Label: FERIVA 21 7- ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acids and succinic acid tablet
- NHRIC Code(s): 75854-318-28
- Packager: Avion Pharmaceuticals, LLC
- Category: DIETARY SUPPLEMENT
- DEA Schedule: None
- Marketing Status: Dietary Supplement
Updated January 7, 2020
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STATEMENT OF IDENTITY
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.
Serving Size: 1 tablet
% Daily Value for
Each Red Iron Tablet Contains: Vitamin C (as Ascorbic Acid) 175 mg 292% 292% Zinc (as Zinc Bisglycinate) 10 mg 67% 67% Vitamin B12 (as Cyanocobalamin) 12 mcg 200% 150% Iron (as Ferrrous Asparto
75 mg 417% 417% Folate (as ((6S)-N5-methyltetrahydrofolic
salt (molar equivalent to 600
mcg of folic acid) and folic acid,
USP 400 mcg)
1 mg 250% 125% Succinic Acid 150 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.
FeRiva 21/7® is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency.
FeRiva 21/7® is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.
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.
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.
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
INGREDIENTS AND APPEARANCE
FERIVA 21 7
ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acids and succinic acid tablet
Product Information Product Type DIETARY SUPPLEMENT Item Code (Source) NHRIC:75854-318 Route of Administration ORAL Active Ingredient/Active Moiety Ingredient Name Basis of Strength Strength ASCORBIC ACID (UNII: PQ6CK8PD0R) (ASCORBIC ACID - UNII:PQ6CK8PD0R) ASCORBIC ACID 175 mg ZINC GLYCINATE (UNII: 681VJX72FE) (ZINC CATION - UNII:13S1S8SF37) ZINC GLYCINATE 10 mg CYANOCOBALAMIN (UNII: P6YC3EG204) (CYANOCOBALAMIN - UNII:P6YC3EG204) CYANOCOBALAMIN 12 ug FERROUS ASPARTO GLYCINATE (UNII: H7426RGB3L) (FERROUS CATION - UNII:GW89581OWR) FERROUS CATION 75 mg FOLIC ACID (UNII: 935E97BOY8) (FOLIC ACID - UNII:935E97BOY8) FOLIC ACID 1 mg SUCCINIC ACID (UNII: AB6MNQ6J6L) (SUCCINIC ACID - UNII:AB6MNQ6J6L) SUCCINIC ACID 150 mg Inactive Ingredients Ingredient Name Strength 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 Code Package Description Marketing Start Date Marketing End Date 1 NHRIC:75854-318-28 28 in 1 CARTON 1 1 in 1 BLISTER PACK Marketing Information Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date DIETARY SUPPLEMENT 10/20/2014 Supplement Facts Serving Size : Serving per Container : Amount Per Serving % Daily Value color color scoring 1 shape size (solid drugs) 7 mm imprint Labeler - Avion Pharmaceuticals, LLC (040348516) Establishment Name Address ID/FEI Business Operations Avion Pharmaceuticals, LLC 040348516 manufacture(75854-318)