FeRiva 21/7

Basic Information

Product Label

Product label for FeRiva 21/7
Full Name: FeRiva 21/7
Brand: Avion Pharmaceuticals none
Product Type: Other Combinations
Physical State: Tablet or Pill
UPC/SKU: 3 75854 31828 2
Product Version Code: Rev. 1219-02

Contact Information

Name: Avion Pharmaceuticals, LLC
Address:Alpharetta, GA, 30005
Phone: 1.888.612.8466
Types: Manufacturer

Product Details

Net Contents

28 Tablet(s)(28 Tablet(s))

Serving Sizes

Unit:Tablet(s)
Quantity:1 - 1
Daily Servings:1 - 1

Target Groups

Adult (18 - 50 Years)Pregnant WomenLactating

Servings Per Container

28

Ingredients & Nutrition

Folate

vitamin
Amount: 1200 mcg DFE
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: 430%
Pregnant and Lactating: 280%

Group: Vitamin B9 (Folate)

Iron

mineral
Forms:
  • as Ferrous Asparto Glycinate
Amount: 75 mg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: 417%
Pregnant and Lactating: 417%

Group: Iron

Succinic Acid

non-nutrient/non-botanical
Amount: 150 mg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: % (Daily Value (DV) Not Established)
Pregnant and Lactating: % (Daily Value (DV) Not Established)

Group: Succinic acid

UNII Code: AB6MNQ6J6L

Forms:
  • Cyanocobalamin
Amount: 12 mcg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: 200%
Pregnant and Lactating: 150%

Group: Vitamin B12

UNII Code: 8406EY2OQA

Vitamin C

vitamin
Forms:
  • Ascorbic Acid
Amount: 175 mg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: 292%
Pregnant and Lactating: 292%

Group: Vitamin C (unspecified)

Zinc

mineral
Forms:
  • Zinc Bisglycinate
Amount: 10 mg
Serving Size: 1 Tablet(s)
Adults and children 4 or more years of age: 67%
Pregnant and Lactating: 67%

Group: Zinc

Group: Color

Also known as: E129 FD&C Red No. 40, FD&C Red #40

Group: Color

Also known as: FD&C Blue #1

Group: Croscarmellose Sodium

Group: Calcium

Group: Color

Group: Color

Group: Color

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folic Acid

vitamin

Group: Folate

Also known as: Orgen-FA, Vitamin B9, Quatrefolic, Folacin, CitraFolic, B9, Folate

UNII Code: 935E97BOY8

Glyceryl Triacetate

non-nutrient/non-botanical

Group: Triacetin

Also known as: Triacetin

HPMC

other

Group: Hypromellose

Also known as: Hydroxypropylmethylcellulose, Hydroxypropyl Methyl Cellulose, Hydroxypropyl Methylcellulose, Hypromellose

Group: Hypromellose

Group: Magnesium stearate

MCC

other

Group: Cellulose

Also known as: Microcrystalline Cellulose

Group: Cellulose

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Group: Titanium Dioxide

Triacetin

non-nutrient/non-botanical

Group: Triacetin

Vitamin B9

vitamin

Group: Folate

Also known as: Folic Acid, Folate

UNII Code: 935E97BOY8

Product Statements

General Statements: All Other Content

75854-318-28 RX only

FDA Statement of Identity

Dietary Supplement

Formulation re: Other

Unique, innovative iron supplementation system Enhanced GI tolerability Improved absorption Easy-to-swallow tablets

Suggested/Recommended/Usage/Directions

Once daily 28-day iron supplement regimen

Formula re: Contains

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.

Formulation re: Other

Indications: FeRiva 21/7 is a multivitamin/multimineral dietary supplement indicated for use in improving the nutritional status of patients with iron deficiency. Contraindictions: FeRiva 21/7 is contraindicated in patients with a known hypersensitivity to any of the ingredients. Hemochromatosis and hemosiderosis are contraindicated to iron therapy.

Precautions re: Children

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 re: All Other

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.

Precautions re: Pregnant or Nursing or Prescription Medications

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.

Precautions re: Allergies

Adverse reactions: Allergic sensitization has been reported following both oral and parenteral administration of folic acid.

Suggested/Recommended/Usage/Directions

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.

Formula re: Contains

How supplied: FeRiva 21/7 tablets blister pack (75854-318-28) contains 21 red iron tablets and 7 purple placebo tablets.

General Statements: All Other Content

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 re: Children

Keep out of reach of children.

Storage

Store between 20 degrees - 25 degrees C (68 degrees - 77 degrees F).

Brand IP Statement(s) re: (c), (TM), (SM)

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.

General Statements: All Other Content

L-0057

FDA Disclaimer Statement

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.

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