FERIVA 21 7- ascorbic acid, zinc glycinate, cyanocobalamin, ferrous asparto glycinate, folic acid, docusate sodium and succinic acid tablet
Avion Pharmaceuticals, LLC
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 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.
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.
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.
*
Daily Value (DV) not established.
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 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-methyltetrahydrofolic
acid calcium
salt (molar equivalent to 600
mcg of folic acid) and folic acid,
USP 400 mcg) 1 mg 250% 125%
Docusate Sodium 50 mg * *
Succinic Acid 150 mg * *
PURPLE PLACEBO TABLETS do not contain ANY vitamins, minerals or other dietary ingredients. Please see OTHER INGREDIENTS section below for the listing of the placebo ingredients.
OTHER INGREDIENTS (RED IRON TABLETS): Dicalcium phosphate, microcrystalline cellulose, stearic acid, silicon dioxide, magnesium stearate and croscarmellose sodium.
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.
PRECAUTIONS/WARNING: 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.
STORAGE: Store between 20�- 25�C (68�- 77�F)
HEALTH CLAIMS: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.
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