Label: FERIVA 21 7- ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acids and succinic acid tablet

  • Category: DIETARY SUPPLEMENT
  • DEA Schedule: None
  • Marketing Status: Dietary Supplement

Drug Label Information

Updated January 7, 2020

If you are a consumer or patient please visit this version.

  • STATEMENT OF IDENTITY

    DESCRIPTION
    FeRiva 21/7® tablets for oral administration is a 28-day iron supplement regimen that consists of 21 red, oval-shaped iron tablets and 7 purple, oval-shaped placebo tablets. Each red, oval-shaped iron tablet is debossed with “21” and “7” separated by a line in the middle on the top-side of the tablet and blank on the other side. Each purple, oval shaped placebo tablet is blank on both sides of the tablet.

    Supplement Facts
    Serving Size: 1 tablet
    % Daily
    Value
    % Daily Value for
    Pregnant &
    Lactating Women
    Each Red Iron Tablet Contains:
    Vitamin C (as Ascorbic Acid)175 mg292%292%
    Zinc (as Zinc Bisglycinate)10 mg67%67%
    Vitamin B12 (as Cyanocobalamin)12 mcg200%150%
    Iron (as Ferrrous Asparto
    Glycinate) Sumalate®
    75 mg417%417%
    Folate (as ((6S)-N5-methyltetrahydrofolic
    acid calcium
    salt (molar equivalent to 600
    mcg of folic acid) and folic acid,
    USP 400 mcg)
    1 mg250%125%
    Succinic Acid150 mg
    † Daily Value (DV) not established.
    PURPLE PLACEBO TABLETS do not contain ANY vitamins, minerals or other dietary ingredients. Please see OTHER INGREDIENTS section below for the listing of the inert ingredients.

    OTHER INGREDIENTS (RED IRON TABLETS)
    Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Coating contains: FD&C Red #40, HMPC, titanium dioxide and triacetin.

    OTHER INGREDIENTS (PURPLE PLACEBO TABLETS)
    Croscarmellose sodium, dicalcium phosphate, magnesium stearate, microcrystalline cellulose, silicon dioxide, and stearic acid. Coating contains: HMPC, titanium dioxide, triacetin, and FD&C Red #3, FD&C Blue #1.

    INDICATIONS
    FeRiva 21/7® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.

    CONTRAINDICATIONS
    FeRiva 21/7® 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.

    ADVERSE REACTIONS
    Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

  • DOSAGE & ADMINISTRATION

    DOSAGE AND ADMINISTRATION

    Usual dosage is one tablet daily with or without food or as prescribed by your healthcare provider. The FeRiva 21/7® Tablets blister pack supplies a 28-day course of iron therapy that consists of 21 red iron tablets and 7 purple placebo tablets. Take 1 red iron tablet daily for 21 days, followed by 1 purple placebo tablet daily for 7 days. After 28 tablets have been taken a new course may be started if prescribed.

    HOW SUPPLIED

    FeRiva 21/7® tablets blister pack (75854-318-28) contains 21 red iron tablets and 7 purple placebo tablets. The listed product number is not a National Drug Code. Instead Avion Pharmaceuticals has assigned a product code formatted according to standard industry practice to meet the formatting requirements of pharmacy and health insurance computer systems.

    Keep out of reach of children. Store between 20°- 25°C (68°- 77°F).

    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.

    Avion Pharmaceuticals, LLC
    Alpharetta, GA 30022
    1-888-61-AVION L-0057 Rev. 1219-02

  • PRINCIPAL DISPLAY PANEL - 28 tablet container label

    75854-318-28       RX ONLY

    FeRiva 21/7

    IRON SUPPLEMENT

    Unique, Innovative Iron Supplementation System
    • Enhanced GI Tolerability • Improved Absorption • Easy-to-swallow tablets

    Once Daily
    28-DAY IRON SUPPLEMENT REGIMEN

    Avion
    PHARMACEUTICALS

    PRINCIPAL DISPLAY PANEL - 100 tablets
  • INGREDIENTS AND APPEARANCE
    FERIVA 21 7 
    ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acids and succinic acid tablet
    Product Information
    Product TypeDIETARY SUPPLEMENTItem Code (Source)NHRIC:75854-318
    Route of AdministrationORAL
    Active Ingredient/Active Moiety
    Ingredient NameBasis of StrengthStrength
    ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID175 mg
    ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC GLYCINATE10 mg
    CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN12 ug
    FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION75 mg
    FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID1 mg
    SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L) SUCCINIC ACID150 mg
    Inactive Ingredients
    Ingredient NameStrength
    ANHYDROUS DIBASIC CALCIUM PHOSPHATE (UNII: L11K75P92J)  
    MICROCRYSTALLINE CELLULOSE (UNII: OP1R32D61U)  
    STEARIC ACID (UNII: 4ELV7Z65AP)  
    SILICON DIOXIDE (UNII: ETJ7Z6XBU4)  
    MAGNESIUM STEARATE (UNII: 70097M6I30)  
    CROSCARMELLOSE SODIUM (UNII: M28OL1HH48)  
    HYPROMELLOSE, UNSPECIFIED (UNII: 3NXW29V3WO)  
    TITANIUM DIOXIDE (UNII: 15FIX9V2JP)  
    TRIACETIN (UNII: XHX3C3X673)  
    FD&C RED NO. 3 (UNII: PN2ZH5LOQY)  
    FD&C RED NO. 40 (UNII: WZB9127XOA)  
    FD&C BLUE NO. 1 (UNII: H3R47K3TBD)  
    Packaging
    #Item CodePackage DescriptionMarketing Start DateMarketing End Date
    1NHRIC:75854-318-2828 in 1 CARTON
    11 in 1 BLISTER PACK
    Marketing Information
    Marketing CategoryApplication Number or Monograph CitationMarketing Start DateMarketing End Date
    DIETARY SUPPLEMENT10/20/2014
    Supplement Facts
    Serving Size : Serving per Container :
    Amount Per Serving% Daily Value
    color
    color
    scoring1
    shape
    size (solid drugs)7 mm
    imprint
    Labeler - Avion Pharmaceuticals, LLC (040348516)
    Establishment
    NameAddressID/FEIBusiness Operations
    Avion Pharmaceuticals, LLC040348516manufacture(75854-318)