Label: FERIVA FA- ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated
- NDC Code(s): 75854-319-30
- Packager: Avion Pharmaceuticals, LLC
- Category: HUMAN PRESCRIPTION DRUG LABEL
- DEA Schedule: None
- Marketing Status: unapproved drug other
DISCLAIMER: This drug has not been found by FDA to be safe and effective, and this labeling has not been approved by FDA. For further information about unapproved drugs, click here.
Updated January 24, 2017
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- BOXED WARNING(What is this?)
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.Close
- SPL UNCLASSIFIED SECTION
Rx Only Dietary SupplementClose
DESCRIPTION: FeRiva FA® for oral administration is a prenatal/postnatal iron supplement that is a red gel capsule.
- Daily Value (DV) not established
Serving Size: 1 Capsule
Amount per Serving: % Daily
Iron (as ferrous asparto glycinate - Sumalate® ferrous bis-glycinate chelate - Ferrochel®
and ferrous fumarate)
110 mg 611% 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)
1 mg 250% Vitamin B12 (as cyanocobalamin) 12 mcg 200% Biotin 300 mcg 100% Copper (as cupric oxide) 1.5 mg 75% Docusate sodium 50 mg *
- INACTIVE INGREDIENT
OTHER INGREDIENTS: Silicon dioxide and magnesium stearate. Gel capsule: (bovine gelatin, titanium dioxide, FD&C blue #1 and FD&C red #40).Close
- INDICATIONS & USAGE
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.Close
CONTRAINDICATIONS: FeRiva FA™ is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.Close
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.Close
- PEDIATRIC USE
PEDIATRIC USE: Safety and effectiveness have not been studied in pediatric patients.Close
- ADVERSE REACTIONS
ADVERSE REACTIONS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.Close
- DOSAGE & ADMINISTRATION
DOSAGE AND ADMINISTRATION: Before, during and/or after pregnancy, one capsule daily or as directed by a physician.Close
- HOW SUPPLIED
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.Close
- STORAGE AND HANDLING
STORAGE: Store at 20° - 25°C (68° - 77°F); excursions permitted to 15° - 30°C (59° - 86°F) [See USP Controlled Room Temperature.]Close
- SPL UNCLASSIFIED SECTION
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.Close
- PACKAGE LABEL.PRINCIPAL DISPLAY PANEL
- INGREDIENTS AND APPEARANCE
ferrous bisglycinate, ferrous asparto glycinate, ferrous fumarate, ascorbic acid, folic acid, cyanocobalamin, biotin, cupric oxide and docusate sodium capsule, gelatin coated
Product Information Product Type HUMAN PRESCRIPTION DRUG Item Code (Source) NDC:75854-319 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength FERROUS BISGLYCINATE (UNII: SFW1D987QV) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 36.7 mg FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 36.7 mg FERROUS FUMARATE (UNII: R5L488RY0Q) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 36.7 mg ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 175 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug BIOTIN (UNII: 6SO6U10H04) (BIOTIN - UNII:6SO6U10H04) BIOTIN 300 ug CUPRIC OXIDE (UNII: V1XJQ704R4) (CUPRIC CATION - UNII:8CBV67279L) CUPRIC CATION 1.5 mg DOCUSATE SODIUM (UNII: F05Q2T2JA0) (DOCUSATE - UNII:M7P27195AG) DOCUSATE SODIUM 50 mg Inactive Ingredients Ingredient Name Strength SILICON DIOXIDE (UNII: ETJ7Z6XBU4) MAGNESIUM STEARATE (UNII: 70097M6I30) GELATIN (UNII: 2G86QN327L) TITANIUM DIOXIDE (UNII: 15FIX9V2JP) FD&C BLUE NO. 1 (UNII: H3R47K3TBD) FD&C RED NO. 40 (UNII: WZB9127XOA) Product Characteristics Color RED Score no score Shape CAPSULE Size 22mm Flavor Imprint Code Contains Packaging # Item Code Package Description Marketing Start Date Marketing End Date 1 NDC:75854-319-30 30 in 1 BOTTLE; Type 0: Not a Combination Product 12/18/2014 Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date unapproved drug other 12/18/2014 Labeler - Avion Pharmaceuticals, LLC (965450542)