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

Group: Color

Also known as: FD&C Blue #1

Group: Color

UNII Code: H3R47K3TBD

Group: Color

Folacin

vitamin

Group: Vitamin B9 (folic acid)

Also known as: Folic Acid

Folate

vitamin

Group: Vitamin B9 (Folate)

Folate, also known as Vitamin B9, is a water-soluble vitamin essential for DNA synthesis, cell growth, and the production of red blood cells. It is important for proper brain function and plays a crucial role in mental and emotional health. Folate is naturally found in a wide range of foods, including leafy green vegetables, fruits, nuts, beans, and dairy products. It is also available as a dietary supplement and is typically included in B-vitamin complexes.

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

Also known as: HPMC

UNII Code: 3NXW29V3WO

Group: Cellulose

Microcrystalline cellulose (MCC) is a refined wood pulp that is commonly used as a texturizer, anti-caking agent, and bulking agent in food and dietary supplements. It is a white, odorless powder that is insoluble in water and is often used to improve the texture and stability of products.

Also known as: Cellulose, MCC

Quali-C

vitamin

Group: Vitamin C (ascorbic acid)

Also known as: Vitamin C

Group: Color

Red 40, also known as Allura Red AC, is a synthetic azo dye derived from petroleum used extensively as a red food colorant. It is approved by the FDA for use in foods, beverages, cosmetics, and pharmaceuticals. It imparts a bright red hue and is commonly found in candies, soft drinks, baked goods, and other processed products.

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

UNII Code: 2Z6R9D8D4B

Group: Silicon

Also known as: SiO2

UNII Code: ETJ7Z6XBU4

Stearic Acid

fatty acid

Group: Stearic Acid

Also known as: C18:0

UNII Code: 4ELV7Z65AP

Succinic Acid

non-nutrient/non-botanical

Group: Succinic acid

UNII Code: AB6MNQ6J6L

Triacetin

non-nutrient/non-botanical

Group: Triacetin

Triacetin, also known as glyceryl triacetate, is a triglyceride derived from the esterification of glycerol with acetic acid. It is commonly used as a plasticizer in the production of many biodegradable polymers, but it also finds diverse applications in flavorings, fragrances, and pharmaceuticals. Triacetin is often included as an additive in food products and supplements to facilitate the mixing of ingredients and improve texture.

Group: Vitamin B12

UNII Code: 8406EY2OQA

Group: Folate

Vitamin B9, commonly known as folic acid or folate, is a B-vitamin essential for various bodily functions, including DNA synthesis and repair, cell division, and growth. It is particularly important during periods of rapid growth such as during pregnancy and fetal development. Folic acid is the synthetic form often used in supplements and fortified foods, while folate is the naturally occurring form found in certain foods.

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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