Generic Name: ferrous bisglycinate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium
Dosage Form: capsule
Disclaimer: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA.
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Rx Only Dietary Supplement
DESCRIPTION: FeRiva FA® for oral administration is a prenatal/postnatal iron supplement that is a red gel capsule.
Serving Size: 1 Capsule
|Amount per Serving:||% Daily
|Iron (as ferrous asparto glycinate - Sumalate® ferrous bis-glycinate chelate - Ferrochel®
and ferrous fumarate)
|Vitamin C (as ascorbic acid)||175 mg||292%|
|Folate (as ((6S)-N5-methyltetrahydrofolic acid calcium salt (molar equivalent to 600 mcg
of folic acid) and folic acid, USP 400 mcg)
|Vitamin B12 (as cyanocobalamin)||12 mcg||200%|
|Copper (as cupric oxide)||1.5 mg||75%|
|Docusate sodium||50 mg||*|
OTHER INGREDIENTS: Silicon dioxide and magnesium stearate. Gel capsule: (bovine gelatin, titanium dioxide, FD&C blue #1 and FD&C red #40).
INDICATIONS: FeRiva FA® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of women throughout pregnancy and in the postnatal period for both lactating and nonlactating mothers.
CONTRAINDICATIONS: FeRiva FA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.
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.
PRECAUTIONS: Folic acid alone is improper therapy in the treatment of pernicious anemia and other megaloblastic anemias where Vitamin B12 is deficient. Folic acid in doses above 1.0 mg daily may obscure pernicious anemia in that hematologic remission can occur while neurological manifestations progress. While prescribing this nutritional supplement for pregnant women, nursing mothers or for women prior to conception, their medical condition and other drugs, herbs and/or supplements consumption should be considered.
PEDIATRIC USE: Safety and effectiveness have not been studied in pediatric patients.
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one capsule daily or as directed by a physician.
HOW SUPPLIED: In child-resistant bottles of 30 capsules (75854-0319-30). The listed product number is not a National Drug Code, but has instead been formatted to comply with standard industry practice for pharmacy computer systems.
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]
Avion Pharmaceuticals, LLC
Alpharetta, GA 30022
Sumalate® is a registered trademark of Albion Laboratories, Inc., covered by one or more claims of U.S. Patent Nos. 6,716,814, 8,007,846, and 8,425,956.
Ferrochel® is a registered trademark of Albion Laboratories, Inc. covered by U.S. Patents 6,716,814 & 7,838,042.
THESE STATEMENTS HAVE NOT BEEN EVALUATED BY THE FOOD AND DRUG ADMINISTRATION. THIS PRODUCT IS NOT INTENDED TO DIAGNOSE, TREAT, CURE OR PREVENT ANY DISEASE.
KEEP THIS AND ALL MEDICATIONS OUT OF THE REACH OF CHILDREN.
PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated
|Labeler - Avion Pharmaceuticals, LLC (965450542)|
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- Drug class: iron products