| Folic Acid | 1 mg | 125% |
| Vitamin B1 (thiamine mononitrate) | 5 mg | 294% |
| Vitamin B2 (riboflavin) | 5 mg | 250% |
| Vitamin B 3 (niacin) | 20 mg | 100% |
| Vitamin B5 (d-calcium pantothenate) | 7 mg | 70% |
| Vitamin B6 (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% |
Inactive Ingredients: Hypromellose, Microcrystalline Cellulose, Magnesium Stearate, Titanium Dioxide, FD&C Blue #1, Fumed Silica, FD&C Red #40.
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.
FOLIVANE-OB 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. |
WARNING
Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where vitamin B12 is deficient.
PRECAUTION
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.
FOLIVANE-OB ADVERSE REACTIONS
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.
OVERDOSAGE
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.
FOLIVANE-OB 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 dosage. 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, light-resistant 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.
Rx Only
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
www.trigenlab.com
Rev. 05/13
PRINCIPAL DISPLAY PANEL - 30 Capsule Bottle Label
13811-535-30
Rx Only
Folivane™-OB
with Ascorbic Acid Precursors
PRENATAL MULTIVITAMIN SUPPLEMENT
30 CAPSULES
TRIGEN
LABORATORIES
Folivane-OBFerrous 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
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