FeRiva 21 7: Package Insert and Label Information

FERIVA 21 7- ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acid and succinic acid tablet
Avion Pharmaceuticals, LLC

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 % DailyValue % Daily Value forPregnant &Lactating Women
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 Glycinate) Sumalate® 75 mg 417% 417%
Folate (as ((6S)-N5-methyltetrahydrofolicacid calcium salt (molar equivalent to 600mcg 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.

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 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
(click image for full-size original)
FERIVA 21 7 ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acids and succinic acid tablet
Product Information
Product Type Item Code (Source) NDC:75854-318
Route of Administration ORAL DEA Schedule
Active Ingredient/Active Moiety
Ingredient Name Basis of Strength Strength
ASCORBIC ACID (ASCORBIC ACID) ASCORBIC ACID 175 mg
ZINC GLYCINATE (ZINC CATION) ZINC GLYCINATE 10 mg
CYANOCOBALAMIN (CYANOCOBALAMIN) CYANOCOBALAMIN 12 ug
FERROUS ASPARTO GLYCINATE (FERROUS CATION) FERROUS CATION 75 mg
FOLIC ACID (FOLIC ACID) FOLIC ACID 1 mg
SUCCINIC ACID (SUCCINIC ACID) SUCCINIC ACID 150 mg
Inactive Ingredients
Ingredient Name Strength
ANHYDROUS DIBASIC CALCIUM PHOSPHATE
MICROCRYSTALLINE CELLULOSE
STEARIC ACID
SILICON DIOXIDE
MAGNESIUM STEARATE
CROSCARMELLOSE SODIUM
HYPROMELLOSE, UNSPECIFIED
TITANIUM DIOXIDE
TRIACETIN
FD&C RED NO. 3
FD&C RED NO. 40
FD&C BLUE NO. 1
Product Characteristics
Color RED (red) , PURPLE (purple) Score no score
Shape OVAL (oval) Size 7mm
Flavor Imprint Code 21;7
Contains
Packaging
# Item Code Package Description Multilevel Packaging
1 NDC:75854-318-28 28 BLISTER PACK in 1 CARTON contains a BLISTER PACK
1 1 TABLET in 1 BLISTER PACK This package is contained within the CARTON (75854-318-28)
Marketing Information
Marketing Category Application Number or Monograph Citation Marketing Start Date Marketing End Date
DIETARY SUPPLEMENT 10/20/2014
Labeler — Avion Pharmaceuticals, LLC (040348516)
Establishment
Name Address ID/FEI Operations
Avion Pharmaceuticals, LLC 040348516 manufacture (75854-318)

Revised: 01/2020 Avion Pharmaceuticals, LLC

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